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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

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(Last updated: October 04, 2024)

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Click here to view online studies and trials that do not require site visits

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: 3 or 5 visits, over 5 years

PHASE: III

NCT ID: NCT03233191

Breast Cancer Screening Based on Individual Risk Factors and Comparing the Effectiveness of 3D to 2D Mammography

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) Scientific Title

Purpose

To study if risk-based screening for breast cancer is as safe and effective as age-based screening and if (3D) mammography is better than (2D) mammography at finding early-stage tumors.

Who is this for?

Women, age 45 to 74, who have never been diagnosed with DCIS or breast cancer. You must not have had a screening mammogram within the last 11 months Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Digital mammogram (2D) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">if you are premenopausal or postmenopausal with 1 risk factor, mammogram, once a year, for five years</li> <li class="seamTextUnorderedListItem">if you are postmenopausal, mammogram, every 2 years, for five years</li> </ul> Group 2: Digital tomosynthesis mammogram (3D) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">if you are premenopausal or postmenopausal with 1 risk factor, mammogram, once a year, for five years</li> <li class="seamTextUnorderedListItem">if you are postmenopausal, mammogram, every 2 years, for five years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Most breast cancer screening guidelines are based upon a woman's age--not her individualized risk of developing breast cancer. </li> <li class="seamTextUnorderedListItem">For this trial, you will receive annual mammograms if you are premenopausal or postmenopausal with at least one risk factor.</li> <li class="seamTextUnorderedListItem">Risk factors if you are 45-69: dense breasts, a first degree relative with breast cancer, an inherited genetic mutation that increases your risk of developing cancer, or taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Risk factors if you are 70-74: dense breasts or taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Digital tomosynthesis (3D) mammography is approved by the FDA but is not considered the standard of care for breast cancer screening.</li> <li class="seamTextUnorderedListItem">Digital (2D) mammography is the standard of care for breast cancer screening.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03233191' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/tmist' target='_blank'>ECOG-ACRIN Cancer Research Group Trial Information Page: TMIST</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/dig_tomosynth' target='_blank'>Breastcancer.org: Digital Tomosynthesis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/tmist-breast-cancer-screening' target='_blank'>NCI Cancer Currents Blog: TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches</a> </li></ul>

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: 1 visit every 3 weeks, for 10 months

PHASE: III

NCT ID: NCT04457596

Two Therapies for People with Stage II-III HER2+ Breast Cancer Who Had Leftover Tumor after Receiving Neoadjuvant Therapy and Surgery

The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib Scientific Title

Purpose

To study the anti-cancer activity and side-effects of giving the antibody-drug conjugate trastuzumab emtansine/T-DM1 (Kadcyla®) and the anti-HER2 targeted therapy tucatinib (Tukysa®) after surgery.

Who is this for?

People with stage II or stage III HER2-positive breast cancer who received chemotherapy and trastuzumab (or pertuzumab and margetuximab) before surgery. During your surgery, leftover tumor must have been found in your breast or lymph node (residual disease). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following for up to 10 months: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily, </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, twice daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is an anti-HER2-targeted therapy approved for use with specific other therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -- to directly deliver the chemotherapy DM1 to the cancer cells. It is approved for use in people who had some leftover tumor (residual disease) after receiving neoadjuvant (before surgery) therapies, but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04457596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/residual-disease' target='_blank'>NCI Dictionary of Cancer Terms: Residual Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/kadcyla-fda-breast-her2-adjuvant' target='_blank'>NCI Cancer Currents Blog: T-DM1 Approval Expanded to Include Some Women with Early-Stage HER2-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Kadcyla (Trastuzumab emtansine/T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/tukysa' target='_blank'>Breastcancer.org: Tukysa (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/personalizing-her2-targeted-treatment-strategies-in-early-stage-and-advanced-breast-cancer' target='_blank'>OncLive: Personalizing HER2-Targeted Treatment Strategies in Early-Stage and Advanced Breast Cancer</a> </li></ul>

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05514054

Imlunestrant Hormone Therapy for Stage I-III ER+, HER2- Breast Cancer

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of imlunestrant, an experimental hormone therapy, compared to standard hormone therapy.

Who is this for?

People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received 2-5 years of hormone therapy after surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356) is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05514054' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Oral SERDs for Estrogen Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.loxooncology.com/pipeline/ly3484356' target='_blank'>Eli Lilly Drug Information Page: Imlunestrant (LY3484356)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05812807

Pembrolizumab Immunotherapy or Observation to Prevent Recurrence for Stage I-III Triple Negative Breast Cancer

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy Scientific Title

Purpose

To determine if observation will result in the same risk of cancer coming back (recurrence) as pembrolizumab (Keytruda®) immunotherapy after neoadjuvant (before surgery) therapy and surgery.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have no residual disease after neoadjuvant (before surgery) chemotherapy and pembolizumab (Keytruda®) and negative margins after surgery. You must have received surgery less than 3 months ago. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation (no treatment)</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Immunotherapy may help the body's immune system attack cancer and may reduce the ability of tumor cells to grow and spread.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</li> <li class="seamTextUnorderedListItem">A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed.</li> <li class="seamTextUnorderedListItem">In this trial, ER and PR low are defined as 1-10% of cells that are ER or PR positive.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05812807' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: 1 visit every 1-2 weeks for 5 months

PHASE: III

NCT ID: NCT06058377

Chemotherapy with Durvalumab Immunotherapy Before Surgery for Women with Stage II-III HR+, HER2- Breast Cancer

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care neoadjuvant (before surgery) chemotherapy with and without durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?

Women with newly diagnosed stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment. You must have a MammaPrint score of -1.0 to -0.57. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram</li> <li class="seamTextUnorderedListItem">MammaPrint testing (if not yet received)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2 weeks 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram</li> <li class="seamTextUnorderedListItem">MammaPrint testing (if not yet received)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2 weeks 2 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">A mammogram is a breast cancer screening procedure involving taking an x-ray picture of the breast.</li> <li class="seamTextUnorderedListItem">MammaPrint® is a genetic test that use tumor samples to help guide treatment decisions and determine risk of recurrence (cancer coming back).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html#:~:text=Durvalumab%20injection%20is%20in%20a,the%20growth%20of%20cancer%20cells.' target='_blank'>Medline Plus: Durvalumab (Imfinzi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint Test</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA

VISITS: 1 visit every week for 3-6 months

PHASE: II

NCT ID: NCT01042379

I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.

Who is this for?

People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following before surgery: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Online surveys

PHASE: NA

NCT ID: NCT02620852

WISDOM Study: Women Informed to Screen Depending on Measures of Risk

Enabling a Paradigm Shift: A Preference-Tolerant RCT of Personalized vs. Annual Screening for Breast Cancer Scientific Title

Purpose

To learn if risk-based breast screening is as safe and effective as annual mammogram screening for reducing risk and detecting breast cancer.

Who is this for?

Women between the ages of 40 and 70 who have never been diagnosed with breast cancer or ductal carcinoma in situ (DCIS). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups, or you can choose your study group. Group 1: Personalized, Risk-Based Screening <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Screening recommendations based on comprehensive, personal risk assessment</li> <li class="seamTextUnorderedListItem">Saliva sample genetic test</li> <li class="seamTextUnorderedListItem">Online, annual health questionnaires</li> </ul> Group 2: Standard Annual Screening <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Screening recommendation for annual mammograms</li> <li class="seamTextUnorderedListItem">Online, annual health questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized risk-based screening will take multiple risk factors into consideration, including genetic markers, to determine how often you should have a mammogram.</li> <li class="seamTextUnorderedListItem">This study will help researchers learn if risk-based screening, which helps women learn more about their personal breast cancer risk, is less stressful and as successful at detecting breast cancer as annual screening. </li> <li class="seamTextUnorderedListItem">This study is available in English and Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02620852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thewisdomstudy.org/' target='_blank'>WISDOM: Study Information Page</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente - San Francisco Medical Center
San Francisco,CA

VISITS: Coincides with targeted therapy

PHASE: II

NCT ID: NCT02693535

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a genomic or immunohistochemistry test approved by TAPUR. Full eligibility criteria

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You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable, over 4 months

PHASE: NA

NCT ID: NCT02872025

Pembrolizumab Before Surgery for Women With High-Risk DCIS

Testing the Ability of Pembrolizumab to Alter the Tumor Immune MicroEnvironment (TIME) of High Risk DCIS Scientific Title

Purpose

To study the effects (good and bad) of the immunotherapy pembroluzuimab on DCIS and the tissue surrounding DCIS.

Who is this for?

Women with high-risk DCIS planning to have surgery (mastectomy or lumpectomy). Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI, at diagnosis and right before surgery</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by injection directly into the DCIS, 4 times, with 2 to 4 weeks between each injection</li> <li class="seamTextUnorderedListItem">Surgery (lumpectomy or mastectomy), 1 to 5 weeks after your last injection</li> </ul> Group 2: Standard care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI, at diagnosis and right before surgery</li> <li class="seamTextUnorderedListItem">Tissue collection (biopsy of DCIS)</li> <li class="seamTextUnorderedListItem">Surgery (lumpectomy or mastectomy), within 4 months of diagnosis</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">It is usually given by IV, but for this study it will be injected directly into the DCIS. </li> <li class="seamTextUnorderedListItem">Giving pembrolizumab (Keytruda®) before surgery allows researchers to study the effects it has on DCIS and the microenvironment (the tissue surrounding the DCIS).</li> <li class="seamTextUnorderedListItem">For this trial, high-risk DCIS means you meet at least 2 of the following: you are younger than 45, the DCIS is palpable (able to be felt by touch), larger than 5 cm, grade II-III, HER2 positive (HER2+), or hormone receptor negative (ER- and PR-).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02872025' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/dcis/diagnosis' target='_blank'>Breastcancer.org: Diagnosis of DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforDuctalCarcinomaInSitu.html' target='_blank'>Susan G. Komen: Treatment for DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT02872025' target='_blank'>University of California San Francisco: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/researchers/laura-j-esserman' target='_blank'>BCRF: Laura J. Esserman (Study Researcher)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=Cj0KCQjw6sHzBRCbARIsAF8FMpU1aXb3OCAoZH-Kz-lr_9qfn5S-yKDUnZ6zjvh8GAJBRQ5kuy7Ih0caAlUVE' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Breast Care Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03053193

The FLEX Registry: MammaPrint Testing With or Without BluePrint Testing For People With Stage I-III Breast Cancer

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry) Scientific Title

Purpose

To create a large registry of tumor samples to help researchers find new cancer biomarkers and design future clinical trials.

Who is this for?

People with stage I, stage II, or stage III breast cancer who received MammaPrint testing, with or without BluePrint genomic testing, of their tumor. Full eligibility criteria

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For this data collection registry, you will: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide a sample of your tumor (taken during a routine procedure)</li> <li class="seamTextUnorderedListItem">Allow information about your breast cancer treatment to be included in the registry</li> <li class="seamTextUnorderedListItem">Information will be collected from you when you enroll in the registry, during treatment, 1 year after treatment ends; and 2, 5, and 10 years after your diagnosis</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The FLEX Registry will create a database of clinical and genomic information collected from patients who have had their tumor tested with MammaPrint, with or without BluePrint genomic testing. </li> <li class="seamTextUnorderedListItem">MammaPrint is a diagnostic test done on a tumor sample to help guide treatment decisions. The results tell you and your doctor if you have a low or high risk of recurrence. </li> <li class="seamTextUnorderedListItem">BluePrint is a molecular test done on the tumor sample to further classify your risk of recurrence.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03053193' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.agendia.com/clinical-trials/ongoing-studies/' target='_blank'>Trial Sponsor Information Page: FLEX Registry</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/genomic_assays' target='_blank'>Breastcancer.org: Tumor Genomic Assay Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/mammaprint' target='_blank'>Breastcancer.org: MammaPrint Test</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.agendia.com/our-tests/mammaprint/' target='_blank'>Agendia Information Page: MammaPrint Test</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.agendia.com/diagnostic-products/blueprint.html#' target='_blank'>Agendia Information Page: BluePrint Test</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Centre
San Francisco,CA

VISITS: 21 visits over 2 years

PHASE: III

NCT ID: NCT03562637

An Immunotherapy Combination for Stage I-III Triple Negative Breast or ER Low, HER2- Cancer That is Globo H Positive

A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (OBI 822)/OBI 821 Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients, Defined as Residual Invasive Disease Following Neoadjuvant Chemotherapy OR ≥4 Positive Axillary Nodes Scientific Title

