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(Last updated: January 11, 2022)

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

VISITS: 3 or 5 visits, over 5 years

PHASE: III

NCT ID: NCT03233191

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

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) Scientific Title

Purpose

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

Who is this for?

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

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

NEAREST SITE: 2 miles
Homebased Telemedicine
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04644315

Alectinib for Locally-Advanced or Metastatic ALK-Positive Breast Cancer

A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors Scientific Title

Purpose

To study the safety and anti-cancer activity of Alectinib, an ALK inhibitor.

Who is this for?

People with locally advanced (some stage III) or metastatic (stage IV) ALK-positive breast cancer that has not responded to other treatment options. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alectinib, by mouth, twice daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alectinib is an ALK inhibitor—a targeted therapy that blocks the activity of mutated ALK proteins.</li> <li class="seamTextUnorderedListItem">Alectinib is used to treat non-small cell lung cancer that has spread and is ALK positive.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04644315' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/alectinib' target='_blank'>Cancer.gov: Alectinib</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
University of California, San Francisco Medical Center
San Francisco,CA

VISITS: 1 visit every 4 weeks, ongoing

PHASE: II

NCT ID: NCT01494662

Neratinib for HER2-Positive Brain Metastases

A Phase II Trial of HKI-272 (Neratinib) for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases Scientific Title

Purpose

To determine how well neratinib works in treating breast cancer that has spread to the brain, as well as the effect that it has on cognitive functioning.

Who is this for?

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

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib by mouth daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain metastases are difficult to treat because many drugs are unable to cross the blood-brain barrier, which means they cannot enter the brain from the bloodstream. </li> <li class="seamTextUnorderedListItem">The experimental drug Neratinib (HKI-272) is a tyrosine kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It works by blocking the HER2 and EGFR receptors, both of which are involved in cancer cell growth. </li> <li class="seamTextUnorderedListItem">Neratinib is a much smaller molecule than Herceptin® (the drug widely used to treat HER2+ tumors), and it is able to cross the blood-brain barrier. </li> <li class="seamTextUnorderedListItem">The goal of this trial is to determine how well neratinib works in treating breast cancer that has spread to the brain, as well as the effect that it has on cognitive functioning.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01494662' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.sciencedaily.com/releases/2009/05/090528203821.htm' target='_blank'>Science Daily Article</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.curetoday.com/index.cfm/fuseaction/news.showNewsArticle/id/5/news_id/2357' target='_blank'>Cure Magazine Article</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/search.jsp?terms=neratinib' target='_blank'>BreastCancer.org: Neratinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://externalmediasite.partners.org/Mediasite/Play/dbc4bfbf0f6a46208443613881b188e41d' 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: Coincides with surgery

PHASE: NA

NCT ID: NCT01570998

Targeted Intraoperative Radiotherapy (TARGIT) Registry Trial

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

Purpose

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

Who is this for?

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

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

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

VISITS: After surgery, visits 5 days a week, 5-6 weeks

PHASE: III

NCT ID: NCT01901094

Lymph Node Dissection & Radiation or Radiation Alone for People Who Still Had Cancer Cells in Their Lymph Nodes After Neoadjuvant Therapy

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy Scientific Title

Purpose

To compare the anti-cancer activity of axillary lymph node dissection (surgery to remove your lymph nodes) followed by radiation therapy to radiation therapy alone.

Who is this for?

People with stage I, stage II, or stage III breast cancer who still had cancer cells in their lymph nodes after they received neoadjuvant 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">Surgery to identify sentinel lymph node(s)</li> <li class="seamTextUnorderedListItem">Axillary Lymph Node Dissection (ALND)</li> <li class="seamTextUnorderedListItem">Radiation therapy, 5 days a week, for 5-6 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to identify sentinel lymph node(s)</li> <li class="seamTextUnorderedListItem">Radiation therapy, 5 days a week, over 5-6 weeks</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">The surgery that removes lymph nodes from your underarm area is called an axillary lymph node dissection (ALND).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01901094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/surgery/lymph_node_removal/axillary_dissection' target='_blank'>Breastcancer.org: Axillary Lymph Node Dissection</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/surgery-for-breast-cancer/lymph-node-surgery-for-breast-cancer.html' target='_blank'>American Cancer Society: Lymph Node Surgery for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/issues/march-10-2019/long-term-study-finds-axillary-radiotherapy-safe-and-effective-after-positive-sentinel-node-biopsy/' target='_blank'>ASCO Post: Long-Term Study Finds Axillary Radiotherapy Safe and Effective After Positive Sentinel Node Biopsy</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT01969643

SGN-LIV1A for Women With Advanced HER2 Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose and anti-tumor activity of SGN-LIV1A--an experimental antibody-drug conjuate (ADC).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. 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></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.</li> <li class="seamTextUnorderedListItem">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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01969643' 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></ul>

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

VISITS: 1-2 visits over 3 weeks

PHASE: II

NCT ID: NCT02206984

Hormone Therapy Before Surgery for Women with Stage I-III Lobular Breast Cancer

A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer Scientific Title

Purpose

To look at which anti-estrogen treatment is best to use before surgery.

Who is this for?

Postmenopausal women with stage I, stage II, or stage III lobular breast cancer who had not yet had surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups and receive the following for 3 weeks before surgery: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily </li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), injected into a muscle (like a shot), on days 1 and 14</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Each woman in this study will receive one of the three anti-estrogen drugs: tamoxifen (Nolvadex®), anastrozole (Arimidex®), and fulvestrant (Faslodex®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02206984' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lobularbreastcancer.org' target='_blank'>Lobular Breast Cancer Alliance</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/diagnosis/rate_grade' target='_blank'>Breastcancer.org: Ki-67</a> </li></ul>

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

VISITS: Visits every 3 weeks for 3 months

PHASE: III

NCT ID: NCT02445391

Chemo After Neoaduvant Chemo and Surgery for Basal-Like Triple-Negative or ER-Low, HER2- Breast Cancer

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (EA1131) Scientific Title

Purpose

To see whether giving a chemotherapy after surgery reduces the risk of recurrence.

Who is this for?

People with triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who had neoadjuvant therapy that did not make their tumor disappear. Full eligibility criteria

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Participants will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) or Carboplatin (Paraplatin®) by IV, every 3 weeks</li> </ul> Group 2: No intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation</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">Most triple-negative breast cancers have basal-like qualities, meaning the cells resemble the basal cells that line the breast ducts. </li> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. Sometimes the tumor will disappear completely. In other instances, the tumor can be seen during surgery. </li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) and carboplatin (Paraplatin®) are platinum-based chemotherapies that laboratory studies suggest may be effective against basal-like triple-negative breast cancer. </li> <li class="seamTextUnorderedListItem">Participants will have their tumor specimens tested for basal-like qualities.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02445391' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.medscape.com/viewarticle/736911_4' target='_blank'>MedScape: Basal-like breast cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.ca/en/cancer-information/cancer-type/breast/breast-cancer/cancerous-tumours/triple-negative-breast-cancer/?region=on' target='_blank'>Canadian Cancer Society: Triple-negative and basal-like breast cancers</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02465060

NCI-MATCH: Using Genomic Test Results To Choose A Targeted Therapy For Metastatic Breast Cancer

A Basket study: Molecular Analysis for Therapy Choice (MATCH) Scientific Title

Purpose

To study the anti-cancer activity of receiving a targeting therapy that was chosen based on the results of your tumor's genomic testing.

Who is this for?

People with metastatic (stage IV) breast cancer whose cancer progressed during or after standard of care treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Your tumor sample will be tested for genetic mutations (genomic testing)</li> <li class="seamTextUnorderedListItem">You will be assigned to 1 of 24 treatment groups based on the results of your tumor's genomic test</li> <li class="seamTextUnorderedListItem">End-of-treatment biopsy and collection of blood samples for research purposes (optional)</li> <li class="seamTextUnorderedListItem">This process may be repeated if your disease progresses</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genomic testing looks at genetic mutations within your tumor.</li> <li class="seamTextUnorderedListItem">The drug you receive will be determined by the results of your tumor's genomic test. </li> <li class="seamTextUnorderedListItem">Your may receive one or more of the following drugs: Adavosertib, Afatinib, Binimetinib, Capivasertib, Copanlisib, Crizotinib, Dabrafenib, Dasatinib, Defactinib, Erdafitinib, FGFR Inhibitor AZD4547, Larotrectinib, Nivolumab, Osimertinib, Palbociclib (CDK inhibitor), Pertuzumab (anti-HER2), PI3K-beta Inhibitor GSK2636771, Sapanisertib, Sunitinib Malate, Taselisib, Trametinib, Trastuzumab emtansine/T-DM1 (Kadcyla®) (antibody-drug conjugate (ADC)), Vismodegib</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ABL, ALK, BRAF, CDK4, CDK6, CSF-1R, EGFR, EGFR T790M, FGFR, FLT3, HER2 (ERBB2), KIT, MET, MEK, mTOR, NTRK fusions, PD-1, PDGFR, PI3K, PTCH1, PTEN loss, RET, ROS1, SMO, TRK, VEGFR, WEE1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02465060' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match' target='_blank'>National Cancer Institute Study Website: NCI-Match</a> </li><li class='seamTextUnorderedListItem'><a href='https://ecog-acrin.org/nci-match-eay131' target='_blank'>ECOG-ACRIN Cancer Research Group: NCI-Match</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></ul>

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

VISITS: Online surveys

PHASE: NA

NCT ID: NCT02620852

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable, over 4 months

PHASE: NA

NCT ID: NCT02872025

Pembrolizumab Before Surgery for Women With High-Risk DCIS

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03053193

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable, up to 2 years

PHASE: II

NCT ID: NCT03094052

Diarrhea Prevention for People With HER2+ Breast Cancer Receiving Neratinib Alone or With Herceptin

An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early Stage HER2+ Breast Cancer Treated With Adjuvant Trastuzumab and Neratinib Followed by Neratinib Monotherapy, and Intensive Anti-diarrhea Prophylaxis Scientific Title

Purpose

To study whether taking anti-diarrhea medication can help prevent diarrhea in people being treated with neratinib (Nerlynx®) alone or in combination with trastuzumab (Herceptin®).

