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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.

Use the search box and filters to find a trial that’s right for you.

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(Last updated: March 18, 2023)

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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: n/a

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

VISITS: Weekly visits for 4 months

PHASE: II

NCT ID: NCT01042379

Personalized Treatment Before Surgery For Stage II-III Breast Cancer: The I-SPY 2 Trial

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

Purpose

To compare the safety and anti-cancer activity of giving the standard of care to giving the standard of care plus an experimental drug that was chosen based on your tumor's biomarkers.

Who is this for?

People with stage II or stage III breast cancer who have not yet started treatment and whose cancer is considered 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 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least one experimental therapy that is 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">This clinical trial has an <q>adaptive design.</q> 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 prior to 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 High or MammaPrint Low (but only if your tumor is ER- or HER2+).</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test (analyzes your tumor) that gives two types of recurrence 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://en.wikipedia.org/wiki/MammaPrint' target='_blank'>Wikipedia: 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-SPY2 Adaptively Randomized Clinical Trial</a> </li></ul>

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

VISITS: Weekly visits for 5 months

PHASE: III

NCT ID: NCT02488967

AC Chemo Followed by Taxol with or without Paraplatin for Stage I-III Triple Negative Breast Cancer

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast CancerDoxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer Scientific Title

Purpose

To compare the effects (good and bad) of AC followed by Taxol followed by Paraplatin to AC followed by Taxol.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer. You must have had breast cancer surgery with clear margins (cancer free area around where tumor was removed). Full eligibility criteria

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Participants will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AC (Adriamycin® and Cytoxan®),by IV, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">followed by paclitaxel (Taxol®), by IV, weekly, for 3 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AC (Adriamycin® and Cytoxan®), by IV, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">followed by paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">followed by carboplatin (Paraplatin®), by IV, every 3 weeks, for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC--and paclitaxel (Taxol®) are chemotherapies routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a platinum-based chemotherapy that studies suggest is effective for triple-negative breast cancer.</li> <li class="seamTextUnorderedListItem">Patients who did not have clean margins will need to have radiation therapy to the chest wall before entering the trial.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02488967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www2.mdanderson.org/cancerwise/2015/04/finding-hope-after-triple-negative-breast-cancer.html' target='_blank'>MD Anderson Cancer Center: Hope After Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center Research Institute
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 evaluate the safety and effects (good and bad) of using a tumor's genetic alterations to select an FDA-approved targeted therapy for treatment.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer for whom there is no currently available therapy. You must have results from a genomic or immunohistochemistry test approved by TAPUR. Full eligibility criteria

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Participants will receive an FDA-approved targeted therapy that is chosen based on the tumor's genetic makeup.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's specific genetic profile.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Afatinib, Crizotinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, 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 Study Website: TAPUR</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: About TAPUR (video)</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
University of California San Francisco
San Francisco,CA

VISITS: 2-3 visits a month, ongoing

PHASE: II

NCT ID: NCT03414658

Herceptin and Navelbine with One or Two Immunotherapies for Advanced HER2+ Breast Cancer

A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzumab (AVIATOR) Scientific Title

Purpose

To study and compare the safety and anti-cancer activity of using trastuzumab (Herceptin®) and chemotherapy to using trastuzumab (Herceptin®), chemotherapy, and one or two experimental immunotherapies.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. 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">Trastuzumab (Herceptin®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, 3 times over 1 month</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, 3 times over 1 month</li> <li class="seamTextUnorderedListItem">Avelumab (Bevancio®), by IV, every 2 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, 3 times over 1 month</li> <li class="seamTextUnorderedListItem">Avelumab (Bevancio®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Utomilumab (PF-05082566), by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a targeted therapy routinely used to for HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®) is a chemotherapy drug used to for HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Avelumab (Bevancio®) and utomilumab (PF-05082566) are immunotherapies that work by stimulating the body's immune system to go after cancer cells. Both work by blocking a protein called PD-L1. </li> <li class="seamTextUnorderedListItem">Bevancio is approved to treat metastatic Merkel cell carcinoma and urothelial (bladder) cancers. Its use is considered experimental in breast cancer. </li> <li class="seamTextUnorderedListItem">Utomilumab is an experimental treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03414658' target='_blank'>ClinicalTrials.gov</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.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/vinorelbine-navelbine' target='_blank'>Breast Cancer Care UK: Navelbine</a> </li><li class='seamTextUnorderedListItem'><a href='https://externalmediasite.partners.org/Mediasite/Play/203c8412eda144b7afc0aae750805b2c1d' target='_blank'>Dana-Farber Cancer Institute: Patient-friendly informational video about this trial</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: NCT03504488

AB-ROR2-ADC for Advanced Breast Cancer

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of an experimental drug called CAB-ROR2-ADC (BA3021).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAB-ROR2-ADC (BA3021) </li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAB-ROR2-ADC is a type of drug called an antibody-drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets ROR2 proteins. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03504488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/794991' target='_blank'>NCI Drug Dictionary: CAB-ROR2-ADC</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/13_Supplement/833' target='_blank'>Cancer Research: Anti-tumor efficacy of BA3021</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.hematologyandoncology.net/archives/april-2017/antibody-drug-conjugates-in-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: ADC in Breast Cancer</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03554044

Imlygic With Taxol or Hormone Therapy for Advanced HER2 Negative Breast Cancer

A Phase 1b Study of Talimogene Laherparepvec (T-VEC) in Combination With Paclitaxel or Endocrine Therapy in Patients With Metastatic, Unresectable, or Locoregionally Recurrent HER2-Negative Breast Cancer With Evidence of Injectable Disease in the Locoregional Area Scientific Title

Purpose

To study the safety, anti-tumor activity and effects (good and bad) of combining talimogene laherparepvec (Imlygic®) with paclitaxel (Taxol®) or a hormone therapy of their doctor's choice.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. 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: Estrogen receptor negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talimogene laherparepvec (Imlygic®), by injection, every 2 weeks for 3 months, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week</li> </ul> Group 2: Estrogen receptor positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talimogene laherparepvec (Imlygic®), by injection, every 2 weeks for 3 months, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Hormone therapy (doctor's choice)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talimogene laherparepvec (Imlygic®) is an immunotherapy approved to treat advanced melanoma. It is injected directly into a tumor site. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">Paclitaxel will be used with Imylgic® to treat estrogen receptor negative (ER-) patients. </li> <li class="seamTextUnorderedListItem">Study participants with estrogen receptor positive (ER+) tumors will be treated with Imylgic® and a hormone therapy selected by their doctor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03554044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/talimogene-laherparepvec' target='_blank'>NCI Dictionary of Cancer Terms: Talimogene Laherparepvec</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/breast-cancer/adding-oncolytic-virus-neoadjuvant-chemo-triple-negative-breast-cancer' target='_blank'>Cancer Network: Adding an Oncolytic Virus to Neoadjuvant Chemo for Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/paclitaxel-taxol' target='_blank'>Breast Cancer Now: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/hormonal' target='_blank'>Breastcancer.org: Hormonal Therapy to Treat Metastatic Breast Cancer</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 giving a combination of two experimental immunotherapies after the standard of care has been completed.

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 chemotherapy. 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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What's being studied?
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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
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03739931

mRNA-2752 & Durvalumab for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36ÃŽ³, for Intratumoral Injection Alone and in Combination With Immune Checkpoint Blockade Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of mRNA-2752 when it is combined with durvalumab (Imfinzi®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has already been treated with adequate standard of care therapies. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">mRNA-2752, by injection</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">mRNA-2752 is injected directly into a tumor. It is designed to make a tumor more responsive to an immunotherapy drug. </li> <li class="seamTextUnorderedListItem">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. 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/NCT03739931' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ph&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>AstraZeneca Drug Information Page: Imfinzi®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796816' target='_blank'>NCI Drug Dictionary: mRNA-2752</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/79/13_Supplement/CT210' target='_blank'>AACR Abstract: mRNA-2752</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.modernatx.com/pipeline/therapeutic-areas/immuno-oncology' target='_blank'>Drug Company Information Page: Intratumoral Immuno-Oncology Therapeutics</a> </li><li class='seamTextUnorderedListItem'><a href='https://stm.sciencemag.org/content/11/477/eaat9143.full?ijkey=nRihB/hFvaoUw&keytype=ref&siteid=scitransmed' target='_blank'>Journal Article: Durable anticancer immunity from intratumoral administration of IL-23, IL-36γ, and OX40L mRNAs</a> </li></ul>

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

VISITS: 1 visit per month, ongoing

PHASE: II

NCT ID: NCT03941730

Estradiol in Advanced Triple Negative & ER-Low Tumors that Test Positive for ER Beta

Therapeutic Targeting of ER Beta in Triple Negative Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) of estradiol in the subset of triple negative and ER-Low tumors that test positive for ER beta.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer whose tumor tests positive for estrogen receptor beta (ER beta). Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 3 times a day</li> <li class="seamTextUnorderedListItem">2 biopsies (at the start of treatment and after 1 month)</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">Early studies suggest that estradiol--a type of estrogen--slows the growth of tumors that are ER-beta positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ER beta</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03941730' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Estrogen_receptor_beta' target='_blank'>Wikipedia: Estrogen receptor beta</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/estradiol.html' target='_blank'>Drugs.com: Estradiol</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/centers-programs/cancer-research/research-programs/womens-cancer-program/breast-cancer-spore/research-projects/therapeutic-targeting-estrogen-receptor-beta-triple-negative-breast-cancer' target='_blank'>Mayo Clinic: Therapeutic Targeting Estrogen receptor-beta in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/30338035' target='_blank'>Journal Abstract: Estrogen receptor-beta is a potential target for TNBC</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 & 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: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arraybiopharma.com/our-science/our-pipeline/binimetinib' target='_blank'>Array Biopharma: BINIMETINIB</a> </li></ul>

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

VISITS: At least 1 visit every 2 months

PHASE: I-II

NCT ID: NCT03997968

CYT-0851 for Advanced Solid Tumors and Some Types of Blood Cancers

A Multi-Center, Open Label Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors Scientific Title

Purpose

To study the safety and best dose of CYT-0851, a type of targeted therapy called a RAD51 inhibitor.

Who is this for?