Purpose

To study the safety and anti-cancer activity of a combination of 2 experimental immunotherapies, adagloxad simolenin (OBI-822) and OBI-821.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who have completed treatment less than 3 months ago. You must have had cancer cells remaining if you had neoadjuvant (before surgery) chemotherapy or had 4 or more positive lymph nodes at the time of surgery if you had adjuvant (after surgery) chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) combined with OBI-821, by injection, 21 times over 2 years </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by injection, 21 times over 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) is the investigational immunotherapy used in this study. </li> <li class="seamTextUnorderedListItem">It is given along with the investigational drug OBI-821, which is designed to help stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03562637' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT03562637' target='_blank'>UCSF Trial Information Page: GLORIA</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/adagloxad-simolenin/' target='_blank'>Immuno-Oncology News: Adagloxad Simolenin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/saponin-based-immunoadjuvant-obi-821' target='_blank'>NCI Drug Dictionary: OBI-821</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/80/4_Supplement/OT1-08-03' target='_blank'>AACR Abstract: (OBI-822) and OBI-821</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03589339

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of NBTXR3, an experimental nanoparticle, and stereotaxic ablative radiotherapy, with nivolumab (Opdivo®) or pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the soft tissues, lungs, or liver. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3, by intratumoral injection, 1 time</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) or pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3 is an experimental nanoparticle designed to kill cancer cells that is activated by stereotaxic ablative radiotherapy.</li> <li class="seamTextUnorderedListItem">NBTXR3 will be injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy, also called stereotactic radiation or stereotactic radiosurgery, delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03589339' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nanobiotix.com/clinical-trials/' target='_blank'>Nanobiotix Drug Information Page: NBTXR3</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotaxic Ablative Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT03971409

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe) Scientific Title

Purpose

To look at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) or ER Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-04518600, by IV, every 2 weeks </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab, by IV, once a month</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. </li> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03971409' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/avelumab' target='_blank'>NCI Drug Dictionary: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pf-04518600/' target='_blank'>Immuno-Oncology News: PF-04518600</a> </li><li class='seamTextUnorderedListItem'><a href='https://pfe-pfizercom-prod.s3.amazonaws.com/news/asco/Pfizer_IO_41BB_UtomilumabFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/binimetinib' target='_blank'>NCI Drug Dictionary: Binimetinib</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center-Mission Bay/Benioff Children's Hospital
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03990896

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) BRCA1/2 Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial Scientific Title

Purpose

To study the anti-cancer activity of the PARP inhibitor Talazoparib (Talzenna®) in breast cancer tumors that test positive for a tumor (not inherited) BRCA 1 or BRCA 2 mutation.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Your tumor must test positive for a BRCA 1 or a BRCA 2 tumor (not inherited) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called germline when they are inherited. </li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called somatic when they are not inherited.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA 1 (tumor), BRCA 2 (tumor)</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03990896' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation' target='_blank'>NCI Drug Dictionary: Somatic Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109817433' target='_blank'>Pfizer Oncology: Talzenna®</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2016/07/how-do-parp-inhibitors-work-in-cancer/' target='_blank'>Dana-Farber Cancer Institue: How Do PARP Inhibitors Work In Cancer? (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2017/vol-18-no-13/blurring-the-lines-between-germline-and-somatic-mutations-in-cancer' target='_blank'>OncLive: Blurring the Lines Between Germline and Somatic Mutations in Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41416-018-0127-5' target='_blank'>Journal Article: BRCA1/2 Testing: Therapeutic Implications for Breast Cancer Management</a> </li></ul>

NEAREST SITE: 3 miles
Univ. of Cali. San Francisco Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04042701

Trastuzumab Deruxtecan ADC and Pembrolizumab Immunotherapy for Advanced HER2 Positive and HER2 Low Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received trastuzumab emtansine/T-DM1 (Kadcyla®) or standard of care therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy directly to the cancer cells. It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PD-1 allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042701' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer' target='_blank'>FDA: FDA Approves Fam-Trastuzumab Deruxtecan-nxki</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fam-trastuzumab-deruxtecan' target='_blank'>NCI Drug Dictionary: Fam-Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/february-2020/trastuzumab-deruxtecan-in-her2-low-expressing-previously-treated-advanced-breast-cancer/' target='_blank'>ASCO Post: Trastuzumab Deruxtecan in HER2–Low-Expressing, Previously Treated Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda)</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04143711

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Metastatic Breast Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of DF1001 when it is given alone or with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests HER2 1+, 2+ or 3+ on the IHC (immunohistochemistry) tumor test and have not had more than three lines of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 immunotherapy</li> </ul> You may also receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 is an experimental immunotherapy. </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04143711' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/msi-h/' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dragonflytx.com/copy-of-about-us-1' target='_blank'>Dragonfly Therapeutics Information Page: DF1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554437/' target='_blank'>Journal Article: Cancer Immunotherapy Based on Natural Killer Cells: Current Progress and New Opportunities</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/keytruda-approved-for-microsatellite-instability-high-and-mismatch-repair-deficient-cancers' target='_blank'>Cure Today: Keytruda Approved for Any Solid Tumor With a Specific Genetic Marker</a> </li></ul>

NEAREST SITE: 3 miles
Curebase
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04510129

Collecting Tumor Samples to Develop a Test to Predict Response to Treatment

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies Scientific Title

Purpose

To collect tumor samples that will be used to develop OncoPrism™, a test that helps providers predict response to immunotherapy.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer who have received or are planning to receive treatment with a PD-1/PD-L1 inhibitor. You must have received a biopsy before beginning treatment with a PD-1/PD-L1 inhibitor. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OncoPrism™ is a test that helps providers predict response to immunotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04510129' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cofactorgenomics.com/technology/' target='_blank'>Cofactor Genomics: OncoPrism™ Test</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04606446

Experimental Therapy PF-07248144 for Advanced ER+, HER2- Breast Cancer

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic Solid Tumors. Scientific Title

Purpose

To study the safety, side effects, dose, and anti-cancer activity of giving PF-07248144 alone, in combination with fulvestrant, or with palbociclib and letrozole.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed after receiving a CDK 4/6 inhibitor and anti-estrogen therapy. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144 is a KAT6 Inhibitor</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04606446' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04606446' target='_blank'>Pfizer Trial Information Page: PF-07248144</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/update-on-hormone-receptor-positive-mbc-2021/' target='_blank'>Metastatic Trial Talk: Update on Hormone Receptor-Positive MBC</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco (UCSF)
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04802759

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER) Scientific Title

Purpose

To study the anti-cancer activity and safety of giving the experimental anti-estrogen therapy giredestrant alone or with a CDK 4/6 inhibitor, an AKT inhibitor, a PI3K inhibitor, or chemotherapy.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor and who have not received chemotherapy for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Faslodex is given by injection. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is also a CDK 4/6 inhibitor. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an experimental type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT. </li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental type of targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Inavolisib may slow or stop cancer cells from growing by blocking this pathway. </li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04802759' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant (GDC-9545)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors (Abemaciclib & Ribociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib (AKT Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/everolimus.aspx' target='_blank'>Chemocare: Everolimus (Afinitor)</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: 2 visits

PHASE: II

NCT ID: NCT04821141

Bazedoxifene and Estrogen Hormone Therapy to Reduce Risk Factors for Developing Breast Cancer

Randomized IIB Study of the Effect of Bazedoxifene Plus Conjugated Estrogens on Breast Imaging and Tissue Biomarkers in Peri or Post-Menopausal Women at Increased Risk for Development of Breast Cancer Scientific Title

Purpose

To study whether bazedoxifene and estrogen affect risk factors associated with developing breast cancer.

Who is this for?

Perimenopausal and postmenopausal women ages 45 to 60 who experience hot flashes and/or night sweats at least once a week and have a moderate risk of developing breast cancer. Risk factors include a family history of breast cancer, prior breast biopsies, or one of the following gene mutations: ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, STK11, P53, PTEN. You must not have a BRCA1/2 mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bazedoxifene, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Estrogen, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Mammogram, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Fine needle aspiration biopsy, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Fine needle aspiration biopsy, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 6 months</li> </ul> followed 6 months later by (optional): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bazedoxifene, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Estrogen, by mouth, daily for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bazedoxifene is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. It may help reduce the risk of breast cancer.</li> <li class="seamTextUnorderedListItem">Estrogen is a hormone used to treat women experiencing hot flashes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04821141' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2022-03864&r=1#:~:text=Giving%20bazedoxifene%20with%20conjugated%20estrogens,increased%20risk%20for%20breast%20cancer.' target='_blank'>National Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a614004.html' target='_blank'>Medline Plus: Bazedoxifene and Estrogen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/cancer/breast/basic_info/mammograms.htm' target='_blank'>Centers for Disease Control and Prevention: Mammogram</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/breast-biopsy/fine-needle-aspiration-biopsy-of-the-breast.html#:~:text=During%20a%20fine%20needle%20aspiration,needle%20biopsy%20is%20often%20preferred).' target='_blank'>American Cancer Society: Fine Needle Aspiration Biopsy</a> </li></ul>

NEAREST SITE: 3 miles
Research Site
San Francisco,CA

VISITS: 1 visit every month, ongoing

PHASE: II

NCT ID: NCT04829604

Antibody-Drug Conjugate ARX788 for Metastatic HER2 Positive Breast Cancer

A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens Scientific Title

Purpose

To study the safety, anti-cancer activity, and side effects of the investigational antibody-drug conjugate ARX788.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already received tucatinib (Tukysa®), T-DM1 (Kadcyla®), or trastuzumab deruxtecan (Enhertu®) in the metastatic setting. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788, by IV, once a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibody-drug conjugates (ADCs) are therapies that contain an antibody linked to a specific type of chemotherapy. They are designed to deliver high doses of chemotherapy to cancer cells while sparing normal cells. </li> <li class="seamTextUnorderedListItem">ARX788 is an investigational antibody-drug conjugate -- this means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">ARX788 targets HER2 to deliver the chemotherapy AS269 directly to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04829604' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-grants-fast-track-status-to-adc-arx788-for-her2-metastatic-breast-cancer' target='_blank'>OncLive: FDA Grants Fast Track Status to ADC ARX788 for HER2+ Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04852887

Hormone Therapy Alone or With Radiation for Stage I HR+, HER2- Breast Cancer

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) and anti-cancer activity of hormone therapy alone or with radiation after a lumpectomy.

Who is this for?

People with stage I hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received a lumpectomy within the past 3 months. You must not have received chemotherapy or radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Hormone Therapy and Radiation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®), daily, at least 5 years</li> <li class="seamTextUnorderedListItem">Radiation</li> </ul> Group 2: Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®), daily, at least 5 years</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04852887' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nrgoncology.org/Home/News/Post/NRG-BR007-The-DEBRA-Trial' target='_blank'>NRG Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 3 miles
Research Site
San Francisco,CA

VISITS: 1 visit per month, ongoing

PHASE: III

NCT ID: NCT04862663

Capivasertib, Palbociclib, and Fulvestrant for Advanced ER+, HER2- Breast Cancer

A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer Scientific Title

Purpose

To study the dose, safety, side effects, and anti-cancer activity of giving the targeted therapies capivasertib and palbociclib (Ibrance®) with the anti-estrogen therapy fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer. Your cancer must have progressed on anti-estrogen therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, daily (4 days on, 3 days off), ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy that blocks the Akt protein. The Akt protein helps cancer cells divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. It is approved for treating metastatic hormone-positive, HER2-negative breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04862663' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/capivasertib?redirect=true' target='_blank'>NCI Drug Dictionary: Capivasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30857-5/fulltext' target='_blank'>Journal Article: Capivasertib Inhibits a Key Pathway in Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615013.html' target='_blank'>Medline Plus: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Fulvestrant' target='_blank'>Wikipedia: Fulvestrant</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, for 1 year

PHASE: II

NCT ID: NCT04893109

Trastuzumab by Injection with Chemotherapy or an Antibody-Drug Conjugate for Stage I HER2 Positive Breast Cancer

A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0) Scientific Title

Purpose

To study and compare the safety, side effects, and anti-cancer activity of giving Herceptin Hylecta (trastuzumab by injection) with chemotherapy to giving it with an antibody-drug conjugate.

Who is this for?