Who is this for?

People with stage II or stage III, HER2 positive (HER2+) breast cancer who have finished chemotherapy and radiation therapy and who are still receiving adjuvant trastuzumab (Herceptin®) or are within 1 year of finishing trastuzumab (Herceptin®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, as indicated by your doctor</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, up to 2 years</li> <li class="seamTextUnorderedListItem">Loperamide, by mouth, daily for 6 weeks, then as needed</li> <li class="seamTextUnorderedListItem">Crofelemer (Mytesi®), by mouth, daily for 6 weeks, then as needed</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two approved HER2-targeted drugs used in this trial are trastuzumab (Herceptin®) and neratinib (Nerlynx®)</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is known to cause diarrhea.</li> <li class="seamTextUnorderedListItem">Crofelemer (Mytesi®) is a medicine used to prevent diarrhea in people being treated for HIV/AIDS. </li> <li class="seamTextUnorderedListItem">Loperamide (Immodium) is an over-the-counter medication used to prevent and treat diarrhea.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03094052' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.fulyzaq.com/' target='_blank'>Drug Company Information Page: Crofelemer (Mytesi)</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/web-exclusives/fda-accepts-neratinib-nda-for-her2positive-breast-cancer' target='_blank'>OncLive: Neratinib</a> </li></ul>

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

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03095352

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Scientific Title

Purpose

To compare the safety and effects (good and bad) of giving immunotherapy along with chemotherapy versus giving chemotherapy alone to treat breast cancer that has spread to the chest wall.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has spread to the chest wall and cannot be removed by 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">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment </li> </ul> Group 2: Standard treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is the immunotherapy drug used in this study. It is a PDL-1 inhibitor approved to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is the chemotherapy used in this study.</li> <li class="seamTextUnorderedListItem">In this trial, researchers will test tumor biopsies and blood samples before and after treatment in order to learn more about how genes and the immune system affect how tumors respond to immunotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03095352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.TPS1113' target='_blank'>ASCO Abstract: Pembrolizumab and Carboplatin</a> </li></ul>

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

VISITS: Weekly visits for 3-6 months; then 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03199885

Paclitaxel, Trastuzumab, & Pertuzumab With or Without Atezolizumab For Metastatic HER2+ Breast Cancer

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab With Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer Scientific Title

Purpose

To compare the safety and effects of the combination of pertuzumab (Perjeta®), trastuzumab (Herceptin®), paclitaxel (Taxol®), and atezolizumab (Tecentriq®) with the combination of pertuzumab (Perjeta®), trastuzumab (Herceptin®), paclitaxel (Taxol®), and a placebo.

Who is this for?

People who are starting treatment for metastatic (stage IV) breast cancer or have had their breast cancer recur after 6 months of neoadjuvant or adjuvant HER2-targeted 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">Pertuzumab, (Perjeta®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3-6 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pertuzumab, (Perjeta®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3-6 months</li> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2 positive (HER2+) breast cancer. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03199885' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/perjeta' target='_blank'>Breastcancer.org: Perjeta® (Pertuzumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Targeted Therapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Taxol.aspx' target='_blank'>Chemocare: Taxol</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: NCT03250676

H3B-6545 for Postmenopausal Women with ER+, HER2- Breast Cancer

A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer Scientific Title

Purpose

To determine the best dose, safety, and effects (good and bad) of an experimental anti-estrogen drug called H3B-6545.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) breast cancer that is estrogen receptor positive and HER2 negative. Your cancer must have progressed on your most recent therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">H3B-6545, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">H3B-6545 is the 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/NCT03250676' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/77/13_Supplement/DDT01-04' target='_blank'>AACR Abstract: H3B-6545</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family CCC
San Francisco,CA

VISITS: 1-2 visits a month, ongoing

PHASE: I-II

NCT ID: NCT03280563

Immunotherapies, Targeted Therapies, and Anti-Estrogen Therapies for Advanced Hormone Positive, HER2 Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer) Scientific Title

Purpose

To evaluate the safety, effects (good and bad), and anti-cancer activity of several therapy combinations that include immunotherapies, targeted therapies, and anti-estrogen therapies.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (ER+, HER2-) breast cancer. Your cancer must have recurred or progressed on your most recent treatment. Full eligibility criteria

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You will be assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Entinostat, by mouth, once a week, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection or tamoxifen (Nolvadex®) or exemestane (Aromasin®) by mouth</li> </ul> Group 7 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> If your disease progresses while on treatment, you may be eligible to receive a new combination treatment. Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies may be required</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 checkpoint inhibitor. It is approved to treat locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Entinostat is an investigational type of targeted therapy called an HDAC inhibitor.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a new type of cancer drug that works by blocking the Akt protein</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin) is a monoclonal antibody that keeps tumors from growing by shrinking their supplying blood vessels. Avastin is used to treat HER2-negative metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat 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/NCT03280563' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biooncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech Drug Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/hormone-therapy/fulvestrant-faslodex' target='_blank'>Breast Cancer Now: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/entinostat' target='_blank'>NCI Drug Dictionary: Entinostat</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/avastin' target='_blank'>Breastcancer.org: Avastin</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03289962

Personalized Cancer Vaccine With or Without Atezolizumab for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using a personalized cancer vaccine (RO7198457) alone or with an immunotherapy drug (the PD-LI inhibitor atezolizumab).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Your cancer must have progressed after receiving standard of care therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The personalized cancer vaccine is called RO7198457. </li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) works by blocking the PD-L1 (programmed death-ligand 1) protein and is approved to treat certain types of cancer. Its use in breast cancer 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/NCT03289962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq-hcp.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=791183' target='_blank'>NCI Drug Dictionary: RO7198457</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03326102

Oral Paclitaxel in HER2- Recurrent and Metastatic Breast Cancer (OPERA)

A Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®, Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer (OPERA) Scientific Title

Purpose

To compare the safety and effects (good and bad) of paclitaxel taken by mouth with paclitaxel that is given through a vein (IV).

Who is this for?

People with HER2-negative recurrent or metastatic (stage IV) breast cancer that has been treated with up to three lines of therapy other than a taxane. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups in a 2:1 ratio (twice as many participants will be in Group 1 as compared to Group 2): Group 1: Paclitaxel by mouth <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DHP107 by mouth, once a week, 3 weeks on/1 week off</li> </ul> Group 2: Paclitaxel by IV <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on/1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The IV form of paclitaxel (Taxol®) is approved to treat metastatic breast cancer in the U.S.</li> <li class="seamTextUnorderedListItem">The oral form (DHP107) is approved to treat metastatic breast cancer in Korea. There it is sold as Liporaxel®.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03326102' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/paclitaxel' target='_blank'>Cancer Research UK: Paclitaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.1084' target='_blank'>Journal of Clinical Oncology: Oral paclitaxel in the treatment of metastatic breast cancer (MBC) patients</a> </li></ul>

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

VISITS: Visits every 1.5 months for 6 months, then ever 3 months thereafter

PHASE: II

NCT ID: NCT03344965

Olaparib for Metastatic Breast Cancer with an Inherited Genetic Mutation

A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients With Germline or Somatic Mutations in DNA Repair Genes (Olaparib Expanded) Scientific Title

Purpose

To investigate the safety and effect (good and bad) of olaparib (Lynparza®) in treating metastatic breast cancer that has a DNA repair gene mutation, such as BRCA1 or BRCA2.

Who is this for?

Women and men with metastatic (stage IV) breast cancer that has inherited mutations. You may not have progressed on more than two chemotherapy regimens in the metastatic setting Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily, ongoing </li> <li class="seamTextUnorderedListItem">Tumor measurements, every 1.5 months for 6 months, then every 3 months thereafter</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy known as a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">PARP helps repair DNA when it becomes damaged. Studies showed that the tumors in individuals who have inherited or acquired a mutation in the BRCA1 or BRCA2 genes are often sensitive to killing by PARP inhibitors.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat recurrent ovarian cancer. </li> <li class="seamTextUnorderedListItem">Patients with inherited BRCA1/2 mutations are NOT eligible for this study</li> <li class="seamTextUnorderedListItem">Mutations or deficiencies being studied: somatic BRCA1/2 mutation, ATM, ATR, BARD1, BRIP1 (FANCJ), CHEK2 , FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN, PALB2, RAD50, RAD51C, RAD51D, plus other HR-related genes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03344965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/risk/factors/genetics' target='_blank'>Breastcancer.org: Genetics</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></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
UCSF Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03454451

CPI-006 Alone or With CPI-444 or Keytruda in Advanced Triple Negative Breast Cancer

A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent, In Combination With CPI-444, And In Combination With Pembrolizumab In Adult Subjects With Advanced Cancers Scientific Title

Purpose

To test the safety and effects (good and bad) of CPI-006 when it is given alone or with CPI-444 or with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options. 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">CPI-006, by IV, once every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">CPI-444, by mouth, twice daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006 is an investigational immunotherapy that gets the immune system to after cancer cells by targeting CD73. </li> <li class="seamTextUnorderedListItem">CPI-444 is an investigational immunotherapy that targets the adenosine-A2A receptor (ADORA2A) on immune cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study 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/NCT03454451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.2505' target='_blank'>Journal of Clinical Oncology: CPI-006, an anti-CD73 antibody with immune modulating activity, in a phase 1 trial in advanced cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/adenosine-a2a-receptor-antagonist-cpi-444' target='_blank'>NCI Drug Dictionary: adenosine-A2A receptor antagonist CPI-444</a> </li></ul>

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

VISITS: 4 visits over 2 months

PHASE: I

NCT ID: NCT03517488

XmAb20717 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb20717 in Subjects With Selected Advanced Solid Tumors (DUET-2) Scientific Title