People with triple negative (ER-, PR-, HER2-) metastatic (stage IV) breast cancer that tests positive for a protein called activation-induced cytidine deaminase (AID). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CYT-0851, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RAD51 is a protein that helps cells repair DNA damage. Blocking this process may keep tumors from growing. </li> <li class="seamTextUnorderedListItem">Tumors that test positive for a protein called activation-induced cytidine deaminase (AID) may have high rates of DNA damage. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03997968' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/breast-cancer/rad51-linked-parp-inhibitor-resistance-brca-mutated-breast-cancer' target='_blank'>CancerNetwork.com: RAD51</a> </li></ul>

NEAREST SITE: 3 miles
USCF
San Francisco,CA

VISITS: 4 visits the first month, then 1 visit a month, ongoing

PHASE: II

NCT ID: NCT04024436

TAS-120 (Futibatinib) for Advanced HER2 Negative Breast Cancer with FGFR Amplification

A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications Scientific Title

Purpose

To study the safety and anti-cancer activity of the FGFR inhibitor TAS-120 (futibatinib).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer that tests positive for certain FGFR gene amplifications. You must have already received at least one treatment for advanced disease. Full eligibility criteria

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You will be assigned to 1 of 2 groups depending on the hormone status of your cancer: Group 1: Hormone negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAS-120 (futibatinib), by mouth, daily, ongoing</li> </ul> Group 2: Hormone positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAS-120 (futibatinib), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly, ongoing</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly, ongoing ( only if you are premenopausal)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAS-120 (futibatinib) is a type of targeted therapy called a kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It is designed to block the FGFR (fibroblast growth factor receptor) protein.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Targets or mutations: FGFR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04024436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fgfr-inhibitor-tas-120' target='_blank'>NCI Drug Dictionary: Futibatinib</a> </li><li class='seamTextUnorderedListItem'><a href='http://targetedcancercare.massgeneral.org/My-Trial-Guide/Diseases/Breast-Cancer/FGFR-1,-2,-3-and-4.aspx' target='_blank'>Massachusetts General Hospital Cancer Canter: Breast Cancer, FGFR</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.faslodex.com/home.html' target='_blank'>AstraZeneca Drug Information Page: (Faslodex®) Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/hormone-therapy/goserelin-zoladex' target='_blank'>Breast Cancer Now: Goserelin</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04042701

Trastuzumab Deruxtecan and Pembrolizumab for Advanced HER2 Positive and HER2 Low Expression 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 find the best dose and to study the safety, effects (good and bad), and anti-tumor activity of the targeted therapy fam-trastuzumab deruxtecan-nxki (Enhertu®) when it is given in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer whose cancer progressed after receiving 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">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug 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://en.wikipedia.org/wiki/Pembrolizumab' target='_blank'>Wikipedia: Pembrolizumab</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04190056

Immunotherapy, Hormone Therapy, and Chemotherapy for ER Positive Stage IV Breast Cancer

Epigenetic Priming for Immune Therapy in ER-Positive Breast Cancer in Biomarker Select Population Scientific Title

Purpose

To study and compare the safety, side effects, and anti-cancer activity of giving hormone therapy and immunotherapy with or without chemotherapy.

Who is this for?

People with metastatic (stage IV) estrogen receptor-positive (ER+) breast cancer that tests positive for PD-1/CTLA-4 expression. 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, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®), by mouth, daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved for use in many cancers, including in people with advanced triple-negative breast cancer in combination with chemotherapy, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®) is chemotherapy approved to treat another type of cancer. Its use in this trial is considered investigational. </li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is commonly used to treat hormone-positive breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04190056' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/next-generation-of-combo-regimens-being-explored-in-er-breast-cancer' target='_blank'>OncLive: Next Generation of Combo Regimens Being Explored in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a607050.html' target='_blank'>MedLinePlus: Vorinostat (Zolinza®)</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04254107

Experimental SEA-TGT For Advanced Triple Negative Breast Cancer

A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies Scientific Title

Purpose

To study the dose, safety, side effects and anti-cancer activity of giving the experimental immunotherapy SEA-TGT.

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">SGN-TGT, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-TGT is an experimental 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/NCT04254107' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20491268' target='_blank'>Mayo Clinic Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/clinical-trials' target='_blank'>Seagen Drug Information Page: SGN-TGT</a> </li></ul>

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

VISITS: 1 visit every 3-6 weeks

PHASE: I

NCT ID: NCT04257110

BB-1701 ADC for Advanced HER2 Positive or HER2 Low Breast Cancer

A First-in-human, Open Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors Scientific Title

Purpose

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

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low (IHC 1+ or 2+) breast cancer. If your cancer is hormone receptor positive (ER+ and/or PR+), you must have received at least 1 line of hormone therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BB-1701, by IV, every 3-6 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</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+/FISH +.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</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/NCT04257110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ceccapitalgroup.com/index.php?a=shows&catid=3&id=566' target='_blank'>Bliss Biopharmaceutical Press Release: BB-1701</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://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing: A New Subcategory of HER2-Negative Breast Cancer?</a> </li></ul>

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

VISITS: 2 visits over 4 months

PHASE: II

NCT ID: NCT04316117

Using PET/CT Scans to See How Breast Cancer That Has Spread to the Bones is Responding to Therapy

FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE Scientific Title

Purpose

To study if PET/CT scans with a FDG tracer find tumors missed by standard of care imaging and can see how breast cancer tumors that have spread to the bones are responding to therapy.

Who is this for?

People with stage IV (metastatic) breast cancer that has spread to their bones and who have not received more than 3 chemotherapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FDG tracer, by IV, followed by PET/CT scan, 2 times (1 scan before treatment, 1 scan 3 months after starting treatment)</li></ul>
<ul class="seamTextUnorderedList"> <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">This imaging trial will use a tracer called FDG (fluorodeoxyglucose). </li> <li class="seamTextUnorderedListItem">FDG produces color-coded images that show normal and cancerous tissue.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04316117' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/clinical-trials/ea1183-educational-materials' target='_blank'>ECOG-ACRIN Study Information Page: FEATURE</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/tests/pet-ct-scan' target='_blank'>Cancer Research UK: PET-CT Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.docpanel.com/blog/post/understanding-your-fdg-pet-scan' target='_blank'>Docpanel: Understanding Your FDG PET Scan</a> </li></ul>

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

VISITS: At least 1 visit every 2 weeks

PHASE: II

NCT ID: NCT04434040

Immunotherapy and Targeted Therapy After Chemo and Surgery to Prevent Recurrence in Stage I-III Triple Negative Breast Cancer

Combination Ipatasertib and Atezolizumab to Prevent Recurrence in Triple Negative Breast Cancer Scientific Title

Purpose

To study if receiving the immunotherapy atezolizumab (Tecentriq®) in combination with the targeted therapy ipatasertib after receiving neoadjuvant chemotherapy and surgery helps prevent recurrence.

Who is this for?

People who received chemotherapy before surgery for triple negative (ER-, PR-, HER2-) breast cancer and were found to still have tumor cells in a breast or lymph node and have evidence of circulating tumor DNA (cfDNA) in their blood. You must be within 1 year of finishing treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved for use in women with advanced and metastatic triple negative breast cancer. Its use in early-stage breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Ipatasertib is a type of targeted therapy called an AKT inhibitor. AKT is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA tests look for evidence of breast cancer cells that have left the tumor and are moving through the bloodstream.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04434040' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pathologic-complete-response' target='_blank'>NCI Dictionary of Cancer Terms: Pathological Complete Response</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/ipatasertib-survival-results-continue-to-impress-in-tnbc' target='_blank'>OncLive: Ipatasertib Survival Results Continue to Impress in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI Cancer Currents Blog: Atezolizumab Approved for Some Patients with Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20191218/circulating-tumor-dna-predicts-recurrence-in-earlystage-triplenegative-breast-cancer' target='_blank'>HemOnc Today: Circulating Tumor DNA Predicts Recurrence in Early-Stage TNBC</a> </li></ul>

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

VISITS: 1 visit per week

PHASE: I-II

NCT ID: NCT04478279

ST101 Targeted Therapy for Advanced HR+ Breast Cancer

A Phase 1-2 Dose-escalation and Expansion Study of ST101 in Patients With Advanced Unresectable and Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ST101, an experimental targeted therapy called a C/EBPβ inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer that has progressed after 1 or 2 hormone therapies. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ST101, by IV, weekly</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ST101 is an experimental targeted therapy called a C/EBPβ inhibitor. Blocking C/EBPβ may slow or stop cancer cells from growing.</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/NCT04478279' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sapiencetherapeutics.com/pipeline/st101' target='_blank'>Sapience Therapeutics Drug Information Page: ST101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</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
University of California at San Francisco
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04539938

Tucatinib and Trastuzumab Deruxtecan for Advanced HER2 Positive Breast Cancer

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity and side-effects of giving tucatinib (Tukysa) in combination with fam-trastuzumab deruxtecan-nxki (Enhertu®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must have already received at least two anti-HER2 targeted therapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. </li> <li class="seamTextUnorderedListItem">Tucatinib is approved for use in people with metastatic, HER2+ breast cancer when it is taken with for use trastuzumab and capecitabine. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 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/NCT04539938' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/tukysa' target='_blank'>Breastcancer.org: Tukysa</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/view/what-you-need-to-know-about-the-fdas-approval-of-tukysa-for-her2positive-breast-cancer' target='_blank'>Cure Today: What You Need to Know About the FDA's Approval of Tukysa for HER2 Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqjw8fr7brdsarisak0qqr5x8-k8j8h3d3_wahp-jhjvjjtjaqr3dnefidhs2onmte7b9gbmcfmaaoteealw_wcb&gc' target='_blank'>Daiichi-Sankyo AstraZeneca Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/brufsky-spotlights-data-with-trastuzumab-deruxtecan-in-her2-metastatic-breast-cancer' target='_blank'>OncLive: Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer</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
Research Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04644068

Experimental PARP Inhibitor AZD5305 Alone or with Chemotherapy for Advanced Breast Cancer

A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving the experimental PARP inhibitor AZD5305 alone or with one or two chemotherapies.

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 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD5305</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD5305</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD5305</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD5305</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">AZD5305 is an experimental PARP inhibitor.</li> <li class="seamTextUnorderedListItem">Both paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapies commonly used for breast cancer. </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/NCT04644068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/parp-inhibitors-cancer/' target='_blank'>Metastatic Trial Talk: PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Paclitaxel.aspx' target='_blank'>Chemocare.com: Paclitaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/carboplatin' target='_blank'>Cancer Research UK: Carboplatin</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04665921

SGN-STNV for Advanced, HER2 Negative Breast Cancer

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

Purpose

To study the safety, side effects and anti-cancer activity of the experimental therapy SGN-STNV.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) 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-STNV, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04665921' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com' target='_blank'>Seagen Company Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tandfonline.com/doi/full/10.1080/19420862.2017.1290752' target='_blank'>mAbs: novel Novel anti-Sialyl-Tn ADC with anti-tumor activity</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Mount Zion Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04682431

PY159 Targeted Therapy for Advanced Breast Cancer

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PY159, an experimental targeted therapy called a TREM1 agonist, alone and with pembrolizumab (Keytruda®), a type of immunotherapy called an immune checkpoint 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 that has progressed on at least 1 line of therapy. If your cancer is triple negative and PD-L1 positive (PD-L1+), you must have received treatment with at least one PD-1/PD-L1 inhibitor. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PY159</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PY159</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">At least 1 biopsy required</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PY159 is an experimental targeted therapy called a TREM1 agonist, which activates TREM1 and activates the immune system to attack 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/NCT04682431' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pionyrtx.com/pipeline/py159/' target='_blank'>Pionyr Immunotherapeutics Drug Information Page: PY159</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
Kaiser Permanente-San Francisco
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
University of California San Francisco Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04869943

Enobosarm for Androgen Receptor Positive (AR+), ER+, HER2- Metastatic Breast Cancer

Randomized Phase 3 Efficacy Evaluation of Enobosarm Monotherapy vs Control Treatment of AR+/ER+/HER2- MBC in Patients With AR Nuclei Staining ≥40% Who Has Shown Disease Progression on a Nonsteroidal AI Fulvestrant and CDK 4/6 Inhibitor. (ARTEST) Scientific Title

Purpose

To study the anti-cancer activity of Enobosarm, an experimental selective androgen receptor modulator (SARM).