People with stage I HER2-positive (HER2+) breast cancer who have already had surgery and completed radiation therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 7.5 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 11.5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -— to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Herceptin Hylecta is a form of trastuzumab that is given by injection instead of by IV. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04893109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-formulation-herceptin-subcutaneous-use' target='_blank'>FDA Drug Approvals and Database: FDA Approves New Formulation of Herceptin for subcutaneous Use</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine/T-DM1 (Kadcyla®)</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT05020574

Impact of Antibiotics on Infection and the Microbiome in People Receiving a Mastectomy

Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction Scientific Title

Purpose

To study the effects (good and bad) of antibiotics after mastectomy with immediate reconstruction on infection and the microbiome.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or some stage III breast cancer or people at risk of breast cancer who are planning to receive a mastectomy with immediate reconstruction. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) antibiotic, before and during surgery</li> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) antibiotic, daily for at least 7 days after surgery</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) antibiotic, before and during surgery</li> <li class="seamTextUnorderedListItem">No antibiotics after surgery (unless infection occurs)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A mastectomy is surgery to remove a breast.</li> <li class="seamTextUnorderedListItem">Women with a strong family history of breast cancer or a BRCA mutation may choose to undergo a mastectomy to reduce their risk of developing breast cancer.</li> <li class="seamTextUnorderedListItem">Cephalexin (Keflex®) is an antibiotic used to prevent infection after surgery.</li> <li class="seamTextUnorderedListItem">The microbiome consists of the many bacteria, viruses, and fungi found on your body.</li> <li class="seamTextUnorderedListItem">The harmful bacteria cause disease such as infection, and the beneficial bacteria help keep you healthy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05020574' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/surgery/mastectomy' target='_blank'>Breastcancer.org: Mastectomy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682733.html' target='_blank'>MedlinePlus: Cephalexin (Keflex®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05086692

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors (ABILITY) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of MDNA11, an experimental immunotherapy, alone and with a checkpoint inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Checkpoint inhibitor as determined by your physician</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11 is an experimental immunotherapy called interleukin-2 (IL-2).</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">A checkpoint inhibitor is a type of immunotherapy. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05086692' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medicenna.com/pipeline/mdna11/' target='_blank'>Medicenna Drug Information Page: MDNA11</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2021/12/22/2356750/0/en/Medicenna-Announces-Preliminary-Clinical-Data-Showing-Preferential-Stimulation-of-Anti-Cancer-Immune-Cells-with-MDNA11-Treatment-in-the-Phase-1-2-ABILITY-Study.html' target='_blank'>Medicenna Press Release: MDNA11 Treatment in the Phase 1/2 ABILITY Study</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cytokines' target='_blank'>Breastcancer.org: Interleukin-2</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/checkpoint-inhibitors' target='_blank'>Cancer Research UK: Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05107674

A Study of NX-1607 in Adults With Advanced Malignancies

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of NX-1607, an experimental CBL-B inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NX-1607, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NX-1607 is an experimental immunotherapy called a CBL-B inhibitor that stimulates the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05107674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nurixtx.com/pipeline/' target='_blank'>Nurix Therapeutics: NX-1607 Drug Information Page</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: 1 visit every month for 6 months, then every 6 months for 2.5 years

PHASE: III

NCT ID: NCT05232916

GLSI-100 Immunotherapy for HER2 Positive Breast Cancer

A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of GLSI-100, an experimental immunotherapy.

Who is this for?

People with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who have completed standard treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GLSI-100, by injection, monthly for 6 months, then every 6 months for 2.5 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for GLSI-100, by injection, monthly for 6 months, then every 6 months for 2.5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GLSI-100 is an experimental immunotherapy that targets HER2 positive cells.</li> <li class="seamTextUnorderedListItem">GLSI-100 has two components called GP2 and GM-CSF.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05232916' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://greenwichlifesciences.com/technology/gp2-cancer-immunotherapy/' target='_blank'>Greenwich LifeSciences: GP2 Drug Information Page</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05239143

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of P-MUC1C-ALLO1, an experimental CAR-T cell immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, 1 session</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, multiple sessions</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) may be given for safety</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 is an experimental immunotherapy called CAR-T cell therapy.</li> <li class="seamTextUnorderedListItem">Allogeneic CAR-T cell therapy is an immunotherapy made from donor immune cells.</li> <li class="seamTextUnorderedListItem">Donor immune cells are modified with chimeric antigen receptors (CARs) so they can attack cancer cells.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) is an enzyme that can be administered for safety to kill CAR-T cells, if needed.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05239143' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://poseida.com/science/pipeline/#cart-therapies' target='_blank'>Poseida Therapeutics Drug Information Page: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-p-muc1c-allo1-a-fully-allogeneic-car-t-targeting-multiple-solid-tumors-301447910.html' target='_blank'>Poseida Therapeutics Press Release: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bellicum.com/caspacide-safety-switch/' target='_blank'>Bellicum Phamaceuticals Drug Information Page: Rimiducid (CaspaCIDe®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2020.618427/full' target='_blank'>Journal Article: Allogeneic CAR T-Cell Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05252416

BLU-222 Targeted Therapy and Hormone Therapy for Advanced ER+, HER2- Breast Cancer

A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BLU-222, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that progressed after treatment with a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLU-222, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLU-222 is an experimental targeted therapy called a CDK 2 inhibitor. It may block an enzyme, CDK 2, that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05252416' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.blueprintmedicines.com/pipeline/' target='_blank'>Blueprint Medicines Corporation: BLU-222 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 3 miles
GSK Investigational Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05277051

GSK4381562 Immunotherapy for Advanced Breast Cancer

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of GSK4381562 (SRF813), an experimental immunotherapy, alone and with dostarlimab (Jemperli®), a type of immunotherapy called a PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813) is an experimental immunotherapy that targets PVRIG/SRF813 to activate immune cells to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05277051' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.surfaceoncology.com/news-releases/news-release-details/surface-oncology-achieves-30-million-milestone-first-patient' target='_blank'>Surface Oncology Press Release: First Patient Dosed with GSK4381562 (SRF813)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/jemperli' target='_blank'>Breastcancer.org: Dostarlimab (Jemperli®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
Research Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05417594

AZD9574 Targeted Therapy for Advanced HER2 Negative Breast Cancer With Certain Mutations

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AZD9574, an experimental PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a tumor or inherited BRCA1, BRCA2, PALB2, RAD51C, or RAD51D mutation. You must not have received treatment with a PARP inhibitor. You must have at least 1 tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9574, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9574 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">The mutations can be inherited (also called germline) or in a tumor (also called somatic).</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2, RAD51C, RAD51D</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417594' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://aacrjournals.org/cancerres/article/82/12_Supplement/2609/702588' target='_blank'>Abstract: AZD9574</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/parp-inhibitors/' target='_blank'>Susan G. Komen: PARP Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT05456373

Device to Detect Positive Margins During Lumpectomy

Intraoperative Use of ClearEdge Device in Breast Conserving Surgery Scientific Title

Purpose

To study whether the ClearEdge tissue imaging device helps detect positive margins during a lumpectomy.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who are planning to receive a lumpectomy. You must not have received chemotherapy or radiation to the affected breast. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care assessment of margins during surgery</li> <li class="seamTextUnorderedListItem">ClearEdge tissue imaging device</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care assessment of margins during surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The ClearEdge tissue imaging device uses a new technology to help the surgeon detect tissue abnormalities during surgery and identify cancer cells that would have been left behind (positive margins).</li> <li class="seamTextUnorderedListItem">This may allow the surgeon to remove all cancer cells during surgery and avoid cancer recurrence or the need to repeat surgery.</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy. It is a standard of care (routine) procedure that removes the tumor and a rim of surrounding normal tissue (margins) while leaving as much normal breast tissue as possible.</li> <li class="seamTextUnorderedListItem">A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05456373' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/surgery/lumpectomy' target='_blank'>Breastcancer.org: Lumpectomy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/margin' target='_blank'>National Cancer Institute: Clear Margins</a> </li><li class='seamTextUnorderedListItem'><a href='https://lsbiopath.com/patient/' target='_blank'>LSBiopath: ClearEdge Device Information Page</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco Health
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05508906

OP-1250 Hormone Therapy with Targeted Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of OP-1250, an experimental hormone therapy, with ribociclib (Kisqali®) CDK 4/6 inhibitor or alpelisib (Piqray®) PI3K inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1-2 hormone therapies for advanced or metastatic disease. You must not have received more than 1 chemotherapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250 is an experimental hormone therapy called a selective estrogen receptor downregulator (SERD) and complete estrogen receptor antagonist (CERAN). SERDs bind to and break down estrogen receptors, and CERANs block estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05508906' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/science/' target='_blank'>Olema Oncology Drug Information Page: OP-1250</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT05548127

ARV-471 Hormone Therapy with Abemaciclib for Advanced ER+, HER2- Breast Cancer

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-S... Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK 4/6 inhibitor and up to 2 lines of therapy for advanced/metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05548127' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05563220

Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy in combination with other anti-cancer therapies.

Who is this for?

People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not received treatment with chemotherapy or elacestrant (Orserdu®) for advanced/metastatic disease. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 4 groups based on your situation: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Physician's choice of palbociclib (Ibrance®), abemaciclib (Verzenio®), or ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05563220' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center-Mission Bay
San Francisco,CA

VISITS: Please contact research site

PHASE: II

NCT ID: NCT05564377

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH) Scientific Title

Purpose

To use genetic testing to match people to treatments and help doctors plan better treatments.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available. Full eligibility criteria

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA

VISITS: 1 visit every 3 months for 1.5 years

PHASE: NA

NCT ID: NCT05568472

Monitoring Symptoms to Help Women Continue Taking Hormone Therapy for Stage I-III Breast Cancer

A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN) Scientific Title

Purpose

To study if reporting symptoms by email, text, or phone helps women continue taking hormone therapy.

Who is this for?

Premenopausal or perimenopausal women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving or planning to receive hormone therapy. You must have received surgery within 2 weeks of beginning this trial. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Receive health education materials</li> <li class="seamTextUnorderedListItem">Attend clinic visits, every 3 months for 1.5 years</li> <li class="seamTextUnorderedListItem">Report symptoms, by email, text, or phone, weekly for 6 months, then monthly for 1 year</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Receive health education materials</li> <li class="seamTextUnorderedListItem">Attend clinic visits, every 3 months for 1.5 years</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy is a common treatment for hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Hormone therapy can cause side effects which may cause some women to stop treatment early. Asking about symptoms may help women continue taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Health education materials contain information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health.</li> <li class="seamTextUnorderedListItem">Questionnaires can be completed in English or Spanish.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05568472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20070906b' target='_blank'>Breastcancer.org: Side Effects of Hormone Therapy</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT05573555

ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with ribociclib (Kisqali®) CDK 4/6 inhibitor.

Who is this for?

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05573555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li></ul>

NEAREST SITE: 3 miles
Research Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05629585

Dato-DXd Antibody Drug Conjugate for Stage I-III Triple-Negative Breast Cancer

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of Dato-DXd with or without durvalumab (Imfinzi®) compared with investigator's choice of therapy.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer with cancer that still remains in the breast and/or lymph nodes after neoadjuvant (before surgery; containing an anthracycline and/or a taxane) and surgery. You must not have received systemic therapy after surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (abbreviated Dato-DXd), by IV, every 3 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks for 7 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (abbreviated Dato-DXd), by IV, every 3 weeks for 6 months</li> </ul> Group 3 (Investigator's Choice) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (for 2 weeks in a 3-week cycle) for 6 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 7 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (abbreviated Dato-DXd) is an antibody-drug conjugate that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor. It works by stimulating the body's immune system to go after cancer cells. It is approved to treat some cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05629585' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Dato-DXd</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/asco-2021/asco-2021-breast-cancer-in-depth/breast-cancer-durvalumab-neoadjuvant-chemo-treatment-risk/#:~:text=June%2024%2C%202021-,Durvalumab%20Improves%20Survival%20When%20Added%20to,in%2' target='_blank'>Cancer Therapy Advisor: Durvalumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center
San Francisco,CA

VISITS: 1-2 visits every 3 weeks for 6 months

PHASE: III

NCT ID: NCT05633654

Sacituzumab Govitecan with Pembrolizumab for Stage I-III Triple Negative Breast Cancer with Residual Disease

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan (Trodelvy®) antibody drug conjugate with pembrolizumab (Keytruda®) immunotherapy, a PD-1 inhibitor.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer with residual disease after neoadjuvant (before surgery) treatment and surgery. You must not have a BRCA mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off, 6 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months (optional)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan(Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05633654' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05694715

Niraparib Targeted Therapy and Irinotecan Chemotherapy for Advanced Breast Cancer with BRCA1, BRCA2, ATM, and PALB2 Mutations

Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of niraparib PARP inhibitor with irinotecan chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1, BRCA2, ATM, and/or PALB2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®) is a type of chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) and irinotecan (Camptosar®) are approved to treat certain types of cancer. Their use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, ATM, PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694715' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617007.html' target='_blank'>Medline Plus: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a608043.html' target='_blank'>Medline Plus: Irinotecan (Camptosar®)</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05705401

Anti-HER2 Targeted Therapy With or Without Radiation for Women with DCIS and Stage I-III HER2 Positive Breast Cancer

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care anti-HER2 targeted therapy with and without adjuvant (after surgery) radiation.

Who is this for?