Purpose

To test the safety, effects (good and bad) and best dose of an experimental immunotherapy called XmAb20717.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb20717, by IV, once every 2 weeks, for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb20717 blocks two proteins on immune cells, PD-1 and CTLA4. </li> <li class="seamTextUnorderedListItem">Blocking these proteins helps your immune system see and 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/NCT03517488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793410' target='_blank'>NCI drug dictionary: XmAb20717</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/xencor-doses-first-patient-in-phase-1-study-of-xmab20717-dual-checkpoint-inhibitor-for-the-treatment-of-advanced-solid-tumors-300680374.html' target='_blank'>Xencor press release: XmAb20717</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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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 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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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) combined with OBI-821, by injection, 21 times over 2 years </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by injection, 21 times over 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) is the investigational immunotherapy used in this study. </li> <li class="seamTextUnorderedListItem">It is given along with the investigational drug OBI-821, which is designed to help stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03562637' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT03562637' target='_blank'>UCSF Trial Information Page: GLORIA</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/adagloxad-simolenin/' target='_blank'>Immuno-Oncology News: Adagloxad Simolenin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/saponin-based-immunoadjuvant-obi-821' target='_blank'>NCI Drug Dictionary: OBI-821</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/80/4_Supplement/OT1-08-03' target='_blank'>AACR Abstract: (OBI-822) and OBI-821</a> </li></ul>

NEAREST SITE: 3 miles
University of California at San Francisco ( Site 0004)
San Francisco,CA

VISITS: 3 visits per month, ongoing

PHASE: I

NCT ID: NCT03564691

MK-4830 With Pembrolizumab and Chemotherapy For Advanced Triple Negative Breast Cancer

A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and anti-cancer activity of MK-4830 (a targeted therapy), pembrolizumab (immunotherapy) and chemotherapy.

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 started treatment for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">MK-4830, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-4830 is a monoclonal antibody that targets the protein ILT4.</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">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/NCT03564691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncozine.com/esmo-2020-first-in-class-mk-4830-antibody-targeting-ilt4-shows-promising-preliminary-results/' target='_blank'>ESMO 2020: MK-4830 Antibody Targeting ILT4 Shows Promising Preliminary Results</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03742895

PARP Inhibitor Olaparib for Metastatic Breast Cancer That Tests Positive for a BRCA1/2 Tumor Mutation

A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of using the PARP inhibitor Olaparib (Lynparza®) in cancer with a BRCA1/2 tumor mutation.

Who is this for?

People with metastatic (stage IV) breast cancer that tests positive for a BRCA1 or BRCA2 tumor (not inherited) mutation who have already recieved an anthracycline and a taxane-based chemotherapy. You may not enroll in this trial if you have an inherited BRCA1/2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, ongoing</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">BRCA1/2 mutations can be inherited (also called germline) or in a tumor (also called somatic). </li> <li class="seamTextUnorderedListItem">This trial is only enrolling people with tumor BRCA1/2 mutations. </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">This trial is also enrolling people with other types of advanced cancer that is BRCA1/2 tumor mutation positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1/2 tumor mutation</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742895' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/results/metastatic-breast-cancer-results.html' target='_blank'>AstraZeneca Information Page: Lynparza® (Olaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mygenecounsel.com/my-tumor-carries-a-brca-mutation/' target='_blank'>My Gene Counsel: A BRCA Mutation Was Found in My Tumor. Does This Mean I’m a BRCA Carrier?</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></ul>

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

VISITS: 1 to 4 visits monthly, ongoing

PHASE: I

NCT ID: NCT03829436

TPST-1120 Alone or With a Systemic Therapy in Advanced Triple Negative Breast Cancer

A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of TPST-1120 when it is used alone or with another anti-cancer drug.

Who is this for?

People with triple negative advanced (some stage III) or metastatic (stage IV) 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">TPST-1120, by mouth, twice daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once a month</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, once every 3 weeks</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV, once a week</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120 is an investigational drug that targets a protein called PPARα. </li> <li class="seamTextUnorderedListItem">The other drugs it may be given with are nivolumab (Opdivo®), docetaxel (Taxotere®), and cetuximab (Erbitux®). </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a PD-1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxotere is a chemotherapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Erbitux is a targeted therapy that blocks EGFR. It is approved to treat head, neck and colorectal cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients 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/NCT03829436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/reading-room/asco/breast-cancer/79947' target='_blank'>Medpage Today: Cetuximab in Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.esmo.org/Oncology-News/Promising-Response-Rates-in-Patients-with-Metastatic-TNBC-Treated-with-Nivolumab-After-Induction-Treatment' target='_blank'>ESMO: Promising Response Rates in Patients with Metastatic TNBC Treated with Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Breast Cancer Now: Docetaxel (Taxotere)</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/79/13_Supplement/3606' target='_blank'>AACR Poster Session Abstract: TPST-1120 suppresses tumor growth and stimulates anti-tumor immunity</a> </li></ul>

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

VISITS: At least 1 visit per month for 6 months

PHASE: I

NCT ID: NCT03970382

Personalized Immunotherapy With or Without Opdivo for Metastatic Hormone Positive Breast Cancer

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To determine the safety and the effects (good or bad) of an experimental T-cell immunotherapy called neoTCR-P1 when it is given with or without nivolumab (Opdivo®).

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer that has been treated with at least one standard therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), once a month, for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1 makes a patient's T-cells target a neoepitope (neoE) that is found on their cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. 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/NCT03970382' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/798453' target='_blank'>NCI Drug Dictionary: gene-edited autologous neoantigen-targeted NeoTCR-P1 T cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</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
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 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
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04171700

PARP Inhibitor Rucaparib in Advanced Breast Cancer that is BRCA+ (Inherited or Tumor) or Tests Positive for Other Mutations

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes (LODESTAR) Scientific Title

Purpose

To look at the safety, effects (good and bad), and anti-tumor activity of the PARP inhibitor rucaparib (Rubraca®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been treated with at least one standard of care therapy but no more than two lines of chemotherapy; and who have inherited (or whose tumor tests positive for) one of the several mutations listed below. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®), by mouth, twice a day, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®) is a PARP inhibitor: it blocks poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is approved to treat women with advanced ovarian cancer whose tumors have a BCRA 1 or BRCA 2 mutation. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">People with an inherited BRCA 1 or BRCA 2 mutation and whose tumor is HER2 negative (HER2-) tumor are not eligible for this trial. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1 (tumor or inherited), BRCA2 (tumor or inherited), PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04171700' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rubraca.com/?utm_source=google&utm_medium=cpc&utm_term=rucaparib&utm_campaign=Branded_Alone_GS_EX&gclid=Cj0KCQiAsbrxBRDpARIsAAnnz_OQBEzA3MVbEPTW02l-js4vH6_2yBSOiLDwbWxO914whM6BmwDeWMsaAse7EALw_wcB' target='_blank'>Drug Company Information Page: Rubraca® (Rucaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/02/04/mbc-news-8/' target='_blank'>Metastatic Trial Talk: Get the Latest News on PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncologypro.esmo.org/oncology-in-practice/anti-cancer-agents-and-biological-therapy/parp-inhibition-and-dna-damage-response-ddr/parp-inhibitors/clinical-activity/breast-cancer/ongoing-developments' target='_blank'>ESMO Oncology: PARP Inhibitors in Breast Cancer (HRR Gene Mutations)</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: 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 positive and/or PR 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/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: 3 miles
University of California - San Francisco
San Francisco,CA

VISITS: 3 visits a month, ongoing

PHASE: II

NCT ID: NCT04225117

Targeted Therapy Enfortumab Vedotin in Advanced, HER2 Negative Breast Cancer

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) Scientific Title

Purpose

To study the antitumor activity and effects (good and bad) of the experimental targeted therapy enfortumab vedotin (AGS-22CE).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-) breast cancer who have received chemotherapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enfortumab vedotin (ASG-22CE), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enfortumab vedotin (ASG-22CE) is an antibody-drug conjugate. It combines an antibody that targets a specific protein on cancer cells (Nectin-4) with a chemotherapy that can kill them.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04225117' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-nectin-4-antibody-drug-conjugate-asg-22ce' target='_blank'>NCI Drug Dictionary: Enfortumab Vedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/monoclonal-antibodies' target='_blank'>Cancer Research UK: Monoclonal Antibodies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/pipeline/enfortumab-vedotin' target='_blank'>Seagen Drug Information Page: Enfortumab Vedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fmed.2019.00200/full' target='_blank'>Journal Article: Nectin-4 Expression Is an Independent Prognostic Biomarker and Associated With Better Survival in Triple-Negative Breast Cancer</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
California Pacific Medical Center-Pacific Campus
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: 3 miles
California Pacific Medical Center-Pacific Campus
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 at San Francisco
San Francisco,CA

VISITS: 1 visit per week, ongoing

PHASE: II

NCT ID: NCT04461600

Targeted Therapy AL101 for Advanced Triple Negative or ER-Low Breast Cancer that Tests Positive for Notch Activation

A Phase 2, Multi-center, Open-label, Single Arm Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer (TENACITY) Scientific Title

Purpose

To study the safety and anti-cancer activity of the experimental targeted therapy called AL101.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have had no more than three therapies for advanced or metastatic disease and whose tumor tests positive for a Notch pathway activation mutation. Your tumor will be tested for this mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AL101, by IV, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">AL101 is a type of experimental targeted therapy called a GSI (selective small molecule gamma secretase inhibitor).</li> <li class="seamTextUnorderedListItem">GSIs work by blocking Notch pathway activation.</li> <li class="seamTextUnorderedListItem">Notch activation will be determined by a Next Generation Sequencing (NGS) test as part of the study.</li> <li class="seamTextUnorderedListItem">Your doctor will be provided the full results of your NGS test.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Notch activating mutation/alterations</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04461600' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ayalapharma.com/pipeline/investigational-therapies-al101-and-al102' target='_blank'>Ayala Pharmaceuticals Drug Information Page: AL101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hindawi.com/journals/jo/2019/8707053/' target='_blank'>Hindawi Journal of Oncology: Notch Signaling Activation as a Hallmark for Triple-Negative Breast Cancer Subtype</a> </li></ul>