Who is this for?

People with metastatic (stage IV) androgen receptor positive (AR+), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. Your tumor must have already been treated with fulvestrant (Faslodex®), an aromatase inhibitor, and a CDK 4/6 inhibitor. 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">Enobosarm, by mouth, daily</li> </ul> Group 2: Standard care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estrogen receptor targeted therapy (standard of care at the clinical study site)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enobosarm is a selective androgen receptor modulator (SARM) that targets the androgen receptor (AR).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04869943' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-enobosarm-in-ar-er-her2--metastatic-breast-cancer' target='_blank'>Cancer Network: FDA Grants Fast Track Designation to Enobosarm in AR+, ER+, HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/enobosarm-generates-overdue-excitement-in-ar-er-metastatic-breast-cancer' target='_blank'>OncLive: Enobosarm Generates Overdue Excitement in AR+/ER+ Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/enobosarm' target='_blank'>Cancer.gov definition: Enobosarm</a> </li><li class='seamTextUnorderedListItem'><a href='https://verupharma.com/pipeline/enobosarm-abemaciclib-combination-therapy-for-breast-cancer/' target='_blank'>Sponsor (Veru Pharma) Drug Information page: Enobosarm</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
UCSF Medical Center at Mission Bay ( Site 0043)
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT04895358

Pembrolizumab and Chemotherapy for Advanced Hormone-Positive, HER2-Negative, PD-L1 Positive Breast Cancer

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49) Scientific Title

Purpose

To study the safety and anti-cancer activity of giving the immunotherapy pembrolizumab (Keytruda®) with chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2-negative (HER2-), PD-L1 positive breast cancer. Your tumor will be tested for PD-L1. You must have already received at least one anti-hormone therapy for advanced disease. Also, you must not have already received chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">You will be given one of four commonly used chemotherapies: paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), liposomal doxorubicin (Doxil®), or capecitabine (Xeloda®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04895358' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Pembrolizumab.aspx' target='_blank'>Chemocare: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>MedLinePlus: PD-L1 (Immunotherapy) Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://merckoncologyclinicaltrials.com/en-us/patient/trial/NCT04895358' target='_blank'>Merck Oncology Study Information</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04915755

Niraparib for HER2- Breast Cancer with a Tumor BRCA Mutation and Triple Negative Breast Cancer

A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of niraparib.

Who is this for?

People with stage I, stage II, or stage III HER2 negative (HER2-) breast cancer with a tumor BRCA mutation or triple negative (ER-, PR-, HER2-) breast cancer with any BRCA status. You must have completed standard treatment and test positive for detectable disease with a ctDNA test. 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">Niraparib (Zejula®)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for niraparib (Zejula®)</li> </ul> Please contact research site for treatment schedule
<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">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">Targets or mutation: BRCA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04915755' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/st-gallen-international-breast-cancer-conference/sg-bcc-2021/breast-cancer-her2-niraparib-anti-tumor-brca-treatment-risk/' target='_blank'>Cancer Therapy Advisor: Niraparib in HER2- Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617007.html' target='_blank'>MedlinePlus: Niraparib</a> </li></ul>

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

VISITS: At least 3 visits per month

PHASE: II

NCT ID: NCT04958785

Magrolimab with Chemotherapy for Advanced Triple-Negative Breast Cancer

A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Nab-Paclitaxel or Paclitaxel Versus Nab-Paclitaxel or Paclitaxel in Previously Untreated Patients With Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of magrolimab (GS-4721), an experimental targeted therapy, with nab-paclitaxel (Abraxane®) or paclitaxel (Taxol®) chemotherapies.

Who is this for?

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

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magrolimab (GS-4721), by IV</li> <li class="seamTextUnorderedListItem">Nab-Paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magrolimab (GS-4721), by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-Paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require a biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Magrolimab (GS-4721) is an experimental targeted therapy called a CD47 inhibitor.</li> <li class="seamTextUnorderedListItem">The CD47 pathway helps cancer cells escape attack from the immune system which helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Magrolimab (GS-4721) may block the CD47 pathway. </li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) and paclitaxel (Taxol®) are chemotherapy drugs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04958785' target='_blank'>ClinicalTrials.gov</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.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-Paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/gileads-magrolimab-an-investigational-anticd47-monoclonal-antibody-receives-fda-breakthrough-therapy-designation-for-treatment-of-myelodysplastic' target='_blank'>Gilead sciences (sponsor) press release: Magrolimab</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
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
UCSF Medical Center at Mission Bay
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: 4 miles
Kaiser Permanente - San Francisco Medical Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04546009

Hormone Therapy GDC-9545 or Letrozole with Palbociclib for Stage III ER+, HER2- Breast Cancer

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose

To compare the safety and anti-cancer activity of giving palbociclib (Ibrance®) with the hormone therapy letrozole (Femara®) to giving palbociclib with the experimental hormone therapy GDC-9545.

Who is this for?

People with locally advanced (stage III) estrogen receptor-positive (ER+), HER2 negative (HER2-) breast cancer who have not yet started treatment for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-9545, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 2: Standard <ul class="seamTextUnorderedList"> <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">Palbociclib (Ibrance®), a CDK 4/6 inhibitor, is commonly used in combination with either letrozole (Femara®) or fulvestrant (Faslodex®) for metastatic, hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer.</li> <li class="seamTextUnorderedListItem">GDC-9545 is an experimental anti-estrogen therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04546009' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/hormonal-therapy-metastatic-breast-cancer' target='_blank'>ASCO Cancer.Net: Hormonal Therapy for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/giredestrant' target='_blank'>NCI Drug Dictionary: GDC-9545</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</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
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: 5 visits per week, for 6 weeks

PHASE: II

NCT ID: NCT03598257

Radiation Therapy With or Without Olaparib For Inflammatory Breast Cancer

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer (SWOG 1706) Scientific Title

Purpose

To compare the benefits and the effects (good and bad) of using radiation therapy along with a PARP inhibitor to radiation therapy alone.

Who is this for?

People with stage III inflammatory breast cancer. 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">Olaparib (Lynparza®), by mouth, twice daily, for 6 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy, 5 days a week, for 6 weeks</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy, 5 days a week, for 6 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03598257' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/fda-olaparib-breast-brca-mutations' target='_blank'>NCI: Olaparib Approved for Treating Some Breast Cancers with BRCA Gene Mutations</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/olaparib' target='_blank'>NCI: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/inflammatory' target='_blank'>Breastcancer.org: Inflammatory Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.swog.org/clinical-trials/s1706' target='_blank'>SWOG Cancer Research Network: Trial information</a> </li></ul>

NEAREST SITE: 8 miles
Bay Area Breast Surgeons Inc
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
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03994796

Genetic Testing for Choosing a Targeted Therapy for Brain Metastases that Test Positive for Certain Mutations

Genomically-Guided Treatment Trial in Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity of choosing a targeted therapy for brain metastases based on the genetic mutations found in your tumors.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread (metastasized) to your brain with a gene mutation or alteration in: NTRK, ROS1, CDK or PI3K. You must have already received at least one treatment for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 3 groups depending on which genetic mutations are found in your tumors: Group 1: CDK-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> </ul> Group 2: PI3K-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily, ongoing</li> </ul> Group 3: NTRK or ROS1-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples from your brain and other parts of your body will be tested for mutations. This is called genomic testing.</li> <li class="seamTextUnorderedListItem">You will be assigned a targeted therapy based on which genetic mutations are found in your tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK, ROS1, CDK, PI3K</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03994796' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/hcp/patient-profiles' target='_blank'>Eli Lilly & Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rozlytrek.com' target='_blank'>Genentech USA Drug Information Page: Rozlytrek (Entrectinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-inhibitor-gdc-0084' target='_blank'>NCI Drug Dictionary: GDC-0084</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>Journal Article: Targeting the Sanctuary Site, Options when Breast Cancer Metastasizes to the Brain</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 Therapy in Patients With HER2-Negative Breast Cancer and 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: 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 (Eligard®), 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 (Eligard®) 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.tolmar.com/products/eligard' target='_blank'>Tolmar Drug Information Page: Eligard® (Leuprolide Acetate)</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
Greenbrae,CA

VISITS: 1 visit every month

PHASE: III

NCT ID: NCT04975308

Imlunestrant for Advanced ER+, HER2- Breast Cancer

EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy Scientific Title

Purpose

To compare the effects (good and bad) and anti-cancer activity of imlunestrant, a selective estrogen receptor degrader (SERD), given alone or with abemaciclib (Verzenio®), to endocrine 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 experienced disease progression while taking an aromatase inhibitor. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Endocrine therapy (exemestane/Aromasin®, by mouth or fulvestrant/Faslodex®, by injection)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356) is an experimental anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) and fulvestrant (Faslodex®) are hormone therapies 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">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, 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/NCT04975308' 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.newswire.ca/news-releases/lilly-announces-new-clinical-data-from-verzenio-and-oral-serd-programs-at-the-american-society-of-clinical-oncology-annual-meeting-859069920.html' target='_blank'>Eli Lilly Press Release: Imlunestrant (LY3484356)</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/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</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: 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: 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 Hospital and Clinics
Stanford,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04901806

PBI-200 Targeted Therapy for Advanced Breast Cancer with a NTRK Mutation

A Phase 1/2 Study of PBI-200 in Subjects With NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PBI-200, an experimental targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a NTRK mutation who have received at least 1 line of therapy for advanced disease. You must have received treatment with larotrectinib (Vitrakvi®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBI-200, by mouth</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBI-200 is an experimental targeted therapy called a TRK inhibitor. Blocking TRK may help slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04901806' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://pyramidbio.com/pipeline/' target='_blank'>Pyramid Biosciences Drug Information Page: PBI-200</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pan-trk-inhibitor-pbi-200?redirect=true' target='_blank'>National Cancer Institute: PBI-200</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05012397

Milademetan Targeted Therapy for Advanced Breast Cancer With TP53 and MDM2 Gene Amplification

A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of milademetan (RAIN-32), an experimental MDM2 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with TP53 and MDM2 gene amplification 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">Milademetan (RAIN-32), by mouth, 6 days every month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Milademetan (RAIN-32) is an experimental targeted therapy called a MDM2 inhibitor. Blocking MDM2 may help slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people with other types of cancer based on the kind of mutations or genes found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53, MDM2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05012397' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rainthera.com/pipeline' target='_blank'>Rain Therapeutics Drug Information Page: Milademetan (RAIN-32)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Cancer Center
Stanford,CA

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05126433

Lurbinectedin for Advanced HER2- Breast Cancer with a HRD Mutation

EMERGE-201: A Phase 2, Multicenter, Open-label Study of Lurbinectedin Efficacy and Safety in Participants With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

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

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a homologous recombination deficient (HRD) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lurbinectedin (Zepzelca®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lurbinectedin (Zepzelca®) is a chemotherapy approved for the treatment of other types of cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. It is enrolling people with other types of cancer based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HRD</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05126433' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zepzelca.com/' target='_blank'>Jazz Pharmaceuticals Drug Information Page: Lurbinectedin (Zepzelca®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/lurbinectedin-makes-a-splash-in-second-line-sclc' target='_blank'>OncLive: Lurbinectedin (Zepzelca®)</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 Health Care
Stanford,CA

VISITS: 1 visit every week

PHASE: I-II

NCT ID: NCT05259696

E-602 Immunotherapy for Advanced Breast Cancer

A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Cancers (GLIMMER-01) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of E-602, an experimental immunotherapy, alone and with pembrolizumab (Keytruda®).