People at least 40 years old with stage 0 (DCIS), stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have received a lumpectomy, chemotherapy, and anti-HER2 targeted therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care With Radiation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Radiation</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Standard of Care Without Radiation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Due to the low risk of recurrence (cancer coming back) of people in this trial, researchers think there may be a low benefit of radiation in addition to anti-HER2 targeted therapy after surgery.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®) are examples of anti-HER2 targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05705401' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05768139

STX-478 Targeted Therapy for Advanced HR+, HER2- Breast Cancer with a PI3K Mutation

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of STX-478, an experimental PI3K inhibitor, alone or with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PI3K mutation. You must not have a PTEN, AKT, or mTOR mutation. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478 is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PI3K</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05768139' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.scorpiontx.com/pipeline/' target='_blank'>Scorpion Therapeutics: STX-478 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05787587

IDE161 for Advanced Breast Cancer with a BRCA Mutation

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of IDE161, a PARG inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1/2 mutation whose cancer has progressed on at least one previous therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IDE-161, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IDE161 targets poly(ADP-ribose) glycohydrolase (PARG) and may block cancer cell growth in people with a BRCA1 mutation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05787587' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/phase-1-trial-of-ide161-doses-first-patient-with-advanced-solid-tumors' target='_blank'>Targeted Oncology: Trial for IDE161</a> </li><li class='seamTextUnorderedListItem'><a href='https://filecache.investorroom.com/mr5ir_ideayabio/277/AACR%20Annual%20Meeting%202023%20Poster%206093_PARG_Final.pdf' target='_blank'>Ideayabio Research Poster: IDE161</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Coincides with surgery

PHASE: III-IV

NCT ID: NCT05807074

Tranexamic Acid During Bilateral Mastectomy with Reconstruction for Prevention, DCIS, or Stage I-III Breast Cancer

The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery Scientific Title

Purpose

To study how well tranexamic acid reduces bleeding and fluid after bilateral mastectomy with immediate reconstruction.

Who is this for?

Women at high risk for breast cancer and women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer who are planning to receive a bilateral mastectomy with breast reconstruction at the University of California San Francisco. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bilateral mastectomy with immediate reconstruction</li> <li class="seamTextUnorderedListItem">Tranexamic acid (TXA) to one breast during surgery (experimental)</li> <li class="seamTextUnorderedListItem">Saline applied to one breast during surgery (control)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bleeding and fluid build-up are common complications after mastectomies which can interfere with breast reconstruction, increase the risk of infection, slow wound healing, and potentially delay cancer treatments.</li> <li class="seamTextUnorderedListItem">Tranexamic acid (TXA) is a drug that improves blood clotting. Applying it to the surgical site before closing the incision may prevent bleeding and fluid build-up.</li> <li class="seamTextUnorderedListItem">A bilateral mastectomy is a surgical procedure involving removing both breasts to prevent or remove breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05807074' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/surgery/mastectomy' target='_blank'>Breastcancer.org: Mastectomy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612021.html' target='_blank'>Medline Plus: Tranexamic Acid</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05831995

ABM-168 Targeted Therapy for Advanced Breast Cancer with RAS, RAF, or NF-1 Mutations

A Phase I, First-In-Human, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of ABM-168 Administered Orally in Adult Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ABM-168, an experimental MEK inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with RAS, RAF, or NF-1 mutations who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABM-168, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABM-168 is an experimental targeted therapy called a MEK inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05831995' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clinicaltrialsarena.com/news/abm-first-patient-solid-tumours/' target='_blank'>ABM Therapeutics Corporation: ABM-168 Press Release</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mek-inhibitor' target='_blank'>National Cancer Institute: MEK Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2022-0763.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Comprehensive Cancer Ctr
San Francisco,CA

VISITS: 1 visit every 1-2 weeks

PHASE: II

NCT ID: NCT05852691

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind Study of RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of RO7247669, an experimental targeted therapy, with nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is PD-L1 positive. You must have not yet received treatment for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669 is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">RO7247669 is a bispecific antibody that targets PD-1 (programmed death-1) and LAG-3 (lymphocyte-activation gene 3).</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05852691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tobemstomig' target='_blank'>National Cancer Institute: Tobemstomig (RO7247669)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-Paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05879926

Hormone Therapy and Ovarian Suppression With or Without Chemotherapy for Premenopausal Women with Stage I-III HR+, HER2- Breast Cancer

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of adding chemotherapy to treatment with aromatase inhibitor and ovarian function suppression.

Who is this for?

Premenopausal women 18-60 years old with stage I, stage II, or some stage III hormone receptor positive or low (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have received surgery and have an Oncotype DX score of less than 26. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, 5 years</li> <li class="seamTextUnorderedListItem">Ovarian function suppression, every 1-3 months, 5 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, 5 years</li> <li class="seamTextUnorderedListItem">Ovarian function suppression, every 1-3 months, 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that block some production of estrogen that helps cancer grow. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Ovarian suppression can stop the ovaries from making estrogen, putting you into temporary menopause. This prevents the tumor from receiving estrogen it needs to grow.</li> <li class="seamTextUnorderedListItem">The Oncotype DX test can help determine the chance of the cancer coming back and whether a person will benefit from chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05879926' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/ovarian-suppression/' target='_blank'>Susan G. Komen: Ovarian Suppression</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/oncotype-dx' target='_blank'>Breastcancer.org: Oncotype DX</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05896189

Computer Games to Improve Thinking for People with Stage I-III Breast Cancer

Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial Scientific Title

Purpose

To study how well computer games improve thinking problems.

Who is this for?

People with stage I, stage II, or stage III breast cancer who have completed treatment 6 months to 5 years ago. You must be experiencing problems thinking. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Computer games designed to improve thinking skills</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 9 months</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General computer games</li> <li class="seamTextUnorderedListItem">Questionnaires, 2 times in 9 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognition is your ability to think.</li> <li class="seamTextUnorderedListItem">Problems with thinking, called cognitive impairment, can happen during and after breast cancer treatment.</li> <li class="seamTextUnorderedListItem">These problems can last for years and can affect a person's ability to work or participate in social activities.</li> <li class="seamTextUnorderedListItem">The computer games may help re-organize the connections of nerve cells in the brain to improve thinking ability.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05896189' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05929768

Shorter Chemotherapy and Immunotherapy Treatment Before Surgery for Stage I-III Triple Negative Breast Cancer

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of shorter chemotherapy and immunotherapy treatment without doxorubicin (Adriamycin®) chemotherapy before surgery (neoadjuvant).

Who is this for?

People with stage I, stage II, or some stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Carboplatin®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, before and/or after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, before and/or after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), carboplatin (Paraplatin®), paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Shorter chemotherapy treatment without doxorubicin (Adriamycin®) chemotherapy may work the same as usual chemotherapy treatment for stage I-III triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05929768' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
Zuckerberg San Francisco General
San Francisco,CA

VISITS: 8 visits within 3 months

PHASE: NA

NCT ID: NCT06055803

HEART-ACT Program to Improve Heart Health After Breast Cancer Treatment

The Heart Health After Cancer Treatment (HEART-ACT): A Pilot Study of a Multi-disciplinary Health Behavior Intervention in People With a History of Breast Cancer to Reduce Heart Disease Risk After Cancer Treatment. Scientific Title

Purpose

To study the ability of HEART-ACT, a health behavior program, to reduce heart disease risk after breast cancer treatment.

Who is this for?

People who have stage I, stage II, or stage III breast cancer who have completed treatment. You must have received care at Zuckerberg San Francisco General Hospital. Full eligibility criteria

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You will receive the following as part of the HEART-ACT program: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Visit to create individualized plan and goals</li> <li class="seamTextUnorderedListItem">Health behavior sessions, 3 months</li> <li class="seamTextUnorderedListItem">Exercise program, 3 months</li> <li class="seamTextUnorderedListItem">Fitness tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">The HEART-ACT program covers physical activity, nutrition, emotional well-being, cardiovascular risk, survivorship, and personalized topics such as stopping smoking.</li> <li class="seamTextUnorderedListItem">The program will alternate each week between group and individual sessions and in-person and virtual sessions.</li> <li class="seamTextUnorderedListItem">Individual sessions will be led by a health promotion specialist (nurse or exercise physiologist). These sessions include reviewing goals and making a plan for the next 2 weeks.</li> <li class="seamTextUnorderedListItem">Participants will exercise as part of individual and group sessions. Participants will also be asked to exercise on their own, with a goal of working up to 2.5 hours each week of exercise and 2 strength training sessions.</li> <li class="seamTextUnorderedListItem">At the end of the program, there will be a graduation session to honor the participant's achievement and establish a plan for maintenance after the program.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish and Cantonese.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06055803' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://heartact.ucsf.edu/' target='_blank'>University of California San Francisco: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/breast-cancer/heart-health-breast-cancer-treatment' target='_blank'>WebMD: Heart Health After Breast Cancer Treatment</a> </li></ul>

NEAREST SITE: 3 miles
Berkeley Outpatient Center
Berkeley,CA

VISITS: 1 visit every 6 months for 5 years

PHASE: II

NCT ID: NCT06075953

Hormone Therapy and Active Surveillance for Women with HR+ DCIS

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study Scientific Title

Purpose

To study if hormone therapy and active monitoring (MRIs and mammograms) is an effective way to treat and manage DCIS.

Who is this for?

Women with stage 0 (DCIS) hormone receptor positive (ER+ and/or PR+) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy (standard of care or experimental) for 6 months</li> <li class="seamTextUnorderedListItem">MRI scans, 2 times within 6 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery (if needed)</li> </ul> or: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue on hormone therapy for 2-5 years</li> <li class="seamTextUnorderedListItem">Alternating MRI scan or mammogram every 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">After evaluation at 6 months, participants will either have surgery (if recommended) or continue on the treatment for 2-5 years.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">(Z)-endoxifen is similar to tamoxifen.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs work by blocking the activity of estrogen in people with mutations in the ESR1 gene.</li> <li class="seamTextUnorderedListItem">Testosterone is a hormone that may reduce the risk of breast cancer.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A mammogram is a breast cancer screening procedure involving taking an x-ray picture of the breast.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06075953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quantumleaphealth.org/portfolio/dcis' target='_blank'>Quantum Leap Healthcare Collaborative: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/ductal-carcinoma-in-situ' target='_blank'>Breastcancer.org: DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT06157892

Disitamab Vedotin Antibody Drug Conjugate for Advanced HER2 Low or HER2+ Breast Cancer

A Phase 1b/2 Open-Label Study of Disitamab Vedotin Monotherapy or in Combination With Other Anticancer Therapies in Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of disitamab vedotin, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 low or HER2 positive (HER2+) breast cancer who have received trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in disitamab vedotin targets HER2 proteins. It delivers the chemotherapy MMAE.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06157892' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/technologies' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/technologies' target='_blank'>Seagen: ADC Information Page</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06177171

ASTX727 Targeted Therapy with Olaparib for Advanced Breast Cancer with Certain Mutations

A Phase I/Ib Study of Olaparib and ASTX727 in BRCA1/2- and HRD-mutated Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ASTX727, an experimental targeted therapy, with olaparib (Lynparza®) PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with BRCA1, BRCA2, PALB2, ATM, and/or CHEK2 inherited or tumor mutations who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ASTX727, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ASTX727 is an experimental targeted therapy called a DNMT inhibitor. Blocking DNMT may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">ASTX727 is a combination of decitabine with cedazuridine.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">BRCA1, BRCA2, PALB2, ATM, and CHEK2 gene mutations are homologous recombination repair (HRR) or homologous recombination deficient (HRD) mutations.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06177171' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/oral-decitabine-and-cedazuridine-astx727-hematological-malignancies/' target='_blank'>Astex Pharmaceuticals: ASTX727 Drug Information Page</a> </li></ul>

NEAREST SITE: 3 miles
UCSF
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT06188559

BB-1701 Antibody Drug Conjugate for Advanced HER2+ or HER2 Low Breast Cancer

An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an Anti-human Epidermal Growth Factor Receptor 2 (Anti-HER2) Antibody-drug Conjugate (ADC), in Previously Treated Subjects With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BB-1701, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received trastuzumab deruxtecan (Enhertu®). You must have received 1-3 lines of chemotherapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BB-1701, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BB-1701 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BB-1701's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called eribulin.</li> <li class="seamTextUnorderedListItem">In this trial, HER2+ is defined as IHC 3+ or IHC 2+/ISH+.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/ISH -.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06188559' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.blissbiopharma.com/Innovation?_l=en#Pipeline' target='_blank'>Eisai/Bliss Biopharmaceutical: BB-1701 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT06215469

Portable Scalp Cooling System to Reduce Hair Loss During Chemotherapy for Stage I-III Breast Cancer

Amma™ Portable Scalp Cooling System (PSCS) Study: A Post-market Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Early-stage Breast Cancer (Cooler Heads) Scientific Title

Purpose

To study the ability of the AMMA Portable Scalp Cooling System to reduce hair loss in people receiving chemotherapy.

Who is this for?