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

VISITS: Number of visits unavailable, ongoing

PHASE: I

NCT ID: NCT04521686

Experimental Targeted Therapy LY3410738 for Advanced Breast Cancer with a Certain Mutation

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 Mutations Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of the experimental targeted therapy LY3410738.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose tumor tests positive for an IDH1 R132 mutation and who have no standard treatment options available. Your tumor will be tested for this mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3410738, by mouth, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3410738 is an experimental type of targeted therapy called a IDH1 inhibitor.</li> <li class="seamTextUnorderedListItem">Target or mutation: IDH1 R132</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04521686' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.loxooncology.com/pipeline' target='_blank'>Loxo Oncology Drug Information Page: LY3410738</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: NCT04526106

Targeted Therapy RLY-4008 for Advanced Breast Cancer with a FGFR2 Mutation, Fusion, or Amplification

A First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors Scientific Title

Purpose

To study the best dose, safety, side effects, and ant-cancer activity of the experimental targeted therapy RLY-4008.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests positive for a FGFR2 mutation, fusion, or amplification. Full eligibility criteria

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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-4008 is an experimental FGFR2 inhibitor. Researchers think inhibiting (blocking) the FGFR pathway may stop or slow the growth of certain tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: FGFR2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04526106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://relaytx.com/pipeline/' target='_blank'>Relay Therapeutics Drug Information Page: RLY-4008</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6071019/' target='_blank'>Journal Article: Current Status of Fibroblast Growth Factor Receptor-Targeted Therapies in Breast Cancer</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 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
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
University of California San Francisco
San Francisco,CA

VISITS: 1 visit

PHASE: NA

NCT ID: NCT04876378

Imaging to See How Aromatase Inhibitors Affects Joint Health in Stage I-III Breast Cancer

Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand Scientific Title

Purpose

To study how aromatase inhibitors (anti-estrogen therapy) affect hand and knee joints.

Who is this for?

People, 70 or younger, diagnosed with stage I, stage II, or stage III hormone-positive (ER+ and/or PR+) breast cancer who have been taking an aromatase inhibitor for at least one year. You may also enroll in this trial if you are postmenopausal and have never been diagnosed with breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, one time</li> <li class="seamTextUnorderedListItem">MRI, lasting about 1 hour, one time</li> <li class="seamTextUnorderedListItem">HR-pQCT (High-Resolution Peripheral Quantitative Computed Tomography), lasting about one hour, one time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of anti-estrogen therapy commonly used in people with hormone-positive breast cancer.</li> <li class="seamTextUnorderedListItem">The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Joint pain is a commonly reported side effect of taking an aromatase inhibitor.</li> <li class="seamTextUnorderedListItem">This trial will use two different imaging techniques to study knee and hand joints.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04876378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/aromatase_inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li></ul>

NEAREST SITE: 4 miles
University of California, San Francisco
San Francisco,CA

VISITS: 1 visit

PHASE: III

NCT ID: NCT04410133

Using PET Scan to Detect Recurrent Brain Metastases After Radiation

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy Scientific Title

Purpose

To determine whether a radiotracer (18F-Fluciclovine) can improve early detection of recurrent brain metastases by PET scan imaging.

Who is this for?

People with metastatic (stage IV) breast cancer whose cancer had spread to their brain (brain metastases) and whose brain metastases were previously treated with radiation therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">18F-Fluciclovine, by IV</li> <li class="seamTextUnorderedListItem">PET scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET scan (positron emission tomography) is an imaging test that allows your doctor to check for cancer in your body. </li> <li class="seamTextUnorderedListItem">PET scans use a special dye containing radioactive tracers that is injected into a vein.</li> <li class="seamTextUnorderedListItem">18-Fluciclovin is a radiotracer given by IV that is used to see cancer on a PET scan.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04410133' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></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: 8 miles
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: Daily visits for 5 or 6.5 weeks

PHASE: NA

NCT ID: NCT01872975

Additional Radiation for Women with Stage I-III Breast Cancer Who Received Chemotherapy before Breast Surgery

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant... Scientific Title

Purpose

To see if additional radiation after surgery reduces the risk of recurrence in women whose lymph node status changed from positive to negative after neoadjuvant chemotherapy.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who received neoadjuvant (before surgery) chemotherapy. Full eligibility criteria

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You will be assigned to 1 of 4 groups: Group 1: Post-Lumpectomy Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole Breast Radiation, 5 days a week, for 5 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy boost to the lumpectomy cavity, 5 days a week, for 1.5 weeks </li> </ul> Group 2: Post-Mastectomy Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation</li> </ul> Group 3: Post-Lumpectomy Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole Breast Radiation, 5 days a week, for 5 weeks</li> <li class="seamTextUnorderedListItem">Regional nodal radiation therapy</li> <li class="seamTextUnorderedListItem">Radiation therapy boost to the lumpectomy cavity, 5 days a week, for 1.5 weeks </li> </ul> Group 4: Post-Mastectomy Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regional nodal and chest wall radiation therapy, 5 days a week, for 5 weeks</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 Quality of Life questionnaires, over 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy given before surgery (neoadjuvant treatment) can kill cancer cells in the lymph nodes. This means a woman who is initially node positive may be node negative at the time of surgery.</li> <li class="seamTextUnorderedListItem">The standard of care for women with early-stage breast cancer who have a lumpectomy is whole-breast radiation.</li> <li class="seamTextUnorderedListItem">Women who have a mastectomy typically do not receive radiation.</li> <li class="seamTextUnorderedListItem">Giving radiation to the lymph nodes following a lumpectomy and giving radiation to the chest wall and lymph nodes following a mastectomy may reduce the 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/NCT01872975' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 8 miles
Epic Care
Emeryville,CA

VISITS: Approximately 5 visits

PHASE: NA

NCT ID: NCT01992250

Cryoablation (Freezing) Instead of Surgery for Women Age 50+ With Small Tumors

Freezing Alone Instead of Resection and Radiotherapy Of Small Breast Tumors: A Study of Cryoablation in the Management of Prognostically Favorable Early Stage Breast Cancer in Elderly Women (FROST Trial) Scientific Title

Purpose

To compare the effects (good and bad) of using cryoablation instead of surgery on small tumors.

Who is this for?

Women, age 50 and older, with stage I hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose tumor is 1.5 cm or smaller. Full eligibility criteria

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You will be assigned to 1 of 2 groups depending on your age: Group 1: Age 50 to 69 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cryoablation of your tumor</li> <li class="seamTextUnorderedListItem">Standard of care radiation therapy</li> <li class="seamTextUnorderedListItem">Your doctor's choice of hormone therapy, for 5 years</li> </ul> Group 2: Age 70 or Older <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cryoablation of your tumor</li> <li class="seamTextUnorderedListItem">Your doctor's choice of hormone therapy, for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cryoablation uses extreme cold to destroy cancer cells.</li> <li class="seamTextUnorderedListItem">The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures to freeze and kill the cancer cells. </li> <li class="seamTextUnorderedListItem">The procedure does not leave significant scarring.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01992250' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/annual-report/annual-report-2016/breast-cancer-treatment.html' target='_blank'>MD Anderson Cancer Center: Treatment puts the Freeze on Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/News/59564' target='_blank'>ASCO: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/cancer-topics/breast-cancer/cryosurgery-the-future-of-breast-cancer-treatment/' target='_blank'>Cancer Therapy Advisor: Cryosurgery, The Future of Breast Cancer Treatment?</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03488693

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 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
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: 9 miles
Alta Bates Summit Medical Center - Summit Campus
Oakland,CA

VISITS: Coincides with surgery

PHASE: III

NCT ID: NCT03927027

Preventing Lymphedema in Women Having Breast Surgery and a Lymph Node Dissection

ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping Scientific Title

Purpose

To see if using a surgical technique called Axillary Reverse Mapping during surgery to remove lymph nodes from your underarm area (axillary lymph node dissection) prevents lymphedema.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who have not yet had surgery. 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">Isosulfan Blue, by injection, during surgery</li> <li class="seamTextUnorderedListItem">Axillary Lymph Node Dissection (ALND)</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Isosulfan Blue, by injection, during surgery</li> <li class="seamTextUnorderedListItem">Axillary Lymph Node Dissection (ALND)</li> <li class="seamTextUnorderedListItem">Axillary Reverse Mapping (ARM), during ALND</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lymphedema is abnormal swelling in the arm, hand, breast, or torso that may develop as a side effect of some breast cancer surgeries. </li> <li class="seamTextUnorderedListItem">Lymphedema happens when there is a blockage in your lymphatic system (a part of your immune system) that stops the lymph fluid from draining well. The fluid buildup causes the abnormal swelling. </li> <li class="seamTextUnorderedListItem">The surgery that removes lymph nodes from your underarm area is called an axillary lymph node dissection (ALND). This surgery may cause a blockage in your lymphatic system.</li> <li class="seamTextUnorderedListItem">During your ALND, a blue dye will be used to see your lymph nodes and the lymphatic channels that drain your arm. </li> <li class="seamTextUnorderedListItem">Axillary Reverse Mapping (ARM) is when your surgeon tries to avoid disrupting the lymph nodes and lymphatic channels that drain your arm. This may prevent you from developing lymphedema.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03927027' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/lymphedema/symptoms-causes/syc-20374682' target='_blank'>Mayo Clinic: Lymphedema</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/side-effects/lymphedema/lymphedema-pdq' target='_blank'>NCI: Lymphedema (PDQ®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/uploadedFiles/_Komen/Content/About_Breast_Cancer/Tools_and_Resources/Fact_Sheets_and_Breast_Self_Awareness_Cards/AxillaryLymphNodes.pdf' target='_blank'>Susan G. Komen: Axillary Lymph Nodes</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ons.org/node/1531?display=pepnavigator&sort_by=created&items_per_page=50' target='_blank'>Oncology Nursing Society: Axillary Reverse Mapping (ARM)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breast360.org/topic/2017/01/01/axillary-reverse-mapping/' target='_blank'>Breast360.org: Axillary Reverse Mapping</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04109066

Nivolumab Before and After Surgery For Stage II-III ER+, HER2- Breast Cancer

A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of using nivolumab (Opdivo®) before and after surgery in combination with standard of care treatment.