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: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602 is an experimental type of immunotherapy that allows the body's immune system to detect and fight 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/NCT05259696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://palleonpharma.com/pipeline/' target='_blank'>Palleon Pharmaceuticals Drug Information Page: E-602</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: 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 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: 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 Cancer Center
Stanford,CA

VISITS: At least 1 visit every 2 months for the first year, then every 3 months thereafter

PHASE: I-II

NCT ID: NCT03215511

LOXO-195 in Patients With Advanced Cancer Whose Tumors Have An NTRK Mutation

A Phase 1/ 2 Study of the TRK Inhibitor LOXO 195 in Adult Subjects With NTRK Fusion (Previously Treated) or Non-Fusion NTRK Altered Cancers Scientific Title

Purpose

To test the safety and effects (good and bad) of LOXO-195.

Who is this for?

People with locally advanced (stage III) or metastatic (stage IV) breast cancer that has an NTRK mutation, have no other standard treatment options, and have been previously treated with a TRK inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-195 by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-195 is an investigational drug. </li> <li class="seamTextUnorderedListItem">It is a tyrosine-kinase inhibitor that binds to the TRK protein. </li> <li class="seamTextUnorderedListItem">Researchers believe it can stop cancer cell growth in tumors with an NTRK mutation.</li> <li class="seamTextUnorderedListItem">Mutations or deficiencies being studied: NTRK.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03215511' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/trk-inhibitor-loxo-195' target='_blank'>NCI Dictionary: LOXO-195</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Palo Alto,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04278144

BDC-1001 With or Without Keytruda for People With Advanced HER2 Positive Breast Cancer

Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and HER2-Expressing Solid Tumors Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of giving the new immunotherapy drug BDC-1001 alone and with the PD-1 inhibitor pembrolizumab (Keytruda®).

Who is this for?

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

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This is a 2-part study. Depending upon which part of the trial is open when you enroll, you will receive the following: Part 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> </ul> Part 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001 is an investigational drug called an Immune Stimulating Antibody Conjugate. It combines an anti-HER2 drug with a drug that targets the TLR7/8 proteins. </li> <li class="seamTextUnorderedListItem">Researchers think targeting the TLR7/8 proteins can help make tumors more likely to respond to pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Pembrolizumab is another type of immunotherapy called a PD-1 inhibitor. It works by getting the immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04278144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://boltbio.com/#ourscience' target='_blank'>Drug Company Information Page: BDC-1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytru' target='_blank'>Merck Oncology: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nationalbreastcancer.org/breast-cancer-targeted-therapy' target='_blank'>National Breast Cancer Foundation: Targeted Therapy (Monoclonal Antibodies)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Immune_stimulating_antibody_conjugate' target='_blank'>Wikipedia: Immune Stimulating Antibody Conjugate</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04691375

PY314 Alone or with Pembrolizumab in Metastatic HER2- Breast Cancer

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To determine the best dose, safety, and effects (good and bad) of PY314, an experimental targeted therapy, given alone or with Pembrolizumab (Keytruda®).

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received at least one treatment 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">PY314</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PY314</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PY314 is an experimental drug that targets TREM2, a protein found on some tumor cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 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 advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04691375' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/pionyr-immunotherapeutics-initiates-phase-1-clinical-study-of-py314-301175564.html' target='_blank'>Press Release: PY314</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pionyrtx.com/pipeline/py314/' target='_blank'>Pionyr Immunotherapeutics: PY314</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: 40 miles
St Joseph Health Medical Group - Napa
Napa,CA

VISITS: Please contact research site

PHASE: II

NCT ID: NCT05169437

Niraparib for Advanced Breast Cancer with a PALB2 Mutation

A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients With PALB2 Mutations Scientific Title

Purpose

To study the safety and effect of niraparib, an FDA-approved PARP inhibitor, in cancer types with a PALB2 mutation.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with an inherited or tumor PALB2 mutation. You must have already received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily</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">Niraparib (Zejula®) is approved to treat women with certain types of reproductive cancers. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">You cannot enroll in this trial If you have an inherited or tumor BRCA1 or BRCA2 mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05169437' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/parp-inhibitors-cancer/' target='_blank'>Metastatic Trial Talk: Get the Latest News on PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://zejula.com/' target='_blank'>GSK Drug Information Page: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tempus.com/news/tempus-announces-open-enrollment-for-study-in-collaboration-with-gsk-to-evaluate-niraparib-in-advanced-solid-tumor-patients-with-palb2-mutations/' target='_blank'>Tempus Laboratories Press Release: Niraparib in Advanced Solid Tumor Patients with PALB2 Mutations</a> </li></ul>

NEAREST SITE: 53 miles
St Joseph Heritage Healthcare
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04961996

Adjuvant Therapy with Giredestrant for Stage I, II, or III Estrogen Receptor-Positive, HER2-Negative 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 have had surgery. 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: 53 miles
St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare
Santa Rosa,CA

VISITS: 1 visit every 2-3 weeks

PHASE: III

NCT ID: NCT05382286

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced PD-L1 Positive, Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ASCENT-04) 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), with pembrolizumab (Keytruda®), a type of immunotherapy called a PD-1 inhibitor, compared to chemotherapy with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) PD-L1 positive (PD-L1+), triple negative (ER-, PR-, HER2-) 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 2 groups: Group 1: ADC with Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan-hziy (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Group 2: Chemotherapy with Immunotherapy <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> with: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan-hziy (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 an experimental 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">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/NCT05382286' 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/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</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://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation: Home</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: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,CA

VISITS: 3 visits a month, ongoing

PHASE: II

NCT ID: NCT04090398

Paclitaxel Alone or With Radium-223 Dichloride For Metastatic HER2 Negative Breast Cancer With Bone Metastases

Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of giving radium-223 dichloride (a type of radiation therapy given by IV) in combination with paclitaxel (Taxol®).

Who is this for?

People with metastatic (stage IV), HER2 negative (HER2-) breast cancer that has spread to the bone and who have not received more than three lines of chemotherapy for 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">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Radium 223 dichloride (Xofigo®), by IV, once a month, for 6 months</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Radium-223 dichloride (Xofigo®) is a radiation therapy given by IV. It works by killing cancer cells and may reduce the pain caused by bone metastases. </li> <li class="seamTextUnorderedListItem">Radium-223 dichloride (Xofigo®) is approved to treat metastatic prostate cancer that has spread to the bones. 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/NCT04090398' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/oral-vs-iv-paclitaxel-for-mbc' target='_blank'>Breastcancer.org: Is Oral Paclitaxel Better Than IV Paclitaxel for Metastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/radium-223-dichloride.aspx' target='_blank'>Chemocare: Radium 223 Dichloride</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Radium-223' target='_blank'>Wikipedia: Radium-223</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/bone-mets/' target='_blank'>Metastatic Breast Cancer Network: Bone Mets</a> </li></ul>

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

VISITS: 1 visit every week

PHASE: I-II

NCT ID: NCT04262466

IMC-F106C Immunotherapy for Advanced HLA and PRAME Positive Breast Cancer

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMC-F106C, an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HLA and PRAME positive breast cancer who have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMC-F106C, by IV or injection, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMC-F106C is an experimental immunotherapy called an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC®).</li> <li class="seamTextUnorderedListItem">An ImmTAC® is a T cell receptor (TCR) that activates the immune system to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA, PRAME</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04262466' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/clinical-trials/20-305' target='_blank'>Memorial Sloan Kettering Cancer Center: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?a=50&id=NCI-2020-02152&loc=0&ni=10&pn=69&rl=1' target='_blank'>National Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunocore.com/our-therapy-areas/oncology' target='_blank'>Immunocore Drug Information Page: IMC-F106C ImmTAC®</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/treatments/immunotherapy/cellular-immunotherapy/tcr-therapy/' target='_blank'>Moffitt Cancer Center: T-Cell Receptor (TCR) Therapy</a> </li></ul>

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

VISITS: 2 visits every 3 weeks for 4 months

PHASE: I

NCT ID: NCT04491942

Elimusertib Targeted Therapy with Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase I Trial of the ATR Inhibitor BAY 1895344 in Combination With Cisplatin and With Cisplatin Plus Gemcitabine in Advanced Solid Tumors With an Emphasis on Urothelial Carcinoma Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of elimusertib (BAY 1895344), an experimental ATR inhibitor, with cisplatin (Platinol®) and gemcitabine (Gemzar®) chemotherapies.

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">Elimusertib (BAY 1895344), by mouth, weekly, 2 weeks on, 1 week off for 4 months</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®), by IV, weekly, 2 weeks on, 1 week off for 4 months</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off for 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elimusertib (BAY 1895344) is an experimental targeted therapy called an ATR inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) and gemcitabine (Gemzar®) are chemotherapy drugs that stop the growth of tumor cells by killing the 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/NCT04491942' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mycancergenome.org/content/drugs/elimusertib/' target='_blank'>My Cancer Genome/Vanderbilt-Ingram Cancer Center: Elimusertib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/newsroom/therapies-targeting-dna-damage-response-show-promising-antitumor-activity.h00-159538956.html' target='_blank'>MD Anderson Cancer Center: Elimusertib for Advanced Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 75 miles
Sutter Medical Center Sacramento
Sacramento,CA

VISITS: Please contact research site

PHASE: III

NCT ID: NCT04588246

Stereotactic Radiotherapy Alone or with Whole Brain Radiotherapy (Excluding the Hippocampus) & a Dementia Medication for Brain Mets that Returned After Stereotactic Radiotherapy

Phase III Trial of Salvage Stereotactic Radiosurgery (SRS) or SRS + Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for First or Second Distant Brain Relapse After Upfront SRS With Brain Metastasis Velocity >/= 4 Brain Metastases/Year Scientific Title

Purpose

To compare the anti-cancer activity and side effects of giving stereotactic radiation therapy alone to giving it with an anti-dementia drug and whole-brain radiation therapy that avoids the hippocampus.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to their brain and who have already received stereotactic radiation therapy for brain 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">Memantine, by mouth, once or twice a day, for 6 months</li> <li class="seamTextUnorderedListItem">Whole brain radiation therapy, 10 times over 2 weeks</li> <li class="seamTextUnorderedListItem">folowed by, stereotactic radiotherapy</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiotherapy</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/NCT04588246' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/brain-metastases-radiation-therapy-hippocampal-avoidance' target='_blank'>NCI Cancer Currents Blog: Tailored Radiation to Treat Brain Metastases Reduces Impact on Cognitive Function</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/side-effects-of-brain-mets-radiation/' target='_blank'>Metastatic Trial Talk: Side Effects of Radiation Therapy to the Brain</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a604006.html' target='_blank'>MedLinePlus: Memantine</a> </li></ul>

NEAREST SITE: 158 miles
California Cancer Associate for Research & Excellence
Fresno,CA

VISITS: 1 visit every 3 weeks, for 10 months

PHASE: III

NCT ID: NCT04873362

Additional Treatment for People with Stage I-III HER2+ Breast Cancer Who had Tumor Remaining after Receiving Treatment Before Surgery

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Scientific Title

Purpose

To study and compare the anti-cancer activity, side effects, and safety of giving trastuzumab emtansine (Kadcyla®) alone or with atezolizumab (Tecentriq®) after neoadjuvant therapy and surgery.