People with stage I, stage II, or stage III breast cancer who are planning to receive paclitaxel (Taxol®) or docetaxel (Taxotere®) chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Photographs of your hair</li> <li class="seamTextUnorderedListItem">Wear the AMMA Portable Scalp Cooling System 30 minutes before, during, and 2.5 hours after every chemotherapy visit</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Photographs of your hair</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many chemotherapy medications cause hair loss.</li> <li class="seamTextUnorderedListItem">The AMMA Portable Scalp Cooling System is a small refrigeration device that is designed to reduce hair loss. It circulates liquid coolant at low pressure through a cooling cap on your head.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06215469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://coolerheads.com/#how-amma-works' target='_blank'>Amma Portable Scalp Cooling System</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT06253130

IMP1734 PARP Inhibitor for Advanced Breast Cancer

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMP1734, an experimental PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received chemotherapy and 0-1 lines of a PARP inhibitor. You must have a BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253130' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.eikontx.com/#pipeline' target='_blank'>Eikon Therapeutics: IMP1734/EIK1003 Drug Information Page</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06264921

NKT3447 CDK2 Inhibitor for Advanced Triple Negative or HR+, HER2- Breast Cancer

A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Orally Available CDK2 Inhibitor NKT3447 in Adults With Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of NKT3447, an experimental CDK2 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3447, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3447 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06264921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nikangtx.com/science-and-pipeline/' target='_blank'>NiKang Therapeutics: NKT3447 Drug Information Page</a> </li></ul>

NEAREST SITE: 5 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05315700

ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer

An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ORIC-114, an experimental x, alone or with chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and/or pemetrexed (Alimta®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114 is an experimental anti-HER2 targeted therapy and blocks EGFR and HER2. Blocking EGFR and HER2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and pemetrexed (Alimta®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05315700' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://oricpharma.com/pipeline/#oric114' target='_blank'>ORIC Pharmaceuticals: ORIC-114 Drug Information Page</a> </li></ul>

NEAREST SITE: 5 miles
University of California, San Francisco
San Francisco,CA

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT05964504

PLUMB Registry for Metastatic Lobular Breast Cancer

Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer Scientific Title

Purpose

To create a registry to study metastatic lobular breast cancer, treatment patterns, and overall survival.

Who is this for?

People with stage IV (metastatic) lobular breast cancer. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples will be used to study the relationship between ctDNA and disease progression.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">This trial will also develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05964504' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT05964504' target='_blank'>University of California, San Francisco: Trial Information Page</a> </li></ul>

NEAREST SITE: 6 miles
Cedars-Sinai
Los Angeles,CA

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT05720039

Nipple Sparing Mastectomy with da Vinci SP Surgical System for Women with Stage I-III Breast Cancer

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SPâ„¢ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of robotic-assisted nipple sparing mastectomy with da Vinci SP Surgical System, an experimental surgery system.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are planning to receive a nipple sparing mastectomy with immediate reconstruction. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Robotic-assisted nipple sparing mastectomy with da Vinci single port (SP) Surgical System</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Open nipple sparing mastectomy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A mastectomy is surgery to remove a breast.</li> <li class="seamTextUnorderedListItem">A nipple sparing mastectomy (NSM) leaves most of the healthy breast skin, including the nipple.</li> <li class="seamTextUnorderedListItem">The da Vinci single port (SP) Surgical System is an experimental surgery system designed for surgeons to perform minimally invasive surgery, such as nipple sparing mastectomy.</li> <li class="seamTextUnorderedListItem"> Your surgeon performs the surgery using the da Vinci SP Surgical System.</li> <li class="seamTextUnorderedListItem">The da Vinci SP Surgical System is approved for use during other surgeries.</li> <li class="seamTextUnorderedListItem">Robotic-assisted NSM with da Vinci SP Surgical System may be less invasive than standard of care open NSM.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05720039' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.intuitive.com/en-us/patients/da-vinci-robotic-surgery/about-the-systems' target='_blank'>Intuitive Surgical Device Information Page: About the Da Vinci Surgical System</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/health-library/diseases-and-conditions/n/nipple-sparing-mastectomy.html' target='_blank'>Cedars-Sinai: Nipple Sparing Mastectomy</a> </li></ul>

NEAREST SITE: 7 miles
xCures
Oakland,CA

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT05461430

Malignant Fluid Test to Predict Response to Treatment for Breast Cancer

Mass Response of Malignant Fluid Cells as a Biomarker for Rapid Therapy Guidance Scientific Title

Purpose

To study if a mass response test can predict your cancer's response to potential treatments.

Who is this for?

People with stage I, stage II, stage III, or metastatic (stage IV) breast cancer that have malignant fluid. Full eligibility criteria

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Additional malignant fluid will be collected as part of a standard of care procedure.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Malignant fluid is the build up of fluid and cancer cells in your body.</li> <li class="seamTextUnorderedListItem">A cancer cell's mass response (weight change) indicates when a cancer cell begins responding to a drug before it dies.</li> <li class="seamTextUnorderedListItem">The results from the mass response test may be used by your doctor to choose your next treatment(s).</li> <li class="seamTextUnorderedListItem">Additional malignant fluid will be collected as part of a standard of care procedure.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05461430' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.travera.com/clinical-study-summary' target='_blank'>Travera Trial Information Page: TRV-003</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.travera.com/technology' target='_blank'>Travera: Mass Response Test</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thoracic.org/patients/patient-resources/resources/malignant-pleural-effusions.pdf' target='_blank'>American Thoracic Society: Malignant Fluid</a> </li></ul>

NEAREST SITE: 8 miles
Kaiser Permanente Cancer Treatment Center
South San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03488693

Radiation or No Radiation to Treat Low Risk Node Positive Breast Cancer

TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (TAILOR RT) Scientific Title

Purpose

To compare the effects (good and bad) of radiation therapy to no radiation therapy in patients with low-risk breast cancer who have had surgery.

Who is this for?

Women with early stage (stage I, II or IIIa) breast cancer who has been treated with breast cancer surgery and has an Oncotype DX recurrence score less than 18. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation (following breast surgery)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation (following breast surgery)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation is given to reduce the risk of the cancer coming back in the breast. </li> <li class="seamTextUnorderedListItem">It is not known if radiation therapy after surgery improves outcomes in women with low-risk breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03488693' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/SideEffectsofRadiationTherapy.html' target='_blank'>Susan G. Komen: Side Effects of Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.eortc.org/blog/2018/03/23/many-women-with-early-breast-cancer-have-a-very-low-risk-of-a-locoregional-recurrence-five-years-after-surgery/' target='_blank'>European Organisation for Research and Treatment of Cancer: Many women with early breast cancer have a very low risk of a locoregional recurrence 5 years after surgery</a> </li></ul>

NEAREST SITE: 8 miles
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03723928

Imaging and Tumor Mark Tests to Monitor Metastatic HR Positive, HER2 Negative Breast Cancer

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer (SWOG-S1703) Scientific Title

Purpose

To study if blood tests that look for tumor markers are as good as or better than imaging with PET and/or CT scans (the current standard of care) to determine if a tumor is growing.

Who is this for?

People with metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to have first line treatment for metastatic disease or have started treatment within the past month, and have at least one elevated tumor marker. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging (CT and/or PET scans), at least every 3 months, ongoing</li> <li class="seamTextUnorderedListItem">Tumor Marker Test, if ordered by your doctor</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Marker Tests, every 1 to 2 months, ongoing</li> <li class="seamTextUnorderedListItem">Imaging (CT and/or PET scans), only if need is shown by a Tumor Marker Test</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This imaging trial will compare using blood tests to PET/CT scans for monitoring tumor growth. </li> <li class="seamTextUnorderedListItem">The tumor markers that will be tested for in this study are CA 15-3, CA27.29, and CEA.</li> <li class="seamTextUnorderedListItem">The imaging tests will be those ordered by your doctor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03723928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/blood_marker' target='_blank'>Breastcancer.org: Blood Marker Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/about-us/collaborations/top-five-list-oncology/choosing-wisely®-top-five-cancer-related-tests-procedures-and-treatments-many-patients-do-not-need/topic-4-follow-tumor-marker-tests-and-imaging-tests-people-treated-breast-cancer' target='_blank'>ASCO Cancer.net: Follow-up Tumor Marker Tests and Imaging Tests for People Treated for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis/tumor-markers-fact-sheet' target='_blank'>NCI: Tumor Markers</a> </li><li class='seamTextUnorderedListItem'><a href='https://ozarkscancerresearch.org/wp-content/uploads/2019/04/SWOG-S1703.pdf' target='_blank'>Cancer Research for the Ozarks: Trial Information Page</a> </li></ul>

NEAREST SITE: 8 miles
Bay Area Breast Surgeons Inc
Emeryville,CA

VISITS: 1 visit every week (2 weeks on, 1 week off), ongoing

PHASE: II

NCT ID: NCT04647916

Sacituzumab Govitecan for HER2 Negative Breast Cancer Brain Metastases

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease, but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04647916' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/sacituzumab-govitecan-shows-pfs-benefit-for-patients-with-mtnbc-and-brain-metastases' target='_blank'>Targeted Oncology: Sacituzumab Govitecan Shows PFS Benefit for Patients With mTNBC and Brain Metastases</a> </li></ul>

NEAREST SITE: 8 miles
Bay Area Breast Surgeons Inc
Emeryville,CA

VISITS: 2 visits in 1 year

PHASE: NA

NCT ID: NCT05334069

Collecting Blood Samples From People With and Without Breast Cancer to Evaluate Tests for Early Cancer Detection

Blinded Reference Set for Multicancer Early Detection Blood Tests Scientific Title

Purpose

To collect blood and tissue samples from people with breast cancer and people without breast cancer to evaluate tests for early cancer detection.

Who is this for?

People 40-75 years old with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who have not yet received treatment, or who do not have breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide blood samples, 2 times</li> <li class="seamTextUnorderedListItem">Provide tissue samples (for people with cancer), 2 times</li> <li class="seamTextUnorderedListItem">Complete questionnaires, 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collecting and storing samples of blood and tissue from patients with and without breast cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05334069' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis' target='_blank'>National Cancer Institute: How Cancer Is Diagnosed</a> </li></ul>

NEAREST SITE: 10 miles
Alta Bates Summit Medical Center; Comprehensive Cancer Center
Berkeley,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05306340

Hormone Therapy and Targeted Therapy for ER+, HER2- Advanced Breast Cancer

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus in Patients With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, with targeted therapy compared to an aromatase inhibitor with targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with hormone therapy in combination with a CDK 4/6 inhibitor. You must not have received more than 2 lines of hormone therapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash, 4 times daily for at least 8 weeks</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash, 4 times daily for at least 8 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash is an anti-inflammatory medication used to prevent and treat side effects of some cancer drugs.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05306340' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care, Inc
Greenbrae,CA

VISITS: 1 visit every 3 months, for 13 months

PHASE: III

NCT ID: NCT04906395

Experimental Ovarian Suppression Therapy Every 3 Months for Premenopausal Women and Men with Stage I-III Hormone-Positive Breast Cancer

Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Scientific Title

Purpose

To study the safety and effectiveness of an experimental ovarian suppression drug that is given every 3 months.

Who is this for?

People aged 18 to 55 with stage I, stage II, or stage III hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer who have not yet started anti-hormone therapy. If you are a woman, you must be premenopausal to enroll. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide acetate, by injection, every 3 months, for 1 year</li> <li class="seamTextUnorderedListItem">Your doctor's choice of tamoxifen or an aromatase inhibitor, by mouth, daily, for 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide acetate is a type of hormone therapy called a <q>luteinizing hormone-releasing hormone</q> (LHRH) agonist. It is approved for use in people with prostate cancer, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Leuprolide acetate is being used in this trial to suppress ovarian function (induce menopause) in women who are premenopausal.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04906395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/guidelines-on-ovary-suppression-for-early-HR-pos' target='_blank'>Breastcancer.org: ASCO Updates Guidelines on Ovarian Suppression</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/10.1200/JCO.2006.07.2397' target='_blank'>Journal Article: Leuprolide Acetate Plus Aromatase Inhibition for Male Breast Cancer</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care Inc
Greenbrae,CA

VISITS: 2 visits for 1 month, then 1 visit every month

PHASE: III

NCT ID: NCT05646862

Targeted Therapy with Fulvestrant for HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combinatio... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with fulvestrant (Faslodex®) hormone therapy compared to alpelisib (Piqray®) PI3K inhibitor with fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation. You must have received treatment with a CDK 4/6 inhibitor with hormone therapy as 1 of up to 2 lines of therapy for advanced/metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), every 2 weeks for 1 month, then monthly</li> </ul> Group 2: Standard Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05646862' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 15 miles
Research Site
Greenbrae,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05774951

CAMBRIA-1: Camizestrant After At Least 2 Years of Hormone Therapy for Stage I-III ER+, HER2- Breast Cancer

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of camizestrant, an experimental hormone therapy, compared to standard of care hormone therapy.

Who is this for?