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental Before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy (paclitaxel/Taxol® followed by an anthracycline and cyclophosphamide/Cytoxan®)</li> </ul> After surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV</li> <li class="seamTextUnorderedListItem">Hormone therapy (physician's choice)</li> </ul> Group 2: Standard care Before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy (paclitaxel/Taxol® followed by an anthracycline and cyclophosphamide/Cytoxan®)</li> </ul> After surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV</li> <li class="seamTextUnorderedListItem">Hormone therapy (physician's choice)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">It is approved to treat certain other types of cancer. </li> <li class="seamTextUnorderedListItem">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/NCT04109066' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Nivolumab.aspx' target='_blank'>Chemocare: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.youtube.com/watch?reload=9&cid=eb_govdel&v=jDdL2bMQXfE' target='_blank'>NCI: Immunotherapy: How the Immune System Fights Cancer</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: 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 Patients 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 giving people with HER2+ breast cancer a beta-blocker can help prevent heart problems caused by cancer treatments.

Who is this for?

People with HER2 positive metastatic (stage IV) breast cancer who are starting or continuing a trastuzumab-based anit-HER2 therapy. 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>
The beta-blocker being used in this study is carvedilol. It is used to treat heart failure and high blood pressure.
<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: 25 miles
John Muir Health Clinical Research Center
Concord,CA

VISITS: 2-4 visits per month, for 5 months

PHASE: III

NCT ID: NCT03498716

Atezolizumab with Chemotherapy After Surgery for Stage II-III Triple-Negative Breast Cancer

A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer Scientific Title

Purpose

To compare the safety and effects (good and bad) of using an immunotherapy drug along with chemotherapy to chemotherapy alone.

Who is this for?

People, with stage II or stage III triple negative (ER-, PR- and HER2-) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Chemotherapy with Atezolizumab <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">followed by Tecentriq and dose-dense chemotherapy (physician's choice), by IV, every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Sargramostim or filgrastim</li> </ul> Group 2: Chemotherapy alone <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Followed by dose-dense chemotherapy (physician's choice), every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Sargramostim or filgrastim</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tatezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It gets the immune system to attack cancer cells by blocking a protein called PD-L1 (programmed death-ligand 1).</li> <li class="seamTextUnorderedListItem">Tatezolizumab is used to treat some triple negative (ER-, PR-, HER2-) breast cancers and some lung and bladder cancers.</li> <li class="seamTextUnorderedListItem">Your first chemotherapy will be paclitaxel (Taxol). It will be followed by dose-dense chemotherapy.</li> <li class="seamTextUnorderedListItem">Your doctor will decide if you receive doxorubicin (Adriamycin®) or epirubicin (Ellence®) and cyclophosphamide (Cytoxan®).</li> <li class="seamTextUnorderedListItem">You will also receive GM-CSF (sargramostim) or G-CSF (filgrastim) to prevent neutropenia--a low white blood cell count that increases your risk for infection.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03498716' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/media/product-information/tecentriq' target='_blank'>Genentech: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/symptoms/neutropenia/basics/definition/sym-20050854' target='_blank'>Mayo Clinic: Neutropenia</a> </li></ul>

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01034033

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 27 miles
Stanford University Hospitals and Clinics
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02401347

Talazoparib for Advanced HER2 Negative Breast Cancer with Certain Mutations

A Phase II Clinical Trial of BMN 673 in BRCA1 and BRCA2 Wild-Type Patients With (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency as Assessed by the HRD Assay, and (ii) Advanced HER2-Negative Breast Cancer With Either a Germline or Somatic Mutation in... Scientific Title

Purpose

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

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is HER2 negative (HER2-) and who have received at least one prior chemotherapy for metastatic disease. Your tumor must test positive for or express one of several markers. (See below for a list of targets and mutations.) You cannot enroll in this trial if you have an inherited BRCA 1 or BRCA 2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor that is approved to treat people with advanced or metastatic HER2 negative (HER2-) breast cancer and an inherited BRCA 1 or BRCA 2 mutation. </li> <li class="seamTextUnorderedListItem">You cannot enroll in this trial If you have an inherited BRCA 1 or BRCA 2 mutation.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Homologous Recombination Deficiency, PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, Rad51c, Rad51d, MRE11, ATR, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, plus other HR-related genes at the discretion of the primary investigators.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02401347' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com' target='_blank'>Pfizer Oncology Information Page: Talazoparib</a> </li></ul>

NEAREST SITE: 27 miles
Exelixis Clinical Site #21
Stanford,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03170960

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To assess the safety, best dose, and effects (good and bad) of cabozantinib (Cabometyx®) when it is used alone or with atezolizumab (Tecentriq®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has already been treated with at least one line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is 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/NCT03170960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>Medlineplus: Cabozantinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.1026' target='_blank'>ASCOPubs.org: A phase II study of cabozantinib alone or in combination with trastuzumab in patients with breast cancer brain metastases</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: Atezolizumab Approved for Some Patients with TNBC</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Cancer Institute
Stanford,CA

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03424005

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) Scientific Title

Purpose

To study the safety and effects (good and bad) of 7 different immunotherapy-based treatment combinations in people with triple negative (ER-/PR-/HER2-) breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (2 weeks on, 1 week off), ongoing </li> </ul> Group 7 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Physician's choice chemotherapy (gemcitabine/Gemzar® plus carboplatin/Paraplatin®, or eribulin/Halaven®), by IV, weekly (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq is approved to treat certain types of urinary, bladder and lung cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®).</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03424005' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Komen: Emerging Areas in Metastatic Breast Cancer Treatment</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.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</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 Cancer Institute (SCI)
Stanford,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04802759

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

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

Purpose

To study the anti-cancer activity and safety of giving the experimental anti-estrogen therapy giredestrant alone or with a CDK 4/6 inhibitor, an AKT inhibitor, a P13K inhibitor, or chemotherapy.

Who is this for?

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

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

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02926911

A Study Comparing Active Surveillance to Treatment for Low-Risk DCIS

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial Scientific Title

Purpose

To compare active surveillance--a mammogram every six months and optional anti-estrogen therapy--to the standard of care for treating DCIS.

Who is this for?

Women with hormone receptor positive (ER+ and/or PR+) DCIS who have not yet started treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and undergo the following: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery with or without radiation</li> <li class="seamTextUnorderedListItem">followed by mammogram, every 12 months for 5 years</li> <li class="seamTextUnorderedListItem">Optional endocrine therapy for 5 years</li> </ul> Group 2: Active Monitoring <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram, every 6 months for 5 years</li> <li class="seamTextUnorderedListItem">Optional endocrine therapy for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Not all DCIS will become invasive breast cancer. This means that some women being treated for DCIS are getting more treatment than is necessary. </li> <li class="seamTextUnorderedListItem">The standard of care is surgery, which may be followed by radiation and/or anti-estrogen treatment.</li> <li class="seamTextUnorderedListItem">For more information, email: thomas.lynch2@duke.edu</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02926911' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://dcisoptions.org/' target='_blank'>COMET study website</a> </li><li class='seamTextUnorderedListItem'><a href='https://am.asco.org/when-less-more-breast-cancer-treatment' target='_blank'>ASCO: When 'Less is More' in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pcori.org/research-results/2016/comparing-treatment-options-women-low-risk-ductal-carcinoma-situ-dcis-comet' target='_blank'>PCORI: Study information</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> <li class="seamTextUnorderedListItem">Targets or mutations: EGFR, BRAF, ERBB2 (HER2), and ALK</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 for Advanced Breast Cancer with a 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. You must have no other standard treatment options available and have previously received 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">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/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 Medical Center
Palo Alto,CA

VISITS: 4 visits every 6 weeks for 2 years

PHASE: II

NCT ID: NCT03567720

Tavo & Pembrolizumab (Immunotherapy) in Advanced Triple Negative Tumors

A Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Intravenous Pembrolizumab Therapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study tumor response to and the effects (good and bad) of using Tavo-EP and pembrolizumab (Keytruda®) together to treat advanced breast cancer.