Who is this for?

People with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who received chemotherapy and an anti-HER2 targeted therapy before surgery (neoadjuvant treatment). During surgery, your doctors must have found remaining tumor or cancer cells in your breast or lymph nodes (residual disease). Additionally, you must not have already received trastuzumab emtansine, atezolizumab, or any other checkpoint 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">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 10 months</li> <li class="seamTextUnorderedListItem">Placebo for atezolizumab (Tecentriq®), by IV, every 3 weeks, for 10 months. </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 10 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, for 10 months.</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">Residual disease is when, during surgery, doctors find some remaining tumor in the breast or lymph nodes of a person who received neoadjuvant therapy. </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody — the HER2-targeted therapy trastuzumab — to deliver the chemotherapy DM1 directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor or a checkpoint inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04873362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/atezolizumab.aspx' target='_blank'>Chemocare: Atezolizumab (Tecentriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2020/residual-cancer-burden-is-prognostic-of-outcomes-across-breast-cancer-subtypes/' target='_blank'>The ASCO Post: Residual Cancer Burden Is Prognostic of Outcomes Across Breast Cancer Subtypes</a> </li></ul>

NEAREST SITE: 159 miles
California Oncology of the Central Valley
Fresno,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: 186 miles
Renown Health
Reno,NV

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05065411

Enobosarm With Abemaciclib for Metastatic AR+, ER+, HER2- Breast Cancer

P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of enobosarm, an experimental type of hormone therapy called a SARM, with abemaciclib (Verzenio®), a type of targeted therapy called a CDK 4/6 inhibitor, compared to standard hormone treatment.

Who is this for?

People with metastatic (stage IV), androgen receptor positive (AR+), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that has progressed on hormone therapy plus palbociclib (Ibrance®). 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">Enobosarm, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2: Standard care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, or fulvestrant (Faslodex®), by injection, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enobosarm is an experimental type of hormone therapy called a selective androgen receptor modulator (SARM) that targets the androgen receptor (AR).</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> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that block some production of estrogen 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">Mutations or targets: AR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05065411' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://verupharma.com/pipeline/enobosarm-for-breast-cancer/' target='_blank'>Veru Pharma Drug Information Page: Enobosarm</a> </li><li class='seamTextUnorderedListItem'><a href='https://verupharma.com/pipeline/enobosarm-abemaciclib-combination-therapy-for-breast-cancer/' target='_blank'>Veru Pharma Drug Information Page: Enobosarm + Abemaciclib Combination Therapy for Breast Cancer</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#section-types-of-hormonal-therapy' target='_blank'>Breastcancer.org: Aromatase Inhibitors</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: 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

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-hziy (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-hziy (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>

NEAREST SITE: 252 miles
Research Site
Solvang,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04711252

CDK4/6 Inhibitor Palbociclib with AZD9833 or an Aromatase Inhibitor for Metastatic, ER+, HER2- Breast Cancer

SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease Scientific Title

Purpose

To compare the anti-cancer activity of using the experimental anti-estrogen therapy AZD9833 to the aromatase inhibitor anastrazole (Arimidex®) when giving in combination with a CDK 4/6 inhibitor.

Who is this for?

People with metastatic (stage IV), estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer who have not already received a CDK 4/6 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">AZD9833, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for anastrozole (Arimidex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for AZD9833, 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">AZD9833 is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degraded).</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®). Fulvestrant is given by injection.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is a type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early-stage and metastatic hormone-positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with approved anti-estrogen therapies for metastatic HR+, HER2- breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/new-strategies-shift-landscape-in-hr-metastatic-breast-cancer' target='_blank'>OncLive: New Strategies Shift Landscape in HR+ Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.1024' target='_blank'>ASCO Abstract: Next Generation Oral SERD AZD9833 in Women with ER-Positive, HER2-Negative Advanced Breast Cancer</a> </li></ul>

NEAREST SITE: 317 miles
Asante Rogue Regional Medical Center
Medford,OR

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04188548

LY3484356 Alone or With Abemaciclib in Advanced ER+, HER2- Breast Cancer

A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Abemaciclib to Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of LY3484356 when it is given alone or with abemaciclib (Verzenio®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that has been treated with at least one standard of care 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">LY3484356, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3484356, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> </ul> Please contact research site for treatment schedule Additional procedures: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies (tissue samples)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3484356 is an experimental drug. </li> <li class="seamTextUnorderedListItem">Verzenio® is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved to treat metastatic ER+ and/or PR+, HER2- breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04188548' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lillytrialguide.com/en-US/studies/breast-cancer/jzla' target='_blank'>Eli Lilly & Company Study Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/?utm_source=google&utm_medium=ppc&campaign=6456675261&adgroup=82640243172&ad=378689406880&utm_keyword=kwd-389189556877&gclid=CjwKCAiA1L_xBRA2EiwAgcLKA1TCNjqFBHZ6GUcDnbYuJPCiPuF9GkpS2yp7gF3j1LJCZnLEMhSm_RoCO0QQAvD_BwE' target='_blank'>Eli Lilly & Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li></ul>

NEAREST SITE: 326 miles
Kaiser Permanente
Woodland Hills,CA

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT04622319

Antibody-Drug Conjugate before Surgery for Stage I-III, HER2+ Breast Cancer Already Treated with Chemo & an Anti-HER2 Therapy

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05) Scientific Title

Purpose

To compare the anti-cancer activity of two antibody-drug conjugates -- trastuzumab deruxtecan-nxki (Enhertu®) and trastuzumab emtansine/T-DM1 (Kadcyla®).

Who is this for?

People with stage I, stage II or stage III HER2 positive (HER2+) breast cancer who received chemotherapy and an anti-HER2 targeted therapy before surgery. Remaining cancer cells must have been found in your breast or lymph nodes during 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">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy and anti-HER2 targeted therapy (treatment given before surgery) are used to shrink tumors and to see how cancer responds to certain treatments. </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">This trial is for people who still had some tumor remaining at the time of surgery. </li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets the HER2 protein on cancer cells 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, but 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 deliver the chemotherapy DM1 directly to the cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04622319' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-approves-enhertu-for-her2-pos-mbc' target='_blank'>Breastcancer.org: FDA Approves Enhertu for Unresectable or Pretreated Metastatic HER2-Positive Breast Cancer</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></ul>

NEAREST SITE: 330 miles
Synergy Hematology Oncology
Encino,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03382340

IMX-110 for Advanced Breast Cancer

A Phase 1/2a Open-Label, Dose-Escalation/Dose-Expansion Safety, Tolerability and Pharmacokinetic Study of IMX-110 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of IMX-110, an experimental targeted therapy.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMX-110</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMX-110 is made up of a tyrosine kinase inhibitor that targets the Stat3 and NF-kB proteins and the chemotherapy doxorubicin. </li> <li class="seamTextUnorderedListItem">This study also is 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/NCT03382340' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nccn.org/patients/resources/life_with_cancer/treatment/targeted_therapy.aspx' target='_blank'>National Comprehensive Cancer Network: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://emedicine.medscape.com/article/1947145-medication#9' target='_blank'>MedScape: Tyrosine Kinase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/22339066' target='_blank'>Journal Article Abstract: Doxorubicin-loaded Nanoparticles: New Advances in Breast Cancer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='http://immixbio.com/pipeline/' target='_blank'>Drug Company Information Page: IMX-110</a> </li></ul>

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>

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> <li class="seamTextUnorderedListItem">2 biopsies</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>

NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
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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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>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04244552

ATRC-101 (An Experimental Immunotherapy) for Advanced Breast Cancer

A First-in-Human Phase 1b Dose Escalation Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATRC-101 in Adults With Advanced Solid Malignancies Scientific Title

Purpose

To study the safety and effects (good and bad) of the experimental immunotherapy ATRC-101.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) 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">ATRC-101</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ATRC-101 is a new drug that is designed to get the immune system to see and attack cancer cells. </li> <li class="seamTextUnorderedListItem">It is also believed to change the microenvironment (the area that surrounds the cancer cells), which may make it easier for the immune cells to kill the cancer cells.</li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of solid cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04244552' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.atreca.com/pipeline/' target='_blank'>Drug Company Information Page: ATRC-101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/immunotherapy.html' target='_blank'>American Cancer Society: Immunotherapy for Breast Cancer</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04485013

Experimental Immunotherapy for Advanced Breast Cancer that Expresses HLA-G

A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, side effects and anti-tumor activity of the experimental immunotherapy TTX-080.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose tumor expresses HLA-G. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-080, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TTX-080 is an experimental immunotherapy that researchers believe works by blocking the cancer cell protein HLA-G.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer that expresses HLA-G. </li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA-G</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04485013' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tizonatx.com/science/' target='_blank'>Tizona Therapeutics Drug Information Page: TTX-080</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2020.01685/full' target='_blank'>Journal Article: HLA-G Neo-Expression on Tumors</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04553770

Trastuzumab Deruxtecan Alone or With Hormone Therapy for Stage II-III HER2 Low, HR Positive Breast Cancer

A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting Scientific Title

Purpose

To study and compare the anti-cancer acitivity and safety of giving trastuzumab deruxtecan-nxki (Enhertu®) alone or with the anti-estrogen therapy anastrozole (Arimidex®) before surgery (neoadjuvant).

Who is this for?