People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with high or intermediate risk of recurrence. You must have received surgery and 2 to 5 years of hormone therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant, by mouth, for 5 years</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), anastrozole (Arimidex®), or tamoxifen (Nolvadex®), by mouth, for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05774951' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care Inc
Greenbrae,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06065748

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, compared with fulvestrant (Faslodex®) hormone therapy in combination with a CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who not have received treatment (except for surgery or radiation) for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and giredestrant are a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental SERD.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">The FoundationOne Liquid CDx Assay blood test will identify ctDNA mutations.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06065748' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html#:~:text=This%20compound%20and%20its%20use,US%20Food%20and%20Drug%20Administration.' target='_blank'>Genentech: Giredestrant Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03418961

Carvedilol to Prevent Heart Problems in People with Metastatic HER2+ Breast Cancer

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III Scientific Title

Purpose

To investigate whether a beta-blocker can help prevent heart problems caused by cancer treatments.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who are receiving or planning to receive trastuzumab (Herceptin®). Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvedilol, by mouth, daily for up to 2 years</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No intervention</li> </ul> Group 3: If you are already taking taking a beta blocker, ARB, or ACE inhibitor <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation for up to 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">The beta-blocker being used in this study is carvedilol. It is used to treat heart failure and high blood pressure.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03418961' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/side_effects/heart_probs' target='_blank'>Breastcancer.org: Heart Problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.health.harvard.edu/heart-health/treatments-for-breast-cancer-may-harm-the-heart' target='_blank'>Harvard Health Publishing: Treatments for Breast Cancer</a> </li></ul>

NEAREST SITE: 22 miles
Redwood City
Redwood City,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05059444

ctDNA Test to Detect Breast Cancer That Has Come Back or Remains After Treatment

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE) Scientific Title

Purpose

To study the ability of Guardant Reveal, a new blood test, to detect residual disease and recurrence after treatment.

Who is this for?

People with stage I, stage II, or stage III breast cancer who have residual disease (leftover cancer cells in your breast or lymph node) after chemotherapy and surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">Guardant Reveal is a new test that detects ctDNA in blood.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</li> <li class="seamTextUnorderedListItem">Recurrence refers to cancer that has come back after treatment.</li> <li class="seamTextUnorderedListItem">This study is enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05059444' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>MedLine Plus: What is ctDNA?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.guardanthealthamea.com/guardant-reveal/' target='_blank'>Guardant Health: The Guardant Reveal ctDNA Test</a> </li></ul>

NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06112613

Mobile Health Tools to Help Take Medication as Prescribed for People with Metastatic Breast Cancer

Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP) Scientific Title

Purpose

To study if WiseBag and CONCURxP mobile health tools will improve the ability of people to take their medication as prescribed compared to WiseBag alone.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive a CDK4/6 inhibitor or started receiving a CDK4/6 inhibitor within the past month. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Enhanced Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WiseBag, 1 year</li> <li class="seamTextUnorderedListItem">Educational materials, monthly for 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 1 year</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WiseBag, 1 year</li> <li class="seamTextUnorderedListItem">CONCURxP, 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 1 year</li> <li class="seamTextUnorderedListItem">Interviews, 6 months after completing study</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors need to be taken as prescribed to receive the best benefit.</li> <li class="seamTextUnorderedListItem">Using WiseBag and CONCURxP may reduce forgetfulness for taking medications.</li> <li class="seamTextUnorderedListItem">WiseBag is a lunch box sized medication monitoring device that holds and monitors medications.</li> <li class="seamTextUnorderedListItem">The CONnected CUstomized Treatment Platform (CONCURxP) includes personalized text message reminders for missed medications, monitoring of the medications you take, and notifications to doctors about missed doses.</li> <li class="seamTextUnorderedListItem">CONCURxP sends a text message when a medication is not taken when it should be.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06112613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/staying-on-track-with-treatment' target='_blank'>Breastcancer.org: Following Your Treatment Plan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 23 miles
John Muir Medical Center-Walnut Creek
Walnut Creek,CA

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT01570998

Targeted Intraoperative Radiotherapy (TARGIT) Registry Trial

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery Scientific Title

Purpose

To study the effects (good and bad) of targeted intraoperative radiotherapy.

Who is this for?

Women 45 and older, with stage I or stage II estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who will have a lumpectomy (breast conserving surgery) and are considered low risk for a local recurrence. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiotherapy as a single dose after breast conserving surgery (lumpectomy)</li> </ul> Participants may receive whole breast radiation, if indicated.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation is used to kill any breast cancer cells that may not have been removed during surgery.</li> <li class="seamTextUnorderedListItem">Targeted intraoperative radiotherapy is delivered during surgery immediately after the tumor has been removed. This allows the radiation to accurately target the tissue surrounding the tumor, where the risk of recurrence is highest.</li> <li class="seamTextUnorderedListItem">It takes about 20-35 minutes to provide intraoperative radiotherapy.</li> <li class="seamTextUnorderedListItem">The Targeted Intraoperative Radiotherapy Trial (TARGIT), will follow women who receive this type of radiation therapy for five years, allowing researchers to study its effectiveness and side effects.</li> <li class="seamTextUnorderedListItem">If indicated, you will also receive whole breast radiation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01570998' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation/intraoperative' target='_blank'>Breastcancer.org: Intraoperative Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://scholar.google.com/scholar?q=intraoperative+radiation+therapy+breast+cancer&hl=en&as_sdt=0&as_vis=1&oi=scholart&sa=X&ei=V-NpUMOGOObmiwKC2IHQDg&ved=0CCkQgQMwAA' target='_blank'>Google Scholar: Intraoperative Radiation Therapy Breast Cancer</a> </li></ul>

NEAREST SITE: 23 miles
Research Site
Walnut Creek,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05952557

Camizestrant Hormone Therapy for Stage I-III ER+, HER2- Breast Cancer

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of camizestrant, an experimental hormone therapy, compared to standard of care hormone therapy.

Who is this for?

People with stage I, stage II, or some stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received surgery less than 1 year ago and have completed standard treatment. You must not have received fulvestrant (Faslodex®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy: Exemestane (Aromasin®), letrozole (Femara®), anastrozole (Arimidex®), or tamoxifen (Nolvadex®)</li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth </li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05952557' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.goodrx.com/conditions/breast-cancer/oral-serd' target='_blank'>GoodRX: What is a SERD?</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University School of Medicine
Stanford,CA

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01034033

A Study of How Cancer Develops in Women With BRCA1/2 or Other Genetic Mutations

Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples Scientific Title

Purpose

To analyze blood samples from women at high risk of developing breast cancer in order to learn more about how cells change over time from normal to cancerous.

Who is this for?

Women at high-risk for developing breast cancer. Full eligibility criteria

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All participants will provide blood samples.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BRCA1 and BRCA2 are tumor suppressor genes.</li> <li class="seamTextUnorderedListItem">Inheriting a mutation in the BRCA1 or BRCA2 gene increases cancer risk. </li> <li class="seamTextUnorderedListItem">For the cancer to develop, though, the cells will need to first acquire other mutations.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01034033' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://stanfordhealthcare.org/medical-conditions/cancer/hboc/brca-1-and-2.html' target='_blank'>Stanford: About Hereditary Breast Ovarian Cancer Syndrome</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT01034033?term=NCT01034033&rank=1' target='_blank'>ClinicalTrials.gov trial info</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University
Stanford,CA

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT04282044

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving an experimental immunotherapy made from cells from your own immune system.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make the immunotherapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">CRX100, by IV</li> </ul> A hospital stay may be required
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CRX100 is the name of the immunotherapy used in this trial. It may work by directly killing cancer cells and by getting the immune system to go after and kill cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04282044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bioeclipse.com/clinical-trials-overview/' target='_blank'>BioEclipse Therapeutics Drug Information Page: CRX1000</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/25381063/' target='_blank'>Journal Article Abstract: Cytokine-Induced Killer (CIK) Cells in Cancer Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University School of Medicine
Stanford,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04300556

Experimental Antibody-Drug Conjugate MORAb-202 for Women with Metastatic Triple Negative Breast Cancer that Tests Positive for FRA

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRÎ±)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving the experimental antibody-drug conjugate MORAb-202.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have already received a platinum-based chemotherapy and whose tumor tests positive for FRA. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MORAb-202, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells. Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">MORAb-202 is an experimental ADC. </li> <li class="seamTextUnorderedListItem">Its antibody targets FAR, a protein, and it delivers an anti-cancer drug called eribulin mesylate.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling women with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: FRA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04300556' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.5544' target='_blank'>Journal Article Abstract: MORAb-202</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04756765

Talazoparib PARP Inhibitor for Advanced Breast Cancer with a PALB2 Mutation

A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of talazoparib (Talzenna®) PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a PALB2 mutation who have received 0-3 treatments for advanced/metastatic disease. You must not have a BRCA1/2 mutation or received treatment with a PARP inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04756765' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Cancer Institute
Palo Alto,CA

VISITS: 1 visit per month

PHASE: II

NCT ID: NCT05305365

QBS72S Chemotherapy for Metastatic Triple Negative Breast Cancer with Brain or Leptomeningeal Metastasis

A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of QBS72S, an experimental chemotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) or leptomeningeal metastasis visible on an MRI who have received chemotherapy. If you have brain metastasis, you must have at least 1 lesion that has not received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S, by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S is an experimental chemotherapy that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastasis (LM) is when cancer has spread to the leptomeninges, also called leptomeningeal carcinomatosis, leptomeningeal disease (LMD), leptomeningeal cancer, neoplastic meningitis, meningeal metastasis, and meningeal carcinomatosis, among other names.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305365' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quadrigabiosciences.com/science/' target='_blank'>Quadriga Biosciences: QBS72S Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University Medical Center
Stanford,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05514717

XMT-2056 ADC for Advanced HER2+ or HER2 Mutated Breast Cancer

A Phase 1, First in Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2 Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of XMT-2056, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer or breast cancer with a HER2 mutation who have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">XMT-2056's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called Immunosynthen.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05514717' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/pipeline/overview/' target='_blank'>Mersana Therapeutics Drug Information Page: XMT-2056</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/about-adcs/' target='_blank'>Mersana Therapeutics: About ADCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/immunosynthen/' target='_blank'>Mersana Therapeutics: Immunosynthen</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

NEAREST SITE: 28 miles
Kaiser Permanente - Northern California
Vallejo,CA

VISITS: Please contact research site

PHASE: NA

NCT ID: NCT03061305

Molecular Profiling to Select Treatment for Advanced Breast Cancer

Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection (STRATA) Scientific Title

Purpose

To conduct a test of your tumor to determine if there are approved therapies or clinical trials targeting the mutations or biomarkers found in your tumor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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Molecular profiling will be done on your tumor sample at no cost.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A sample of your tumor will be tested for certain mutations and biomarkers. </li> <li class="seamTextUnorderedListItem">Your doctor will be told if there are treatments or clinical trials available for people with the mutations or biomarkers found in your tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03061305' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/broad-molecular-profiling-tests' target='_blank'>Breastcancer.org: Broad Molecular Profiling Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://unclineberger.org/research/octr/our-research/strata-trial' target='_blank'>UNC Lineberger Comprehensive Cancer Center: Study website</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Stanford,CA

VISITS: Daily visits for 5 days, followed by surgery

PHASE: NA

NCT ID: NCT03909282

Radiation Therapy Before Surgery For DCIS

A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS) Scientific Title

Purpose

To look at the effect radiation therapy has on DCIS cancer cells and surrounding tissue when it is given before surgery.

Who is this for?

Women with ductal carcinoma in situ (DCIS) who has not yet started cancer treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Partial breast irradiation, once a day for 5 days, before surgery</li> <li class="seamTextUnorderedListItem">Lumpectomy or mastectomy</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lumpectomy or mastectomy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is looking at the effect radiation therapy has on DCIS cancer cells and surrounding tissue when it is given before surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03909282' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/dcis/treatment?gclid=EAIaIQobChMIyOnukvrn5QIVoxx9Ch1_pgdEEAAYAiAAEgIxZvD_BwE' target='_blank'>Breastcancer.org: Treatment for DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/rads-after-sx-for-dcis-reduces-recurrence-risk' target='_blank'>Breastcancer.org: Radiation Therapy After Surgery for Low-Risk DCIS Reduces Recurrence Risk</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Palo Alto,CA

VISITS: 1 visit per week, ongoing

PHASE: I-II

NCT ID: NCT04092673

eFT226 in Advanced Breast Cancer That Tests Positive for HER2, ERBB3, FGFR1, FGFR2, or KRAS Mutations

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of eFT226 (Zotatifin), an experimental targeted therapy that blocks eIF4A1.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has been treated with standard therapies and tests positive for a mutation in HER2 (ERRB2), ERBB3, FGFR1, FGFR2, or KRAS. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">eFT226 (Zotatifin), by IV, weekly, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">eFT226 (Zotatifin) is an experimental targeted therapy that blocks eIF4A1. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of solid tumors that have these mutations.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2 (ERBB2), ERBB3, FGFR1, FGFR2, or KRAS</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04092673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2019/11/05/1941103/0/en/eFFECTOR-Therapeutics-Initiates-Phase-1-2-Safety-and-Efficacy-Study-of-Zotatifin-eFT226-in-Patients-with-Advanced-Solid-Tumor-Malignancies.html' target='_blank'>Drug Company Press Release: eFT226 (Zotatifin)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Targeted Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/cddis2014542' target='_blank'>Journal Article: The Malignant Phenotype in Breast Cancer is Driven by eIF4A1-mediated Changes in The Translational Landscape</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Stanford,CA

VISITS: 2 visits within 6 months

PHASE: II

NCT ID: NCT04768426

ctDNA Monitoring During Chemotherapy for Stage I-III Triple Negative Breast Cancer

Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy Scientific Title

Purpose

To use circulating tumor DNA (ctDNA) to identify who will or will not experience benefit from adjuvant (after surgery) capecitabine (Xeloda®) chemotherapy.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have residual disease after neoadjuvant (before surgery) chemotherapy and surgery. You must be planning to receive capecitabine (Xeloda®) after surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> <li class="seamTextUnorderedListItem">Blood test, 2 times within 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">ctDNA tests are also called liquid biopsies.</li> <li class="seamTextUnorderedListItem">In this study, changes in ctDNA in the blood will be monitored over time during capecitabine (Xeloda®) treatment and related to genetic mutations in tumors. </li> <li class="seamTextUnorderedListItem">Results from this study may provide information for future clinical trials in which patients receive a different treatment than capecitabine (Xeloda®) to reduce their risk of breast cancer coming back (recurrence).</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04768426' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 28 miles
Kaiser Permanente - Vallejo
Vallejo,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04961996

Giredestrant Adjuvant Therapy for Stage I-III ER+, HER2- Breast Cancer

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, after surgery (adjuvant therapy).