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 receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tavo-EP (tavokinogene telseplasmid, pIL-12), by electroporation, 3 times every 6 weeks, for 2 years</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of cancers, and its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tumor infiltrating lymphocytes (TILs) are immune cells that have moved from the blood into a tumor cell. </li> <li class="seamTextUnorderedListItem">Studies have found that tumors with fewer TILs do not respond as well to immunotherapy.</li> <li class="seamTextUnorderedListItem">Tavo-EP (Tavoâ„¢) activates the immune system in a way that brings more TILs into the tumors. It is administered through electroporation, an electric current that makes it possible to put a drug or DNA into a cell. </li> <li class="seamTextUnorderedListItem">Researchers think using Tavo with Keytruda will make tumors more likely to respond to Keytruda.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03567720' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.oncosec.com/press-releases/detail/1942/oncosec-provides-highlights-from-research-reception-at-aacr' target='_blank'>OncoSec: Press Release (Tavo-EP)</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncosec.com/wp-content/uploads/2018/06/SITC-2017-Poster-Handout.pdf' target='_blank'>OncoSec: Poster Summary (Tavo-EP)</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03621982

ADCT-301 in Advanced Triple Negative Breast Cancer

A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) in Patients With Selected Advanced Solid Tumors Scientific Title

Purpose

To compare the safety and effects (good and bad) of ADCT-301, a targeted therapy that combines the monoclonal antibody HuMax-TAC with a new type of chemotherapy called PBD.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has not responded to other treatment options. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301 is a new type of targeted therapy that combines the monoclonal antibody HuMax-TAC with a new type of chemotherapy called PBD. </li> <li class="seamTextUnorderedListItem">The monoclonal antibody brings the chemotherapy directly to the cancer cells. </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/NCT03621982' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/editorial/adct-301-a-novel-antibody-drug-conjugate-against-lymphomas-moves-into-phase-i-clinical-trial/' target='_blank'>ADC Review: ADCT-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/2019/02/05/phase-1b-trial-of-adct-301-in-advanced-solid-tumors-dosed-first-patient/' target='_blank'>Immuno-Oncology News: ADCT-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Cancer Center ( Site 0072)
Palo Alto,CA

VISITS: Weekly visits for 1 month, then 1 visit every 3 weeks for 1 year

PHASE: III

NCT ID: NCT03725059

Chemotherapy & Endocrine Therapy With or Without Pembrolizumab in Stage I-III ER Positive, HER2 Negative Breast Cancer

A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756) Scientific Title

Purpose

To compare the anti-cancer activity of giving the immunotherapy pembrolizumab (Keytruda®) before and after surgery in combination with the standard of care chemotherapy and hormone therapy to just the standard of care chemotherapy and hormone therapy.

Who is this for?

People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Pembrolizumab plus standard of care Before surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel, by IV, weekly, for 1 month followed by</li> <li class="seamTextUnorderedListItem">Doxorubicin or epirubicin and cyclophosphamide, by IV, every 3 weeks, for 5 months</li> </ul> After surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks, for 7 months</li> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, daily, for 10 years</li> </ul> Group 2: Placebo plus standard of care Before surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel, by IV, weekly, for 1 month followed by</li> <li class="seamTextUnorderedListItem">Doxorubicin or epirubicin and cyclophosphamide, by IV, every 3 weeks, for 5 months</li> </ul> After surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, for 7 months</li> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, daily, for 10 years</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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03725059' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://merckoncologyclinicaltrials.com/en-us/patient/trial/NCT03725059' target='_blank'>Merck Oncology Study Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/gastrointestinal-cancers/cervical-cancer-pembrolizumab-fda-approval-treatment/article/773440/' target='_blank'>Cancer Therapy Advisor: Pembrolizumab FDA-Approved for the Treatment of Advanced Cervical Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm' target='_blank'>FDA: FDA approves first cancer treatment for any solid tumor with a specific genetic feature</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/hematology-oncology/breast-cancer/news/online/%7Bf4b314b6-7cb8-470f-ae44-0cddfe7762e7%7D/addition-of-pembrolizumab-to-chemotherapy-demonstrates-promise-in-triple-negative-breast-cancer' target='_blank'>HemOnc Today: Addition of pembrolizumab to chemotherapy demonstrates promise in triple-negative breast cancer</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University School of Medicine
Palo Alto,CA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I

NCT ID: NCT03821233

ZW49 in Patients With Advanced HER2-Positive Breast Cancer

A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers Scientific Title

Purpose

To evaluate the safety, effects (good and bad), and best dose of a new targeted therapy called ZW49.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZW49, by IV, every 2 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZW49 uses an antibody that can attach to HER2 proteins to deliver chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of HER2 positive tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03821233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zymeworks.com/our-pipeline/zw49' target='_blank'>Drug Company Study Information: ZW49</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/13_Supplement/3914' target='_blank'>AACR Journal Abstract: ZW49, A HER2-Targeted Biparatopic Antibody-Drug Conjugate for the Treatment of HER2-expressing Cancers</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Stanford,CA

VISITS: Daily visits for 5 days, followed by surgery

PHASE: NA

NCT ID: NCT03909282

Radiation Therapy Before Surgery For DCIS

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04106492

Experimental Therapy SQ3370 for Advanced Breast Cancer

A Multicenter Phase 1, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, dose, side effects and anti-cancer activity of the experimental therapy SQ3370.

Who is this for?

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

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SQL70, by injection into your tumor</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SQP33, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receiving SQ3370 is a 2-step process because it is made of two different therapies that are given separately.</li> <li class="seamTextUnorderedListItem">First you receive therapy SQL70 by injection directly into the area near your tumor. Then you receive therapy SQP33 by IV.</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/NCT04106492' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.e15525' target='_blank'>ASCO Abstract: Effect of Local Activation via SQ3370 on the Safety of Chemotherapy with Concomitant Anti-Tumor Immune Response</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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What's being studied?
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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 University
Stanford,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04504331

Infigratinib and Tamoxifen for Advanced, HR+, HER2- Breast Cancer with a FGFR Alteration

A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer Scientific Title

Purpose

To study the best dose, side effects, and anti-cancer activity of infigratinib when it is given in combination with the anti-estrogen therapy tamoxifen.

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. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Infigratinib, by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex ®) is an anti-estrogen therapy commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Infigratinib is an experimental kinase inhibitor, a type of targeted therapy, that is designed to block the FGFR (fibroblast growth factor receptor) protein.</li> <li class="seamTextUnorderedListItem">Research suggests that targeting FGFR may slow or stop cancer cell growth.</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/NCT04504331' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.qedtx.com/discover-infigratinib/' target='_blank'>QED Therapeutics Drug Information Page: Infigratinib</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'>MGH Cancer Center: Breast Cancer, FGFR</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedirect.com/science/article/abs/pii/S0960977617306094' target='_blank'>Journal Article: Targeting FGFR Pathway in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03251378

Targeted Therapy Fruquintinib for Metastatic HER2 Negative Breast Cancer

A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of the experimental targeted therapy fruquintinib.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have not already received a VEGFR inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fruquintinib, by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fruquintinib is a tyrosine kinase inhibitor, a type of targeted therapy, that is designed to block the VEGFR (vascular endothelial growth factor receptor) protein.</li> <li class="seamTextUnorderedListItem">Tumors use VEGFR to grow new blood vessels and research suggests VEGFR inhibitors may slow or stop cancer cell growth. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03251378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vicc.org/clinical-trials/protocol-viccgip1965' target='_blank'>Vanderbilt-Ingram Cancer Center Study Page</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><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/VEGF_receptor' target='_blank'>Wikipedia: VEGF Receptor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/drug-class/vegf-vegfr-inhibitors.html' target='_blank'>Drugs.com: What are VEGF/VEGFR inhibitors?</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, for 2 years

PHASE: I-II

NCT ID: NCT03761914

Immunotherapy Galinpepimut-S and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers Scientific Title

Purpose

To assess the safety, effects (good and bad) and best dose of the immunotherapy galinpepimut-S when it is used along with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options. Full eligibility criteria

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You will be given the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GM-CSF, by injection, before Galinpepimut-S</li> <li class="seamTextUnorderedListItem">Galinpepimut-S, by injection, every 3 weeks, for up to 2 years</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Galinpepimut-S is a vaccine that targets the protein WT1. </li> <li class="seamTextUnorderedListItem">Higher than normal amounts of this protein are found on the surface of breast and certain other 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 cancer. 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/NCT03761914' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sellaslifesciences.com/galinpepimut-s-gps-therapy/' target='_blank'>Trial Sponsor Sellas Lifescience: Galinpepimut-S Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/galinpepimut-s/' target='_blank'>Immuno-Oncology News: Galinpepimut-S</a> </li><li class='seamTextUnorderedListItem'><a href='https://pharmaphorum.com/views-and-analysis/asco-2017-breast-cancer-keytruda/' target='_blank'>Pharmaphorum: ASCO 2017: Breast cancer next target for Keytruda</a> </li></ul>

NEAREST SITE: 53 miles
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03893955

ABBV-927 and ABBV-368 for Advanced Triple Negative Breast Cancer

A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of using two experimental immunotherapies, ABBV-927 and ABBV-368, together.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not been treated with an immunotherapy and that did not respond to at least one systemic therapy that included a taxane. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-927, by IV</li> <li class="seamTextUnorderedListItem">ABBV-368, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-927 is an immunotherapy that gets the immune system to go after cancer cells by targeting a protein called CD40. </li> <li class="seamTextUnorderedListItem">ABBV-368 is an immunotherapy that targets OX40, which is found on certain T cells. </li> <li class="seamTextUnorderedListItem">This study is also recruiting 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/NCT03893955' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-abbv-927' target='_blank'>NCI Drug Dictionary: ABBV-927</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-368.html' target='_blank'>Drug company information page: ABBV-368</a> </li></ul>

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04494425

Trastuzumab Deruxtecan or Chemotherapy for Metastatic HR+, HER2-Low Breast Cancer

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06) Scientific Title

Purpose

To compare the anti-cancer activity, safety, and side effects of giving trastuzumab deruxtecan (Enhertu®) to giving chemotherapy.

Who is this for?

People with metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2-Low breast cancer who have already received at least one anti-hormone therapy 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">Trastuzumab deruxtecan (Enhertu®), by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your doctor's choice of chemotherapy: capecitabine (Xeloda®), paclitaxel (Taxol®), or nab-paclitaxel (Abraxane®) ongoing</li></ul>
<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">The chemotherapies capecitabine (Xeloda®), paclitaxel (Taxol®), and nab-paclitaxel (Abraxane®) are all commonly used to treat 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/NCT04494425' target='_blank'>ClinicalTrials.gov</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> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertu.com/en/gastric/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020&utm_content=branded+general_exact&utm_term=trastuzumab+deruxtecan&gclid=cj0kcqias5ecbhcbarisaehk4r7igokn76-yzybu0ziqrknxg5sw-w0t3uyeq-25nhutdetkzoiiwuua' target='_blank'>Daiichi Sankyo Company Drug Information Page: Enhertu® (Fam-Trastuzumab Deruxtican-nxki)</a> </li></ul>

NEAREST SITE: 61 miles
Stockton Hematology Oncology Medical Group
Stockton,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04752332

CDK 4/6 Inhibitor Abemaciclib for High-Risk, Early-Stage HR+, HER2+ Breast Cancer

eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy Scientific Title

Purpose

To study the anti-cancer activity and side effects of giving the targeted therapy abemaciclib (Verzenio®) with anti-hormone therapy to giving anti-hormone therapy alone after surgery.