People with stage II or stage III hormone positive (ER+ and/or PR+), HER2 low expression (defined below) breast cancer whose tumor is 2 cm or larger and who have not yet started treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and recieve the following before surgery: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, for 4.5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a chemotherapy directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early stage and metastatic hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04553770' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab_deruxtecan' target='_blank'>Wikipedia: Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020%3bs%3bph%3bbr%3bonc%3bhcp%3bbr&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqia48j9brc-arisamqu3wqel0xz_rkoi7g8nk-ckknd1pfqh_i4wknawmwg' target='_blank'>Daiichi-Sankyo Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing, A New Subcategory of HER2 Negative Breast Cancer?</a> </li></ul>

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

VISITS: 1 visit every week for 7 weeks, then 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04916002

Two Immunotherapies for Advanced Triple Negative Breast Cancer

A Multicenter, Open-label, Phase 2 Study of Intratumoral CMP-001 in Combination With an Intravenous PD-1-Blocking Antibody in Subjects With Selected Types of Advanced or Metastatic Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of vidutolimod (CMP-001), an experimental immunotherapy, with cemiplimab-rwlc (Libtayo®), an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has been treated with up to 5 lines of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vidutolimod (CMP-001), by injection, weekly for 7 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Cemiplimab-rwlc (Libtayo®), by IV, every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vidutolimod (CMP-001) is an experimental immunotherapy that stimulates immune cells called T cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Cemiplimab-rwlc (Libtayo®) is a type of immunotherapy called an immune checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">Cemiplimab-rwlc (Libtayo®) is approved for treatment of other cancers. 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/NCT04916002' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://checkmatepharma.com/our-science/vidutolimod-platform-technology/' target='_blank'>Checkmate Pharmaceuticals Drug Information Page: Vidutolimod (CMP-001)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.libtayo.com/' target='_blank'>Regeneron/Sanofi Drug Information Page: Cemiplimab-rwlc (Libtayo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

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

VISITS: 1 visit every week

PHASE: I-II

NCT ID: NCT05319873

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breas... Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®), trastuzumab (Herceptin®), and tucatinib (Tukysa®) targeted therapies alone or with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) or HER2 low breast cancer. If you have stage II or some stage III breast cancer, you must not have received treatment or surgery. If you have advanced (some stage III) or metastatic (stage IV) breast cancer, you must have received at least 1 line of anti-HER2 targeted therapy for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on your type of cancer: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. It blocks two enzymes, CDK 4 and CDK 6, that help cancer cells grow.</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">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</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">In this trial, HER2 low is defined as IHC 2+.</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/NCT05319873' target='_blank'>ClinicalTrials.gov</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/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</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: 336 miles
University of California - Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05511844

ORM-5029 Antibody Drug Conjugate for HER2 Positive or HER2 Low Breast Cancer

Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ORM-5029, an experimental antibody drug conjugate.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low (IHC 1+) 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">ORM-5029, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORM-5029 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 HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called a GSPT1 protein degrader.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 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/NCT05511844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.orumrx.com/pipeline-platform' target='_blank'>Orum Therapeutics Drug Information Page: ORM-5029</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.businesswire.com/news/home/20221031005031/en/Orum-Therapeutics-Announces-First-Patient-Dosed-in-Phase-1-Clinical-Trial-of-ORM-5029-in-Development-to-Treat-HER2-Expressing-Advanced-Solid-Tumors' target='_blank'>Orum Therapeutics Press Release: ORM-5029</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: 339 miles
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03674567

Immunotherapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer Scientific Title

Purpose

To look at the best dose, safety and effects (good and bad) of using FLX475 alone or with pembrolizumab (Keytruda®).

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475 is an investigational targeted therapy that helps the immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 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/NCT03674567' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.flxbio.com/next-generation-immune-modulators/flx475/' target='_blank'>Sponsor site: FLX475</a> </li></ul>

NEAREST SITE: 339 miles
Providence Saint John's Health Center
Santa Monica,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04246671

Experimental Vaccine for Advanced HER2 Positive Breast Cancer

Phase 1/2 Expansion Cohorts Trial of Intravenous Administration of TAEK-VAC-HerBy Vaccine Alone and in Combination With HER2- and PD-1/PD-L1 Antibodies in Patients With Advanced HER2-expressing Cancer Scientific Title

Purpose

To study the safety, anti-cancer activity and effects (good and bad) of giving an experimental vaccine called TAEK-VAC-HerBy alone or in combination with other therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already received at least one therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vaccine (TAEK-VAC-HerBy), by IV, every 3 weeks, 3 times</li> </ul> With or without one or more of the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> <li class="seamTextUnorderedListItem">a PD-1/PD-L1 inhibitor, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAEK-VAC-HerBy is the experimental vaccine used in this trial. Researchers believe it may stimulate the immune system to go after HER2 positive cancer cells.</li> <li class="seamTextUnorderedListItem">Other therapies you may receive during this trial include: trastuzumab (Herceptin®), T-DM1 (Kadcyla®), pertuzumab (Perjeta®), and a PD-1/PD-L1 inhibitor.</li> <li class="seamTextUnorderedListItem">Trastuzumab and pertuzumab are anti-HER2 targeted therapies commonly used to treat advanced HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">T-DM1 is an antibody-drug conjugate (ADC). It uses the HER2-targeted therapy trastuzumab to deliver the chemotherapy DM1 directly to cancer cells.</li> <li class="seamTextUnorderedListItem">PD-1/PD-L1 inhibitors are a type of immunotherapy. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04246671' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/taek-vac-herby-vaccine?redirect=true' target='_blank'>NCI Drug Dictionary: TAEK-VAC-HerBy Vaccine</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://metastatictrialtalk.org/research-news/her2-positive-breast-cancer-research-update/' target='_blank'>Metastatic Trial Talk: HER2 Positive Metastatic Breast Cancer Research Update</a> </li></ul>

NEAREST SITE: 339 miles
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04503265

Dual PARP and Microtubule Polymerization Inhibitor AMXI-5001 for Advanced Breast Cancer.

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies Scientific Title

Purpose

To study the best dose, safety, and anti-cancer activity of AMXI-5001--an experimental PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) 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">AMXI-5001, by mouth, twice daily (4 days on, 3 days off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMX-5001 is an experimental PARP inhibitor.</li> <li class="seamTextUnorderedListItem">PARP inhibitors block poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their 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/NCT04503265' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://atlasmedx.com/product-pipeline/' target='_blank'>AtlasMedx Drug Information Page: AMXI-5001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/parp-inhibitor' target='_blank'>NCI Drug Dictionary: PARP Inhibitor</a> </li></ul>

NEAREST SITE: 339 miles
John Wayne Cancer Institute, Providence Saint John's Health Center
Santa Monica,CA

VISITS: 1 visit that coincides with surgery

PHASE: NA

NCT ID: NCT04603209

A Registry and IORT Radiation Therapy During Lumpectomy for DCIS and Stage I-III Breast Cancer

Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer Scientific Title

Purpose

To develop a registry that will allow researchers to study and compare the long-term safety and anti-cancer activity of giving one dose of radiation therapy (IORT) during a lumpectomy to standard of care radiation therapy.

Who is this for?

People with DCIS, stage I, stage II, or stage III breast cancer who are planning to have a lumpectomy (breast conserving surgery). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IORT (Intraoperative radiation therapy), one time during lumpectomy (breast conserving surgery)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy. </li> <li class="seamTextUnorderedListItem">Typically, a lumpectomy (breast conserving surgery) is followed by 4 to 6 weeks of daily radiation therapy.</li> <li class="seamTextUnorderedListItem">In this trial, you will receive intraoperative radiation therapy (IORT) one time during your lumpectomy. </li> <li class="seamTextUnorderedListItem">IORT delivers a high dose of radiation during surgery to the area in the breast where the tumor was removed. This means you only receive one dose, and it may cause less damage to the healthy tissue around the tumor. </li> <li class="seamTextUnorderedListItem">This trial will also create a data registry of people receiving IORT so that researchers can study the long-term safety and anti-cancer activity of this type of radiation therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04603209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20131203' target='_blank'>Breastcancer.org: Studies Show Risks and Benefits of Intraoperative Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/cancer/npcr/value/registries.htm' target='_blank'>CDC: How Cancer Registries Work</a> </li></ul>

NEAREST SITE: 339 miles
Providence St. Johns Health Center
Santa Monica,CA

VISITS: Every 2 weeks for 1 month, then monthly

PHASE: I

NCT ID: NCT04851613

Afuresertib With Fulvestrant for Advanced HR+, HER2- Breast Cancer

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of afuresertib (LAE002), an experimental type of targeted therapy called an AKT inhibitor, with fulvestrant (Faslodex®), a type of hormone therapy called a SERD.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has progressed after 1 or 2 lines of treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Afuresertib (LAE002), by mouth, daily, ongoing or three weeks on, one week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Afuresertib (LAE002) 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">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">Premenopausal and perimenopausal women will also be given a drug that will put you 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/NCT04851613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.saintjohnscancer.org/clinical-trials/clinical-trial/study-evaluating-efficacy-safety-of-afuresertib-plus-fulvestrant-in-patients-w-locally-advanced-or-metastatic-hr-her2-breast-cancer/' target='_blank'>Saint John’s Cancer Institute: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/laekna-therapeutics-receives-ind-approvals-in-china-and-us-for-phase-ibiii-global-multi-center-clinical-study-of-afuresertib-in-combination-with-fulvestrant-for-patients-with-hrher2--breast-cancer-301364146.html' target='_blank'>Laekna Therapeutics Press Release: Afuresertib With Fulvestrant for Advanced HR+, HER2- Breast Cancer</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: 339 miles
University of California, Los Angeles
Santa Monica,CA

VISITS: 2 visits per month

PHASE: I

NCT ID: NCT04890613

CX-5461 for Advanced Breast Cancer with a BRCA2 or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation Scientific Title

Purpose

To determine the safety and best dose of CX-5461, an experimental targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have a BRCA2 or PALB2 germline (genetic) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461, by IV, 2 times per month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 is an experimental targeted therapy. </li> <li class="seamTextUnorderedListItem">It targets cells with a Homologous Recombination Deficiency (HRD) mutation. </li> <li class="seamTextUnorderedListItem">It works by slowing down the growth of cancer cells or causing cancer cells to die.</li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA2, PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04890613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/senhwa-biosciences-receives-us-fda-study-may-proceed-letter-to-treat-brca2-or-palb2-solid-tumors-with-cx-5461-301198347.html' target='_blank'>Senhwa Biosciences Press Release: CX-5461</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Medical Center
Santa Monica,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT04913337

NGM707 With or Without Pembrolizumab in Advanced or Metastatic Breast Cancer

A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of NGM707 when given with and without Pembrolizumab (Keytruda®).

Who is this for?