Who is this for?

People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who are planning to receive hormone therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily for 5 years</li> </ul> Group 2: Standard Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of aromatase inhibitor or tamoxifen, by mouth, daily for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adjuvant therapy is treatment given after surgery for stage I, stage II, or stage III breast cancer to prevent cancer from returning.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04961996' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Cancer Institute
Palo Alto,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05082610

HMBD-002 Immunotherapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of HMBD-002, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) PD-L1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002, by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002 is an experimental immunotherapy that targets a protein called VISTA and may increase the immune system's ability to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05082610' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://hummingbirdbioscience.com/hmbd-002/' target='_blank'>Hummingbird Bioscience: HMBD-002 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.precisiononcologynews.com/cancer/hummingbird-bioscience-merck-study-hmbd-002-keytruda-various-solid-tumors' target='_blank'>Precision Oncology News: HMBD-002</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Cancer Institute Palo Alto
Palo Alto,CA

VISITS: 2 visits within 1 month including surgery; may require hospitalization

PHASE: III

NCT ID: NCT05438212

Radiation Before or After Surgery for Brain Metastasis

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of stereotactic radiosurgery (radiation) before and after surgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive brain surgery. You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li> </ul> followed 10-30 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 1 time</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery, 1 time</li> </ul> followed up to 7 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove brain tumor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05438212' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 28 miles
Kaiser Permanente Medical Center - Vallejo
Vallejo,CA

VISITS: 1-3 visits per month

PHASE: III

NCT ID: NCT05501886

Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental pan-PI3K and mTOR inhibitor, with fulvestrant (Faslodex®) hormone therapy, with or without palbociclib (Ibrance®) CDK 4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with or without a PIK3CA mutation who have received treatment with a CDK 4/6 inhibitor with an aromatase inhibitor. You must not have received more than 1 chemotherapy for advanced disease or 2 lines of hormone therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups depending on your cancer: Group 1: Experimental, with or without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 2: Experimental, with or without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 3: Standard of Care, without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 4: Standard of Care, with PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K and mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501886' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity Drug Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Hospital and Clinics
Palo Alto,CA

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT05975359

Comparing Drains During Bilateral Mastectomy with Immediate Breast Reconstruction

A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction Scientific Title

Purpose

To compare the safety and effects (good and bad) of Interi Drains to standard of care Jackson-Pratt (JP) Drains during bilateral (both breast) mastectomy.

Who is this for?

Women 18-65 years old with stage I, stage II, or stage III breast cancer who are planning to receive a bilateral (both breasts) mastectomy with immediate reconstruction. Full eligibility criteria

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You will receive the following during surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Interi Drain on 1 breast</li> <li class="seamTextUnorderedListItem">Jackson-Pratt (JP) Drain on 1 breast</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Drain log, daily</li> <li class="seamTextUnorderedListItem">Drain removal, 1-3 weeks after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">During implant-based breast reconstruction, surgical drains are placed to prevent fluid build up.</li> <li class="seamTextUnorderedListItem">The most frequently used drain is a Jackson-Pratt (JP) Drain.</li> <li class="seamTextUnorderedListItem">The Interi Drain system may work better than the JP Drain system.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05975359' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 40 miles
Providence Queen of the Valley Medical Center
Napa,CA

VISITS: 1 visit every month

PHASE: III

NCT ID: NCT05654623

ARV-471 Hormone Therapy Compared to Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer

A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2) Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of ARV-471 (PF-07850327), an experimental hormone therapy, to fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received 1 line of treatment with a CDK inhibitor with hormone therapy and up to 1 additional line of hormone therapy for advanced disease. You must not have received chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 (PF-07850327), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 (PF-07850327) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05654623' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='www.veritac2study.com' target='_blank'>Pfizer: Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 47 miles
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04266249

Neoadjuvant (Before Surgery) Chemotherapy and Targeted Therapies for Stage II-III, HER2+ Breast Cancer

(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response (EA1181) Scientific Title

Purpose

To determine if chemotherapy after surgery can be avoided for people who have no tumor remaining after receiving chemotherapy and targeted therapy before surgery.

Who is this for?

People with stage II or stage III, HER2 positive (HER2+) breast cancer. Full eligibility criteria

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Before surgery, you will receive the following, for 3 months: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, either once a week or every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every week (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, once every 3 weeks</li> </ul> Followed by surgery (lumpectomy or mastectomy) After surgery, you will be assigned to 1 of 2 groups depending upon if you had any tumor remaining: Group 1: No tumor remaining <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, once every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Pertuzumab, (Perjeta®), by IV, once every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Radiation therapy and/or hormone therapy</li> </ul> Group 2: Tumor remaining <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, for 10 months</li> <li class="seamTextUnorderedListItem">Radiation therapy, hormone therapy and/or chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy and targeted therapy (treatment given before surgery) is used to shrink tumors.</li> <li class="seamTextUnorderedListItem">Sometimes the tumor will disappear completely and sometimes there will still be some tumor remaining at the time of surgery. </li> <li class="seamTextUnorderedListItem">Your doctor will decide which neoadjuvant chemotherapy to give you: docetaxel (Taxotere®), nab-paclitaxel (Abraxane®), or paclitaxel (Taxol®). </li> <li class="seamTextUnorderedListItem">Everyone will receive the same anti-HER2 targeted therapies of trastuzumab (Herceptin®) and pertuzumab (Perjeta®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04266249' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/clinical-trials/ea1181-educational-materials' target='_blank'>Cancer Research Group: CompassHER2 Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/health/breast-cancer/chemotherapy-for-her2-positive-breast-cancer#chemotherapy-side-effects' target='_blank'>Healthline: Chemotherapy and Targeted Therapy for HER2-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/her2' target='_blank'>Breastcancer.org: HER2 Status</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hematologyandoncology.net/archives/may-2019/how-we-treat-locally-advanced-her2-positive-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: How We Treat Locally Advanced HER2-Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://esmoopen.bmj.com/content/4/3/e000515' target='_blank'>Journal Article: Neoadjuvant Treatment for Intermediate/High-Risk HER2 Positive and Triple Negative Breast Cancers</a> </li></ul>

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05123482

AZD8205 for Advanced Triple Negative BreastCancer

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies Scientific Title

Purpose

To determine the safety, side effects, dose, and anti-cancer activity of AZD8205, and antibody-drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. You must not have received more than one line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8205, by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05123482' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 53 miles
Providence Medical Foundation
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05579366

PRO1184 Antibody Drug Conjugate for Advanced HER2- Breast Cancer that Expresses FRA

Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRO1184, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer that expresses folate receptor alpha (FRA) who have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRO1184, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRO1184 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BB-1701's antibody targets folate receptor alpha (FRA), a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called exatecan.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: FRA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05579366' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/profoundbio-receives-fda-study-may-proceed-letter-for-pro1184-a-folate-receptor-alpha-directed-adc-with-a-topoisomerase-1-inhibitor-payload-and-welcomes-naomi-hunder-md-as-chief-medical-officer-301598943.html?tc=em' target='_blank'>ProfoundBio Press Release: PRO1184</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

NEAREST SITE: 53 miles
Providence Medical Foundation - Santa Rosa, CA
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05696626

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lasofoxifene, an experimental hormone therapy, with abemaciclib (Verzenio®) CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received an aromatase inhibitor with palbociclib (Ibrance®) or ribociclib (Kisqali®) CDK4/6 inhibitor as your first line of hormone therapy for advanced disease. You must not have received more than 1 line of chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05696626' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://sermonixpharma.com/lasofoxifene/' target='_blank'>Sermonix Pharmaceuticals: Lasofoxifene Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06103864

Dato-DXd ADC With or Without Durvalumab Immunotherapy for Advanced Triple Negative, PD-L1 Positive Breast Cancer

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast (TROPION-Breast05) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan (Dato-DXd), an experimental antibody drug conjugate (ADC), with or without durvalumab immunotherapy compared to standard of care chemotherapy with pembrolizumab immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 positive breast cancer who have not yet received treatment for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Group 3: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are a type of immunotherapy called PD-1 inhibitors, which are a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, standard of care chemotherapy drugs include carboplatin (Paraplatin®), paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), and/or gemcitabine (Gemzar®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06103864' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D7630C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Datopotamab Deruxtecan (Dato-DXd)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/asco-2021/asco-2021-breast-cancer-in-depth/breast-cancer-durvalumab-neoadjuvant-chemo-treatment-risk/#:~:text=June%2024%2C%202021-,Durvalumab%20Improves%20Survival%20When%20Added%20to,in%2' target='_blank'>Cancer Therapy Advisor: Durvalumab (Imfinzi®)</a> </li></ul>

NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,CA

VISITS: Number of visits varies, ongoing

PHASE: II

NCT ID: NCT03606967

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of giving chemotherapy, the immunotherapy tremelimumab, and the PD-L1 inhibitor Durvalumab (Imfinzi®) together with or without a personalized synthetic long peptide (SLP) vaccine and Hiltonol® (poly-ICLC) .

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD-L1 negative and who have not yet received any treatment for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Vaccine <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized SLP Vaccine and Hiltonol® (poly-ICLC), 7 times over 2.5 months</li> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li> </ul> Group 2: No Vaccine <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of vaccine used in this trial is called a personalized synthetic long peptide (SLP) vaccine. It may help your immune system see and fight cancer cells. </li> <li class="seamTextUnorderedListItem">Hiltonol® (poly-ICLC) is an immune cell activating factor.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy routinely used to treat advanced and metastatic triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tremelimumab is a type of immunotherapy called a CTLA-4 inhibitor.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03606967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search/Personalized%20Synthetic%20Long%20Pe/?searchMode=Begins' target='_blank'>NCI Drug Dictionary: Personalized Synthetic Long Peptide Breast Cancer Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com' target='_blank'>Oncovir Drug Information Page: Hiltonol® (poly-ICLC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Tremelimumab' target='_blank'>Wikipedia: Tremelimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/durvalumab' target='_blank'>NCI Drug Dictionary: Durvalumab (Imfinzi®)</a> </li></ul>

100

NEAREST SITE: 74 miles
University of California Davis
Sacramento,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05208762

SGN-PDL1V Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of SGN-PDL1V, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Its antibody targets PD-1/PD-L1, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called vedotin.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05208762' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clinicaltrials.seagen.com/study/?pid=SGNPDL1V-001' target='_blank'>Seagen Trial Information Page: SGN-PDL1V</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.seagen.com/press-releases/news-details/2021/Seagen-to-Highlight-Two-Novel-Antibody-Drug-Conjugates-ADCs-at-the-SITC-36th-Annual-Meeting/default.aspx' target='_blank'>Seagen Press Release: SGN-PDL1V</a> </li></ul>

101

NEAREST SITE: 74 miles
University of California, Davis
Sacramento,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06103669

Adding Radiation to Treatment for People with Metastatic Oligoprogressive Breast Cancer

Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of adding radiation to metastatic breast cancer treatment.

Who is this for?

People with metastatic (stage IV) oligoprogressive breast cancer who have received at least 1 line of therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation or interventional radiology ablation</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Interventional radiology ablation uses heat or cold to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Oligoprogressive disease refers to progression of only a few sites of metastasis.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06103669' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://studypages.com/en/s/a-study-of-ablative-therapy-in-people-with-progressive-solid-tumors-valorous-278307/?ref=gallery' target='_blank'>University of California, Davis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.columbiaradiology.org/patients/services/interventional-radiology/tumor-ablation' target='_blank'>Columbia University: Interventional Radiology Ablation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/radiotherapy/external/types/stereotactic-body-radiotherapy-sbrt' target='_blank'>Cancer Research UK: Stereotactic Radiotherapy</a> </li></ul>

102

NEAREST SITE: 74 miles
University of California, Davis
Sacramento,CA

VISITS: 3 visits within 6 months

PHASE: NA

NCT ID: NCT06125145

Health Assessment and Coaching to Improve the Health of Older People With Breast Cancer

Tailored Geriatric Assessment and Promotores Pilot Feasibility Study (GAP) Scientific Title

Purpose

To study whether a program that assesses health and aging and provides coaching will address health issues in older adults with cancer.