Who is this for?

People with high-risk, early-stage hormone-positive (ER+ and/or PR+), HER2-positive (HER2+) breast cancer. See below for this trial's definition of high-risk. 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">Abemaciclib (Verzenio®), by mouth, daily, for up to 10 years</li> <li class="seamTextUnorderedListItem">Your doctor's choice of anti-hormone therapy, daily, for up to 10 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for abemaciclib (Verzenio®), by mouth, daily, for up to 10 years</li> <li class="seamTextUnorderedListItem">Your doctor's choice of anti-hormone therapy, by mouth, daily, for up to 10 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial defines high-risk as having some tumor remaining (residual disease) after receiving treatment before surgery, or four or more positive lymph nodes, or having at least one positive lymph node and your tumor is at least 5 cm or grade 3. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04752332' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/november-10-2019/abemaciclib-benefits-patients-with-her2-positive-breast-cancer-in-monarcher-trial/' target='_blank'>The ASCO Post: Abemaciclib Benefits Patients With HER2-Positive Breast Cancer in monarcHER Trial</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>

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

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT02849496

Olaparib Alone or With Atezolizumab for People With Advanced HER2 Negative Breast Cancer & an Inherited or Tumor BRCA1/2 Mutation

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To compare the anti-cancer activity of the targeted therapy olaparib (Lynparza®) when it is given alone to when it is given in combination with the immunotherapy atezolizumab (Tecentriq®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer who have an inherited BRCA 1 or BRCA 2 mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <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">Olaparib (Lynparza®) is approved to treat HER2 negative (HER2-) metastatic breast cancer in women with a BRCA 1/2 genetic mutation.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-LI inhibitor. It works by getting the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death ligand-1). </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is approved for use in advanced triple negative breast cancer. 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/NCT02849496' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com' target='_blank'>AstraZeneca Drug Information Page: Lynparza® (Olaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Drug Information Page: Tecentriq® (Atezolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

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

VISITS: Number of visits varies, ongoing

PHASE: II

NCT ID: NCT03606967

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

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

Purpose

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

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1: Vaccine <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized SLP Vaccine and Hiltonol® (poly-ICLC), 7 times over 2.5 months</li> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li> </ul> Group 2: No Vaccine <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of vaccine used in this trial is called a personalized synthetic long peptide (SLP) vaccine. It may help your immune system see and fight cancer cells. </li> <li class="seamTextUnorderedListItem">Hiltonol® (poly-ICLC) is an immune cell activating factor.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy routinely used to treat advanced and metastatic triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tremelimumab is a type of immunotherapy called a CTLA4 inhibitor.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03606967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search/Personalized%20Synthetic%20Long%20Pe/?searchMode=Begins' target='_blank'>NCI Drug Dictionary: Personalized Synthetic Long Peptide Breast Cancer Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com' target='_blank'>Oncovir Drug Information Page: Hiltonol® (poly-ICLC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Tremelimumab' target='_blank'>Wikipedia: Tremelimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/durvalumab' target='_blank'>NCI Drug Dictionary: Durvalumab (Imfinzi®)</a> </li></ul>

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 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: 86 miles
Pacific Cancer Care ( Site 0023)
Monterey,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: PDL1 (Immunotherapy) Tests</a> </li></ul>

NEAREST SITE: 158 miles
Local Institution
Fresno,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03471663

D-0502 Alone or in Combination With Palbociclib for Advanced ER+, HER2- Breast Cancer

A Phase I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad) and best dose of an experimental anti-estrogen therapy when it is given alone or in combination with palbociclib (Ibrance®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. 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">D-0502, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">D-0502, by mouth</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">D-0502 is the experimental anti-estrogen therapy used in this study.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is approved to treat hormone sensitive, HER2 negative breast cancer in combination with an anti-estrogen therapy in postmenopausal women. </li> <li class="seamTextUnorderedListItem">If you are premenopausal, you will also be given a therapy that will stop your ovaries from producing estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03471663' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/13_Supplement/5776' target='_blank'>AACR Abstract: D-0502</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com/?src_code=IBRW10028851' target='_blank'>Pfizer Oncology Drug Information Page: Ibrance® (Palbociclib)</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: 160 miles
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee,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: 171 miles
Carson Tahoe Regional Medical Center
Carson City,NV

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: 250 miles
Comprehensive Blood and Cancer Center Dept. of CBCC (2)
Bakersfield,CA

VISITS: 1 visit a week, ongoing

PHASE: III

NCT ID: NCT04251533

Chemotherapy Alone or with Alpelisib for Advanced Triple Negative Breast Cancer with a PIK3CA Mutation or PTEN Loss

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (EPIK-B3) Scientific Title

Purpose

To compare the safety and anti-cancer activity of giving the chemotherapy nab-paclitaxel (Abraxane®) alone or in combination with the targeted therapy Alpelisib (Piqray®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumors test positive for a PIK3CA mutation or PTEN loss and who have not received more than one chemotherapy 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">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) blocks the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA and PTEN loss</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04251533' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib</a> </li></ul>

NEAREST SITE: 273 miles
Samsum Clinic
Santa Barbara,CA

VISITS: 3 visits per month, ongoing

PHASE: II

NCT ID: NCT03961698

IPI-549, Atezolizumab, and Nab-paclitaxel for Advanced Triple Negative Breast Cancer

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination With Front-line Treatment Regimens in Patients With Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma Scientific Title

Purpose

To study the effects of IP-549 when it is used with atezolizumab (Tecentriq®) and paclitaxel (Abraxane®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-,PR-,HER2-) breast cancer that has not been treated with chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IPI-549, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IP-549 is a type of experimental targeted therapy called a PI3K-gamma inhibitor. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called a PD-L1 checkpoint inhibitor. It is approved to treat locally advanced or metastatic triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">Abraxane is a chemotherapy used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03961698' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.infi.com/home/our-development-program/ipi-549/' target='_blank'>Drug Company Information Page: IPI-549</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com/sclc.html?c=pdl-16d97f8fb9c&gclid=Cj0KCQiAtrnuBRDXARIsABiN-7Ap43URSS2rpiy3bh9KrbUqV-3pLCuvw7edYCY1v2MKoHoTdD369TUaArAsEALw_wcB&gclsrc=aw.ds' target='_blank'>Genentech Information Page: Tecentriq®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abraxane.com' target='_blank'>Drug Company Information Page: Abraxane®</a> </li></ul>

NEAREST SITE: 273 miles
Sansum Clinic
Santa Barbara,CA

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

PHASE: III

NCT ID: NCT04799249

Chemotherapy and an Investigational CDK 4/6 Inhibitor for Advanced Triple Negative Breast Cancer

A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2) Scientific Title

Purpose

To study and compare the safety, side effects, and anti-cancer activity of giving two chemotherapies with the investigational CDK 4/6 inhibitor trilaciclib (Cosela) to chemotherapy alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative breast cancer. You must have never received treatment for advanced disease and have never received an anti-PD-L1/PD-1 inhibitor. Or, your cancer must test positive for PD-L1, and your most recently received therapy must have been an anti-PD-L1/PD-1 inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Trilaciclib and chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), ongoing </li> </ul> Group 2: Placebo and chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela) is a type of targeted therapy called a CDK 4/6 inhibitor. Trilaciclib is approved for use in people with other types of cancer, but its use for breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and paraplatin are the chemotherapies used in this trial. They are routinely used to treat advanced and metastatic triple-negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04799249' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.g1therapeutics.com/pipeline/trilaciclib/' target='_blank'>G1 Therapeutics Drug Information Page: Trilaciclib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/gemcitabine.aspx' target='_blank'>Chemocare: Gemcitabine (Gemzar®)</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 (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>

NEAREST SITE: 273 miles
Samsun Clinic
Santa Barbara,CA

VISITS: 1 visit every month, ongoing

PHASE: II

NCT ID: NCT04829604

Antibody-Drug Conjugate ARX788 for Metastatic HER2 Positive Breast Cancer

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

Purpose

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

Who is this for?

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

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

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

VISITS: Every 3 weeks, ongoing

PHASE: II

NCT ID: NCT02778685

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of adding the immunotherapy drug pembrolizumab (Keytruda®) to the commonly used combination of the anti-estrogen drug letrozole (Femara®) and the CDK 4/6 inhibitor palbociclib (Ibrance®).

Who is this for?

Women with metastatic (stage IV) estrogen receptor positive (ER+) HER2 negative (HER2-) breast cancer who have not yet started treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and palbociclib (Ibrance®) are an already approved therapy combination. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is an anti-estrogen therapy. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02778685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com' target='_blank'>Pfizer Oncology Drug Information Page: Ibrance® (Palbociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwycfkBRAFEiwAnLX5IZ2WUInCzwQ56GHMYYq-KXijoX1dzOK1O8HBbmaxajT0CPi2CbX3sRoC3A4QA' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/the-evolving-field-of-erpositive-metastatic-breast-cancer-care' target='_blank'>Cure Today: The Evolving Field of ER Positive-Metastatic BC</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: 336 miles
UCLA Hematology-Oncology
Santa Monica,CA

VISITS: 1 visit every 3 or 4 weeks, ongoing

PHASE: I

NCT ID: NCT03255070

ARX788 for HER2 Positive Advanced Breast Cancer

A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression Scientific Title

Purpose

To evaluate the safety, effects (good and bad) and best dose of ARX788.

Who is this for?