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

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You will be assigned to one of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM707, by IV, every 3 weeks </li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM707, by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM707 is designed to improve immune responses to tumors.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 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/NCT04913337' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/ngm-bio-announces-initiation-of-phase-1-2-clinical-study-of-ngm707-for-the-treatment-of-advanced-solid-tumors/' target='_blank'>NGM Bio Press Release: NGM707</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/?preview_id=1346&preview_nonce=680d60f386&post_format=standard&_thumbnail_id=252&preview=true' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 339 miles
Providence Saint John's Health Center
Santa Monica,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: 339 miles
UCLA Medical Center / David Geffen School of Medicine
Santa Monica,CA

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT05132582

Tucatinib, Trastuzumab, and Pertuzumab Targeted Therapies for Advanced HER2+ Breast Cancer (HER2CLIMB-05)

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of tucatinib (Tukysa®), trastuzumab (Herceptin®) , and pertuzumab (Perjeta®) anti-HER2 targeted therapies compared to trastuzumab (Herceptin®) and pertuzumab (Perjeta®) alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer with and without evidence of disease. You must have received treatment with trastuzumab (Herceptin®), pertuzumab (Herceptin®), and a taxane chemotherapy as your first line 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">Tucatinib (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for tucatinib (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging scans, every 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), trastuzumab (Herceptin®), and pertuzumab (Perjeta®) are anti-HER2 targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">The placebo is a pill that looks the same as tucatinib (Tukysa®) but does not contain the medication.</li> <li class="seamTextUnorderedListItem">Some blood tests may be completed locally instead of at the trial research site.</li> <li class="seamTextUnorderedListItem">The imaging scan costs are covered by the clinical trial.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05132582' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.her2climb05.com/' target='_blank'>Seagen: Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancer.org: Pertuzumab (Perjeta®)</a> </li></ul>

NEAREST SITE: 339 miles
The Angeles Clinic
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05215574

NGM831 with Pembrolizumab for Advanced Breast Cancer

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of NGM831, an experimental immunotherapy, alone and with pembrolizumab (Keytruda®) 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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What's being studied?
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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831 is an experimental immunotherapy called an ILT3 inhibitor.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking ILT3 and PD-1 may allow 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/NCT05215574' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.ngmbio.com/news-releases/news-release-details/ngm-bio-discloses-fourth-oncology-development-candidate-ngm831' target='_blank'>NGM Bio Press Release: NGM831</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: 339 miles
University of California, Los Angeles
Los Angeles,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: 339 miles
Providence Saint John's Hospital
Santa Monica,CA

VISITS: May require hospitalization

PHASE: NA

NCT ID: NCT05289466

Intraoperative Radiotherapy During Partial Mastectomy for Women Ages 50+ with Recurrent DCIS or Stage I-III Breast Cancer

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of intraoperative radiotherapy (IORT) during a partial mastectomy after recurrence.

Who is this for?

Women ages 50 and older with DCIS, stage I, some stage II, or some stage III node negative breast cancer that has recurred within 1 year who have received radiation therapy. You must not be receiving any neoadjuvant (before surgery) treatment, except for radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiotherapy (IORT), 1 time</li> <li class="seamTextUnorderedListItem">Partial mastectomy</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiotherapy (IORT) is radiation given at the time of a partial mastectomy.</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> <li class="seamTextUnorderedListItem">A partial mastectomy is surgery to remove part of the breast and is sometimes called a lumpectomy.</li> <li class="seamTextUnorderedListItem">Node negative means cancer has not spread to your lymph nodes.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with lobular breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05289466' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy/intraoperative' target='_blank'>Breastcancer.org: Intraoperative Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/surgery/breast-reconstruction/types/oncoplastic-lumpectomy' target='_blank'>Breastcancer.org: Partial Mastectomy</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Division of Hematology-Oncology
Los Angeles,CA

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT05395052

FT536 NK Cell Therapy for Advanced Triple Negative or HER2+ Breast Cancer

A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and best dose of FT536, an experimental immunotherapy called a NK cell therapy, with immunotherapy or targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- HER2-), HER2 low (IHC 2+), or HER2 positive (HER2+) breast cancer that has progressed on standard treatment. If your cancer is triple negative, it must also be PD-L1 positive (PD-L1+). Full eligibility criteria

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You will be assigned to 1 of 3 groups based on your type of cancer: Group 1: NK Cell Therapy with Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT536 NK cell therapy</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> <li class="seamTextUnorderedListItem">IL-2</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®)</li> </ul> Group 2: NK Cell Therapy with 3 Immunotherapies <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT536 NK cell therapy</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> <li class="seamTextUnorderedListItem">IL-2</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®)</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®)</li> </ul> Group 3: NK Cell Therapy with Targeted Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT536 NK cell therapy</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> <li class="seamTextUnorderedListItem">IL-2</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT536 is an experimental immunotherapy called a natural killer (NK) cell therapy.</li> <li class="seamTextUnorderedListItem">NK cells are specialized immune cells that can fight cancer cells.</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), pembrolizumab (Keytruda®), nivolumab (Opdivo®), and atezolizumab (Tecentriq®) are types of immunotherapy called PD-1/PD-L1 inhibitors, which is a type of immune checkpoint inhibitor. Blocking PD-1/PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of HER2 targeted therapy.</li> <li class="seamTextUnorderedListItem">IL-2 is a type of immunotherapy that activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Before you receive FT538 NK cell therapy, you will be given the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). These drugs are given to prepare your immune system to receive the NK cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2+ is defined as IHC 2+ or 3+.</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/NCT05395052' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://fatetherapeutics.com/pipeline/immuno-oncology-candidates/ft536/' target='_blank'>Fate Therapeutics Drug Information Page: FT536</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/car-nk-therapy-offers-new-treatment-option-for-blood-cancers.h00-159379578.html' target='_blank'>MD Anderson Cancer Center: NK Cell Therapy</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><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/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li></ul>

NEAREST SITE: 340 miles
Valkyrie Clinical Trials
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05414123

CNSide Test to Monitor Treatment Response and Make Treatment Decisions in People with Leptomeningeal Metastases

A Longitudinal Therapy Response Monitoring Study in Subjects With Leptomeningeal Metastases Using CNSide (CSF Tumor Cells) Compared to Standard of Care (CSF Cytology, Clinical Evaluation, and Imaging). Scientific Title

Purpose

To study the ability of the CNSide test to monitor treatment responses and help doctors make treatment decisions for leptomeningeal metastasis.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the leptomeninges (leptomeningeal metastasis). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lumbar puncture to collect CSF</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">The CNSide test can detect and measure tumor cells in CSF.</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/NCT05414123' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://biocept.com/cnside-assay/' target='_blank'>Biocept: CNSide Test</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/lumbar-puncture/about/pac-20394631#:~:text=A%20lumbar%20puncture%20(spinal%20tap)%20is%20a%20test%20used%20to,a%20sample%20of%20cerebrospinal%20fluid.' target='_blank'>Mayo Clinic: Lumbar Puncture</a> </li></ul>

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 3 visits every month, ongoing

PHASE: I

NCT ID: NCT03129139

Minnelide™ Capsules and Chemotherapy for Metastatic Breast Cancer

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using Minnelide™ along with the chemotherapy protein-bound paclitaxel (Abraxane®).

Who is this for?

People with metastatic (stage IV) breast cancer and have no standard cancer treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Minnelide™, by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Abraxane® (protein-bound paclitaxel), by IV, once a week (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Minnelide™ is an experimental heat shock protein (HSP) inhibitor. </li> <li class="seamTextUnorderedListItem">Abraxane is used to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03129139' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/protein-bound-paclitaxel' target='_blank'>NCI Dictionary of Cancer Terms: Protein-bound Paclitaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/triptolide-analogue' target='_blank'>NCI Drug Dictionary: Triptolide Analogue (Minnelide™)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4515388/' target='_blank'>Journal Article: Minnelide™ for Pancreatic and Liver Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abraxane.com/mbc/' target='_blank'>Drug Company Information Page: Abraxane</a> </li></ul>

NEAREST SITE: 341 miles
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles,CA

VISITS: Visits every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03310957

SGN-LIV1A and Immunotherapy for Advanced Triple Negative Breast Cancer

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using SGN-LIV1A--an experimental antibody-drug conjugate--in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), 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.</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">SGN-LIV1A is an antibody-drug conjugate. Its antibody targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and it delivers an anti-cancer drug called monomethyl auristatin E.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03310957' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/pipeline/ladiratuzumab-vedotin' target='_blank'>Seagen Drug Information Page: Ladiratuzumab Vedotin (SGN-LIV1A)</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.keytruda.com' target='_blank'>Merck Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

100

NEAREST SITE: 341 miles
Cedars Sinai Medical Center
Los Angeles,CA

VISITS: Weekly visits for 3 months

PHASE: II

NCT ID: NCT03747120

Chemotherapy, HER2 Targeted Therapy, & Immunotherapy Before Surgery in HER2+ Breast Cancer

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP) Scientific Title

Purpose

To compare the safety and effects (good and bad) of three different breast cancer treatment regimens that will be given before breast cancer surgery.

Who is this for?

People with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who have not yet received any treatment for breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Taxol/Herceptin/Perjeta (THP) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks, for 3 months</li> </ul> Group 2: Taxol/Herceptin/Perjeta-Keytruda (THP-K) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Same treatment as Group 1 plus:</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 3 months</li> </ul> Group 3: Taxol/Herceptin-Keytruda (TH-K) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 3 months</li></ul>
The drugs used in different combinations for treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ttrastuzumab (Herceptin®), a HER2-targeted therapy </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), a HER2-targeted therapy</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), an immunotherapy</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), a chemotherapy</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03747120' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/Trastuzumab.html' target='_blank'>Susan G. Komen: Targeted Therapies for HER2-Positive Early Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/issues/december-10-2018/management-of-her2-positive-breast-cancer/' target='_blank'>ASCO Post: Management of HER2-Positive Breast Cancer: Business as Usual?</a> </li></ul>

101

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: May require hospitalization

PHASE: III

NCT ID: NCT04365374

Gamma Tile Surgically Targeted Radiation Therapy after Brain Surgery for Brain Metastasis

A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors. Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of Gamma Tile Surgically Targeted Radiation Therapy (STaRT) and stereotactic radiation after brain surgery.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis). You must have 1-4 brain tumors that have not been treated with radiation. 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">Brain surgery to remove tumor and implant Gamma Tile device</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gamma Tile Surgically Targeted Radiation Therapy (STaRT)</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain surgery to remove tumor</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cognitive testing</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gamma Tile Surgically Targeted Radiation Therapy (STaRT) is a FDA-cleared radiation therapy.</li> <li class="seamTextUnorderedListItem">Gamma Tile is a device implanted during surgery that delivers radiation directly to the tumor, called Surgically Targeted Radiation Therapy (STaRT).</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">Additional brain tumors not removed during surgery will be treated with stereotactic radiation alone, which is standard of care.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04365374' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

102

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 1 visit every 6 months (coincides with standard follow up visits), for up to 7 years

PHASE: II

NCT ID: NCT04567420

A ctDNA Blood Test to Screen for Recurrence for Stage II-III ER+, HER2- Breast Cancer

A Randomized Phase II Trial Of Circulating Tumor DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity, safety, and side effects of using a ctDNA blood test to guide treatment decisions in people who are taking anti-hormone therapy after surgery.

Who is this for?