Who is this for?

People 65-90 years old with stage II or stage III breast cancer that was diagnosed within the last 2 years who have completed treatment within the last year. You must have a caregiver 21-90 years old and live near Davis, California. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Assessment, 1 time</li> <li class="seamTextUnorderedListItem">Coaching, 45 minutes, 2 times</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Older adults with cancer often have other health issues that are not addressed after completing treatment.</li> <li class="seamTextUnorderedListItem">The assessment covers frailty (weakness), thinking ability, medications received, depression, symptoms, and social support.</li> <li class="seamTextUnorderedListItem">The coaching aims to provide social support and assist in adopting healthy behaviors.</li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06125145' target='_blank'>ClinicalTrials.gov</a> </li></ul>

103

NEAREST SITE: 164 miles
Community Cancer Institute
Clovis,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04895709

BMS-986340 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BMS-986340, an experimental CCR8 inhibitor, alone or with nivolumab (Opdivo®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. You must have received at least 1 PD-1 inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340 is an experimental immunotherapy called a CCR8 inhibitor. BMS-986340 blocks the activity of CCR8 on immune cells to activate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04895709' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bolderscience.com/trial/NCT04895709/' target='_blank'>Bristol-Myers Squibb: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bmsscience.com/?s=BMS-986340+%26plusmn%3B+Nivolumab&search_cat=bms' target='_blank'>Bristol-Myers Squibb: BMS-986340 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bms.com/assets/bms/us/en-us/pdf/CCR8-Immune-Pathway-Fact-Sheet.pdf' target='_blank'>Bristol-Myers Squibb: CCR8 Immune Pathway</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-ccr8-monoclonal-antibody-bms-986340?redirect=true' target='_blank'>National Cancer Institute: BMS-986340 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://chemocare.com/chemotherapy/drug-info/opdivo.aspx' target='_blank'>Chemocare: Nivolumab (Opdivo®)</a> </li></ul>

104

NEAREST SITE: 171 miles
Carson Tahoe Regional Medical Center
Carson City,NV

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT04314401

NCI Cancer Moonshot Biobank for Stage III-IV Breast Cancer

Cancer Moonshot Biobank Research Protocol Scientific Title

Purpose

To collect tissue samples, blood samples, and medical information from people with breast cancer to study how cancer changes over time and during treatment.

Who is this for?

People with stage III or stage IV (metastatic) breast cancer who are receiving or planning to receive treatment. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tissue and blood samples before, during, and after treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Collecting tissue samples, blood samples, and medical information over time may help researchers better understand resistance to treatment, changes in genes, and other factors about how cancer responds to treatment.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04314401' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moonshotbiobank.cancer.gov/' target='_blank'>National Cancer Institute: Cancer Moonshot Biobank</a> </li></ul>

105

NEAREST SITE: 182 miles
Cancer Care Specialists
Reno,NV

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06105632

PF-07220060 CDK4 Inhibitor with Fulvestrant Hormone Therapy for Advanced HR+, HER2- Breast Cancer

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PF-07220060, an experimental CDK4 inhibitor, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor with hormone therapy as the most recent line of therapy. You must not have received chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) and exemestane (Aromasin®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a CDK4 inhibitor. CDK4 is a protein that helps cancer grow. Blocking CDK4 helps slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06105632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06105632-advanced-or-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_04MAY2021.pdf?VersionId=.06Q_HtLdkBW8lme0Y3EXpraBpgGspyg' target='_blank'>Pfizer: PF-07220060 Drug Information Page</a> </li></ul>

106

NEAREST SITE: 198 miles
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
San Luis Obispo,CA

VISITS: 1 visit every 2-3 weeks

PHASE: III

NCT ID: NCT05382299

Sacituzumab Govitecan-hziy ADC for Advanced Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do E... (ASCENT-03) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan-hziy (Trodelvy®), a type of targeted therapy called an antibody drug conjugate (ADC), compared to chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and have not received treatment with sacituzumab govitecan-hziy (Trodelvy®). If your cancer is PD-L1 positive, you must have previously received treatment with a PD-1/PD-L1 inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) with carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05382299' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy#:~:text=Trodelvy%20(chemical%20name%3A%20sacituzumab%20govitecan,two%20or%20more%20systemic%20therapies.' target='_blank'>Breastcancer.org: Sacituzumab govitecan-hziy (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation: Home</a> </li></ul>

107

NEAREST SITE: 210 miles
PCR Oncology
Arroyo Grande,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05554354

Fulvestrant Alone or With Binimetinib Targeted Therapy for Metastatic HR+, HER2- Breast Cancer with a NF1 Mutation

A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1 Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy alone or with binimetinib (Mektovi®) MEK inhibitor.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a NF1 mutation who have received treatment with a CDK 4/6 inhibitor. You must not have received more than 1 line of chemotherapy for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®), by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT, MRI, or bone scan, 2 times</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors, which may inhibit the growth of estrogen-sensitive tumor cells.</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is a type of targeted therapy called a MEK inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">Targets or mutations: NF1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05554354' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618041.html' target='_blank'>Medline Plus: Binimetinib (Mektovi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

108

NEAREST SITE: 250 miles
Research Site
Bakersfield,CA

VISITS: 1 visit every 1-3 weeks for 1 year

PHASE: III

NCT ID: NCT06112379

Dato-DXd ADC and Immunotherapy Before Surgery for Stage II-III Triple Negative or HR Low, HER2- Breast Cancer

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Tr... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) datopotamab deruxtecan (Dato-DXd), an experimental antibody drug conjugate, and durvalumab (Imfinzi®) PD-1 inhibitor with or without chemotherapy compared to standard of care.

Who is this for?

People with newly diagnosed stage II or stage III triple negative (ER-, PR-, HER2-) or hormone receptor low (ER low and/or PR low), HER2 negative (HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks, for 6 months before surgery</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, for 6 months before surgery</li> </ul> followed by (after surgery): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, before surgery</li> <li class="seamTextUnorderedListItem">Chemotherapy, before surgery</li> </ul> followed by (after surgery): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) combines an antibody that targets cancer cells with a therapy that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Because it only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Dato-DXd's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are types of immunotherapy called PD-L1 inhibitors, which are a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a targeted therapy called a PARP inhibitor, which work by blocking the action of an enzyme that helps repair DNA. It will be given to people with residual disease and BRCA positive (BRCA+) tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06112379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html#oncology' target='_blank'>AstraZeneca: Datopotamab Deruxtecan (Dato-DXd) Drug Information Page</a> </li></ul>

109

NEAREST SITE: 273 miles
Research Site
Santa Barbara,CA

VISITS: 1 visit every 1-3 weeks

PHASE: III

NCT ID: NCT06018337

DB-1303/BNT323 Antibody Drug Conjugate for Advanced HR+, HER2 Low Breast Cancer

A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of DB-1303/BNT323, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 low breast cancer who have received 1-2 lines of therapy for advanced disease. You must not have received chemotherapy for advanced disease or any anti-HER2 targeted therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1303/BNT323, by IV, every 3 weeks</li> </ul> Group 2: Standard of Care Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">One of the following:</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1303/BNT323 is an experimental antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">DB-1303/BNT323's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), paclitaxel (Taxol®), or nab-paclitaxel (Abraxane®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06018337' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dualitybiologics.com/pipeline.html' target='_blank'>DualityBio: DB-1303 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dualitybiologics.com/approach.html?md=1' target='_blank'>DualityBio: ADC Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

110

NEAREST SITE: 318 miles
City of Hope Antelope Valley
Lancaster,CA

VISITS: 1 to 10 visits over 1 month

PHASE: III

NCT ID: NCT03550391

Stereotactic Radiation or Memory Sparing Whole-Brain Radiation for Patients with 5-15 Brain Metastases

A Phase III Trial of Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases Scientific Title

Purpose

To compare the anti-cancer activity and side effects of stereotaxic radiation with memory-sparing, whole-brain radiation, To preserve memory, radiation will avoid the hippocampus, an area of the brain associated with memory, and be given with Memantine, a drug used to treat memory loss caused by dementia.

Who is this for?

People with metastatic (stage IV) breast cancer and 5-15 brain metastases. You must not have received prior radiation or surgery for brain metastases (mets). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole-brain radiation</li> <li class="seamTextUnorderedListItem">Memantine, by mouth, twice a day, for 4 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation to metastatic brain metastases</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery.</li> <li class="seamTextUnorderedListItem">Whole-brain radiation therapy (WBR) typically targets the entire brain, including the hippocampus. By avoiding the hippocampus, researchers hope to lessen the side effects of WBR.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery) delivers focused radiation to each metastasis (met/tumor).</li> <li class="seamTextUnorderedListItem">Memantine is a medication approved for use in people with dementia, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer that have spread to the brain.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03550391' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-77932-377/memantine-oral/memantine-oral/details' target='_blank'>Memantine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellmind.com/what-is-the-hippocampus-2795231' target='_blank'>What is the Hippocampus?</a> </li></ul>

111

NEAREST SITE: 336 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02264678

Ceralasertib Alone or With Chemotherapy or With Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies. Scientific Title

Purpose

To study the safety, effects, and best dose of Ceralasertib when it is used alone or with the chemotherapy carboplatin or the PARP inhibitor olaparib (Lynparza®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1: Open to all MBC patients <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 4.5 months</li> </ul> Group 2: Open to all MBC patients <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth</li> </ul> Group 3: Open to Triple Negative Breast Cancer MBC patients with or without a BRCA mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib is a new type of targeted therapy called an ATR inhibitor. </li> <li class="seamTextUnorderedListItem">It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. </li> <li class="seamTextUnorderedListItem">Carboplatin is a chemotherapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor approved to treat BRCA 1 or BRCA 2 positive metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02264678' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: Ceralasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/olaparib' target='_blank'>NCI Drug Dictionary: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/targeting-cancers-achilles-heel-dna-damage-response-networks-beyond-parp' target='_blank'>OncLive: DNA Damage Response Networks Beyond PARP</a> </li></ul>

112

NEAREST SITE: 336 miles
University of California, Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03401385

DS-1062a in Advanced Triple Negative Breast Cancer

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of DS-1062a.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a is an investigational antibody-drug conjugate (ADC). This type of drug uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets Trop2 proteins. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03401385' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793720' target='_blank'>NCI Drug Dictionary: DS-1062a</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

113

NEAREST SITE: 336 miles
Ethan Lam
Los Angeles,CA

VISITS: 2-3 visits

PHASE: NA

NCT ID: NCT04147494

PET/CT Scans Before Surgery for People with Stage I-IV Breast Cancer

PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-prostate Cancers: an Exploratory Study With Histopathology Validation Scientific Title

Purpose

To study where 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulate in normal and cancer tissues and whether PET/CT scans with 68Ga-FAPi-46 and 68Ga-PSMA-11 can help locate cancer in the body.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are planning to receive surgery to remove the primary tumor and/or metastasis. Full eligibility criteria

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How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">68Ga-FAPi-46, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/CT scan, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">18F-FDG, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/CT scan, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">68Ga-PSMA-11, by IV, 1 time (optional)</li> <li class="seamTextUnorderedListItem">PET/CT scan, 1 time (optional)</li> </ul> Please contact research site for trial schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">68Ga-FAPi-46 and 68Ga-PSMA-11 are experimental tracers for imaging scans that may help locate cancer in the body.</li> <li class="seamTextUnorderedListItem">18F-FDG is a tracer routinely used for imaging scans that helps locate cancer in the body.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic (body processes) information obtained from the PET scan. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04147494' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/pet-ct-fdg' target='_blank'>Memorial Sloan Kettering Cancer Center: PET/CT Scans with 18F-FDG Tracer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/gallium-ga-68-fapi-46' target='_blank'>National Cancer Institute: 68Ga-FAPi-46</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/gallium-ga-68-psma-11-intravenous-route/description/drg-20506366' target='_blank'>Mayo Clinic: 68Ga-PSMA-11</a> </li></ul>

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NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: 2 visits within 2 months

PHASE: II

NCT ID: NCT04290897

Oxaloacetate to Reduce Side Effects After Treatment in People with DCIS and Stage I-III Breast Cancer

A Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors Scientific Title

Purpose

To study the safety and ability of oxaloacetate to reduce brain problems, fatigue, sleep problems, and depression after breast cancer treatment.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or some stage III breast cancer who have completed treatment. You must have been diagnosed no more than 5 years ago. Full eligibility criteria

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