People with stage II or stage III estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer. You must be taking an anti-hormone therapy after surgery, and your cancer must be considered at high risk for recurrence (coming back). See below for the definition of high-risk. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA blood test, every 4 to 6 months, for up to 7 years</li> </ul> If a ctDNA blood test is positive, you will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your current anti-hormone therapy (an aromatase inhibitor or tamoxifen)</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">Researchers are studying if a test looking for ctDNA in the bloodstream can determine if there will be a recurrence (coming back) of a person's breast cancer. </li> <li class="seamTextUnorderedListItem">The ctDNA blood test used in this trial is called Signatera. </li> <li class="seamTextUnorderedListItem">This trial is also studying if a recurrence can be stopped or delayed by giving people with a positive ctDNA test additional treatment.</li> <li class="seamTextUnorderedListItem">The additional treatment in this trial includes Palbociclib (Ibrance®) and Fulvestrant (Faslodex®).</li> <li class="seamTextUnorderedListItem">Palbociclib 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">Fulvestrant is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader). It is approved to treat some people with advanced HR+ breast cancer.</li> <li class="seamTextUnorderedListItem">For this trial, some of the definitions of cancer at high risk of recurrence include: </li> <li class="seamTextUnorderedListItem">Cancer found in 4 or more lymph nodes, or </li> <li class="seamTextUnorderedListItem">A tumor 5 cm or larger, or</li> <li class="seamTextUnorderedListItem">Cancer found in 1 to 3 lymph nodes, and your tumor was at least 3 cm, or grade 3 or, your Oncotype DX score was greater than 26, MammaPrint score was high risk, EndoPredict was greater than 4, or Prosigna score was greater than 60.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04567420' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>What is Circulating Tumor DNA and How is it Used to Diagnose and Manage Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.natera.com/oncology/signatera-advanced-cancer-detection/' target='_blank'>Natera ctDNA Test Information Page: Signature</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2021/a-tale-of-two-cdk46-inhibitors-in-early-breast-cancer/' target='_blank'>The ASCO Post: A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer</a> </li></ul>

103

NEAREST SITE: 341 miles
Beverly Hills Cancer Center
Beverly Hills,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04577963

Targeted Therapy and Immunotherapy for Advanced Triple Negative Breast Cancer

An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of giving a VEGFR inhibitor along with immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer who have not received more than three chemotherapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fruquintinib, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Tislelizumab, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fruquintinib is a tyrosine kinase inhibitor designed to block the protein VEGFR (vascular endothelial growth factor receptor). Tumors use VEGFR to grow new blood vessels. Research suggests VEGFR inhibitors may slow or stop cancer cell growth.</li> <li class="seamTextUnorderedListItem">Tislelizumab is an experimental type of immunotherapy called a PD-1 inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04577963' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/en-us/science-and-product-portfolio/pipeline/tislelizumab' target='_blank'>BeiGene Drug Information Page: Tislelizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fruquintinib' target='_blank'>NCI Drug Dictionary: Fruquintinib</a> </li></ul>

104

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
West Hollywood,CA

VISITS: Number of visits unavailable, ongoing

PHASE: I

NCT ID: NCT04580485

INCB106385 Alone or With an Experimental Immunotherapy for Advanced Triple Negative Breast Cancer with a Certain Biomarker

A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, side effects and anti-cancer activity of giving the experimental therapy INCB106385 alone or with the experimental immunotherapy INCMGA00012.

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 of care treatment options available and who have CD8 T-cell positive tumors. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB106385, by mouth, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB106385, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">INCMGA00012, by IV, every month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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/NCT04580485' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.incyte.com/what-we-do/pharmaceutical-portfolio' target='_blank'>Incyte Drug Information Page</a> </li></ul>

105

NEAREST SITE: 341 miles
Cedars Sinai Medical Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04604158

Elly Mobile Application to Reduce Anxiety in People Living With Breast Cancer

IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients Scientific Title

Purpose

To study if the Elly iPhone application reduces anxiety, stress, loneliness, and social isolation.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who are receiving treatment or have received treatment within the past 6 months. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elly iPhone application</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Elly mobile application delivers daily audio recordings aimed at reducing anxiety, stress, loneliness, and social isolation.</li> <li class="seamTextUnorderedListItem">In this trial, the Elly mobile application is only available on iPhones.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04604158' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ellyhealth.com/' target='_blank'>Elly Health: Elly Mobile App</a> </li></ul>

106

NEAREST SITE: 341 miles
Beverly Hills Cancer Center
Beverly Hills,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04957290

Idronoxil with External Beam Radiotherapy for Advanced Breast Cancer

A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of idronoxil (Veyonda®), an experimental immunotherapy, with EBRT radiation.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Idronoxil (Veyonda®), as a rectal suppository, daily, for 2 weeks, followed by 1 week on/1 week off, ongoing</li> <li class="seamTextUnorderedListItem">EBRT radiation, over 5-10 days</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Idronoxil (Veyonda®) is an immunotherapy that prevents cancer cells from growing and activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Idronoxil (Veyonda®) has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">External Beam Radiotherapy (EBRT) is the most common type of radiation therapy used to treat breast cancer.</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/NCT04957290' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.noxopharm.com/site/our-science/about-veyonda#:~:text=It%20has%20been%20observed%20in,the%20development%20of%20septic%20shock.' target='_blank'>Noxopharm Drug Information Page: Idronoxil (Veyonda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.noxopharm.com/site/content/white-paper/' target='_blank'>Noxopharm White Paper: Idronoxil (Veyonda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy/external' target='_blank'>Breastcancer.org: External Beam Radiation Therapy (EBRT)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.5533' target='_blank'>Abstract: Idronoxil with External Beam Radiotherapy</a> </li></ul>

107

NEAREST SITE: 341 miles
Research Site
Beverly Hills,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05113251

Neoadjuvant Trastuzumab Deruxtecan ADC (Before Surgery) for HER2 Positive Stage I-III Breast Cancer

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant trastuzumab deruxtecan (Enhertu®), a type of targeted therapy called an antibody drug conjugate (ADC), alone or with chemotherapy and targeted therapy, compared to standard treatment, given before surgery.

Who is this for?

People with stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have not yet received treatment. You are eligible if you have inflammatory breast cancer (IBC). 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">Trastuzumab deruxtecan (Enhertu®), by IV</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol® or Onxol®), by IV</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin® or Herzuma®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> </ul> Group 3: Standard Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin® or Rubex®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Neosar® or Cytoxan®), by IV</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol® or Onxol®), by IV</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin® or Herzuma®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant treatment is treatment given before surgery to shrink your tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a type of immunotherapy 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">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody trastuzumab to deliver the chemotherapy DM1 directly to the 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">Trastuzumab (Herceptin® or Herzuma®) and pertuzumab (Perjeta®) are types of HER2-targeted therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol® or Onxol®), doxorubicin (Adriamycin® or Rubex®), and cyclophosphamide (Neosar® or Cytoxan®) are chemotherapy drugs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05113251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</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.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</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: Antibody Drug Conjugates (ADC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/neoadjuvant-therapy/' target='_blank'>Susan G. Komen: Neoadjuvant Therapy</a> </li></ul>

108

NEAREST SITE: 341 miles
Lawrence J. Ellison Institute for Transformative Medicine
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05252390

NUV-868 Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide 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 NUV-868, an experimental targeted therapy, alone or with olaparib (Lynparza®) or enzalutamide (Xtandi®) targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least 1 line of chemotherapy for advanced or metastatic disease. If you have a BRCA mutation, you must have received treatment with talazoparib (Talzenna®) or olaparib (Lynparza®). Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868 is an experimental targeted therapy called a BET inhibitor. Blocking BET may help slow or stop the growth of cancer cells.</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">Enzalutamide (Xtandi®) is a type of targeted therapy called an androgen receptor (AR) inhibitor. It is approved to treat advanced prostate cancer.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05252390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nuvationbio.com/pipeline/' target='_blank'>Nuvation Bio: NUV-868 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>MedlinePlus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

109

NEAREST SITE: 341 miles
Cancer Clinical Trials Office
Los Angeles,CA

VISITS: 8 visits

PHASE: NA

NCT ID: NCT05403736

Improving Heart Heath After Radiation for Stage I-IV Breast Cancer

IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial Scientific Title

Purpose

To hold cardio-oncology consultations during cancer treatment to improve heart health after radiation therapy.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer receiving or planning to receive radiation where the heart is in the treatment field. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cardio-oncology consultation, weekly for 6 weeks, then 2 follow-up visits within 5 months</li> <li class="seamTextUnorderedListItem">Wearable devices</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">Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan.</li> <li class="seamTextUnorderedListItem">Wearable devices, such as a FitBit, remote EKG, and remote blood pressure monitoring, will be used to monitor your health.</li> <li class="seamTextUnorderedListItem">Blood will be drawn 3 times for biomarker testing of heart injury, aging, inflammation and metabolism.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05403736' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/17409-radiation-heart-disease-overview' target='_blank'>Cleveland Clinic: Radiation Heart Disease</a> </li></ul>

110

NEAREST SITE: 342 miles
Research Site
Glendale,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04784715

Trastuzumab Deruxtecan With or Without Pertuzumab as First Line Treatment for HER2+ Advanced Breast Cancer

Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09) Scientific Title

Purpose

To compare the effects of giving trastuzumab deruxtecan (Enhertu®,T-DXd, DS-8201a), either alone or in combination with pertuzumab, with the standard of care, as a first line of treatment for HER2 positive breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received no prior chemotherapy or HER2-targeted therapy for metastatic disease. 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">Trastuzumab deruxtecan (Enhertu®), by IV</li> <li class="seamTextUnorderedListItem">Placebo, by IV</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> </ul> Group 3: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) or paclitaxel (Taxol®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by iV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtican (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. It is approved 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">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat early-stage and metastatic HER2 positive (HER2+) breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04784715' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/enhertu' target='_blank'>Breastcancer.org: Enhertu</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/perjeta' target='_blank'>Breastcancer.org: Perjeta</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin' target='_blank'>Breastcancer.org: Herceptin</a> </li></ul>

111

NEAREST SITE: 342 miles
California Research Institute
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05386108

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant, an experimental hormone therapy, alone or with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?

People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastasis) who have received at least 1 hormone therapy, up to 2 chemotherapies, and up to 2 CDK 4/6 inhibitors for metastatic disease. 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">Elacestrant, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®)</li> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</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">In this trial, HER2 low is defined as IHC 1+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05386108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</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://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

112

NEAREST SITE: 346 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05374512

Datopotamab Deruxtecan ADC for Metastatic Triple Negative Breast Cancer

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan, 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 not received chemotherapy or targeted therapy for advanced disease. You must not have received treatment with trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®). You must have at least 1 tumor that has not been treated with radiation. Full eligibility criteria

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What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan, by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), capecitabine (Xeloda®), paraplatin (Carboplatin®), or eribulin (Halaven®)</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.</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">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), capecitabine (Xeloda®), paraplatin (Carboplatin®), or eribulin (Halaven®) are chemotherapy drugs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05374512' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/february-10-2022/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Datopotamab Deruxtecan Shows Activity in Advanced Triple Negative Breast Cancer</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'>Metastastic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>