People with HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies and has already been treated with trastuzumab (Herceptin®). Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788, by IV, every 3 or 4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARX788 is an antibody-drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">It uses an antibody that targets HER2 positive cancer cells to deliver a chemotherapy called amberstatin269 directly to these cells. </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/NCT03255070' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://ambrx.com/pipeline/arx788-aher2-adc-oncology/' target='_blank'>Drug Company Information Page: ARX788 HER2 ADC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-antibody-drug-conjugate-arx788' target='_blank'>NCI Drug Dictionary: ARX788</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: 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 Trop-2 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
University of California Los Angeles (UCLA).
Los Angeles,CA

VISITS: 2 visits a month, for as long as benefit is shown

PHASE: I

NCT ID: NCT03667716

COM701 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity, best dose, and side effects of giving COM701 alone or in combination with nivolumab (Opdivo®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer who have already received at least one chemotherapy for advanced disease and a PARP inhibitor if they have an inherited BRCA1/2 mutation. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">COM701, by IV, once every 4 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">COM701, by IV, once every 4 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">COM701 is an experimental immunotherapy that targets the PVRIG pathway. </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. 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/NCT03667716' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cgen.com/clinical-trials/' target='_blank'>Compugen Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pvrig-monoclonal-antibody-com701' target='_blank'>NCI Drug Dictionary: COM701</a> </li></ul>

100

NEAREST SITE: 336 miles
UCLA Hematology & Oncology Clinic
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03849469

XmAb®22841 and Pembrolizumab in Advanced Triple Negative Breast Cancer

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4) Scientific Title

Purpose

To determine the best dose, safety and effects of XmAb22841 when it is used alone or in combination with pembrolizumab (Keytruda®).

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: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®22841</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®22841</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb22841 is a new type of immunotherapy that targets CTLA-4 and LAG-3. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to certain types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study 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/NCT03849469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.xencor.com/pipeline/' target='_blank'>Drug company information page: XmAb®22841</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/latest-news/fda-approves-keytruda-pembrolizumab-for-any-tumor-with-specific-genetic-change.html' target='_blank'>Cancer.org: FDA Approves Keytruda (Pembrolizumab) for Any Tumor with Specific Genetic Change</a> </li></ul>

101

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04115306

Targeted Therapy PMD-026 for Metastatic Triple Negative Breast Cancer

Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To determine the best dose, safety, and effects of the drug PMD-026.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04115306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://phoenixmd.ca/pipeline' target='_blank'>Drug Company Information Page: PMD-026</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29498411' target='_blank'>PubMed Abstract: RSK1 Promotes Murine Breast Cancer Growth and Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Ribosomal_s6_kinase' target='_blank'>Wikipedia: RSK</a> </li></ul>

102

NEAREST SITE: 336 miles
University of California at Los Angeles Reg-5
Los Angeles,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT04208178

Alpelisib for Advanced HER2+ Breast Cancer with a PIK3CA Mutation

EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation Scientific Title

Purpose

To study the best dose and anti-cancer activity of combining the PI3K inhibitor alpelisib (Piqray®) with the anti-HER2 therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer that tests positive for a PIK3CA mutation. You must have already received chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, once every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, once every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, once every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow. </li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) blocks the PI3K pathway. </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> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04208178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/alpelisib-changing-clinical-landscape-breast-cancer-treatment' target='_blank'>Cancer Network: Alpelisib Is Changing the Clinical Landscape in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/tucatinib-trastuzumab-deruxtecan-her2-positive-metastatic-breast-cancer' target='_blank'>NCI Cancer Currents Blog: For Metastatic HER2-Positive Breast Cancer, New Treatments Emerge</a> </li></ul>

103

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>

104

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT04297020

Studying the Effects of Anti-Estrogen Therapy on the Brain of Women with Stage I-III Breast Cancer

Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy Scientific Title

Purpose

To see if anti-estrogen therapy affects brain health.

Who is this for?

Women between the ages of 35 and 65 who are currently taking anti-estrogen therapy for stage I, stage II, or stage III breast cancer and who did not receive chemotherapy. This trial is also enrolling women who have never been diagnosed with breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 Brain fMRI (functional MRI)</li> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will use an advanced brain MRI technique called functional MRI (fMRI).</li> <li class="seamTextUnorderedListItem">fMRI measures changes in blood flow that happen during mental activity. </li> <li class="seamTextUnorderedListItem">Research suggests that the cognitive issues experienced by some women who receive treatment for breast cancer--also called <q>chemo brain</q>--may actually be caused by anti-estrogen therapy and not chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04297020' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/932091' target='_blank'>MedScape: In Breast Cancer, Is Chemobrain Really Endocrine Brain?</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Functional_magnetic_resonance_imaging' target='_blank'>Wikipedia: Functional MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info.cfm?pg=fmribrain' target='_blank'>RadiologyInfo.org: fMRI</a> </li></ul>

105

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT04460495

Comparing Oxygen Use by Tumor Cells vs. Normal Cells in the Brain

Quantifying Tumor Respiration Using Oxygen-Enhanced Molecular MRI Scientific Title

Purpose

To determine if a special type of MRI imaging can help scientists understand how cancer cells in the brain use oxygen differently than normal cells.

Who is this for?

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

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You will receive the following over 60 minutes: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI brain scan while breathing normal air</li> <li class="seamTextUnorderedListItem">MRI brain scan while breathing air with a high concentration of oxygen</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oxygen-Enhanced Molecular Magnetic Resonance Imaging (MRI) is being studied to see if it can distinguish brain tumor cells, including metastases, from normal cells based on how they utilize oxygen. </li> <li class="seamTextUnorderedListItem">This MRI may help to detect brain tumor cells and evaluate new drugs that target cancer cell metabolism.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04460495' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>

106

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>

107

NEAREST SITE: 338 miles
Sarcoma Oncology Center
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02568267

Basket Study of Entrectinib in Tumors With a NTRK1/2/3, ROS1, or ALK Mutation

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements Scientific Title

Purpose

To study the effects (good and bad) of entrectinib (Rozlytrek®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Your tumor must test positive for or express one of the following: NTRK 1/2/3, ROS 1, or ALK mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Basket studies enroll people based on the kind of mutations found in their tumors. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer whose tumors test positive for certain mutations.</li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK 1/2/3, ROS1, and ALK</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02568267' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rozlytrek.com/?c=ent-16b05ae9ce6&gclid=Cj0KCQjw-_j1BRDkARIsAJcfmTHfl5vGlhgj7U1G_eLElm-4GOU_P5TcEhf6NBVhkZbfVZ07uc4f9UwaAnOiEALw_wcB&gclsrc=aw.ds' target='_blank'>Genentech Information Page: Rozlytrek® (Entrectinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Entrectinib' target='_blank'>Wikipedia: Entrectinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/fda-entrectinib-ntrk-fusion' target='_blank'>NCI Cancer Currents Blog: FDA Approves Entrectinib Based on Tumor Genetics Rather Than Cancer Type</a> </li></ul>

108

NEAREST SITE: 338 miles
Sarcoma Oncology Research Center
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03422679

Experimental Targeted Therapy CB-103 for Advanced Triple Negative Breast Cancer

A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study With Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway (NC... Scientific Title

Purpose

To study the safety, side effects, and anti-cancer activity of the experimental targeted therapy CB-103 that can be taken by mouth.

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">CB-103, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CB-103 is a NOTCH pathway inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03422679' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cellestia.com/the-pipeline/' target='_blank'>Cellestia Drug Information Page: CB-103</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.TPS2619' target='_blank'>ASCO Abstract: CB-103</a> </li></ul>

109

NEAREST SITE: 338 miles
Sarcoma Oncology Research Center LLC
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04293094

AMG 650 for People With Advanced Triple Negative Breast Cancer

A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of the experimental drug AMG 650.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have had at least one chemotherapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: AMG 650, by mouth, ongoing
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is also enrolling people 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/NCT04293094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

110

NEAREST SITE: 339 miles
UCLA School of Medicine
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT01351103

LGK974 and PDR001 for Advanced Triple Negative Breast Cancer

A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands Scientific Title

Purpose

To study the best dose and effects (good and bad) of using the experimental targeted therapy LGK974 (WNT974) in combination with the experimental immunotherapy PDR001 (spartalizumab).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LGK974 (WNT974), by mouth</li> <li class="seamTextUnorderedListItem">PDR001 (spartalizumab), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Wnt pathway is a network of proteins that may play a role in how cancer develops. </li> <li class="seamTextUnorderedListItem">LGK974 (WNT974) is a targeted therapy designed to inhibit the Wnt pathway.</li> <li class="seamTextUnorderedListItem">PDR001 (spartalizumab) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced or metastatic cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01351103' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/cancer-frontline/phase-i-clinical-trial-shows-wnt974-in-combination-with-spartalizumab-well-tolerated-for-advanced-solid-tumor-patients.h00-159381156.html' target='_blank'>MD Anderson Cancer Center: Phase I clinical trial shows WNT974 in combination with spartalizumab well tolerated for advanced solid tumor patients</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/porcupine-inhibitor-wnt974' target='_blank'>NCI Drug Dictionary: LGK974 (WNT974)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: PDR001 (Spartalizumab)</a> </li></ul>

111

NEAREST SITE: 339 miles
UCLA Hematology/Oncology - Santa Monica
Santa Monica,CA

VISITS: Weekly visits for 2 months, monthly visits thereafter

PHASE: II

NCT ID: NCT03519178

PF-06873600 for Metastatic HER2-Negative Breast Cancer

Phase 1/2a Dose Escalation And Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics And Anti-tumor Activity Of Pf-06873600 As A Single Agent And In Combination With Endocrine Therapy Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of PF-06873600, a new targeted therapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor (ER+ and/or PR+) positive, HER2 negative (HER2-) breast cancer who have already received a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600, by mouth</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600, by mouth</li> <li class="seamTextUnorderedListItem">Endocrine therapy</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600 is a cyclin-dependent kinase (CDK) inhibitor. </li> <li class="seamTextUnorderedListItem">It works by inhibiting the CDK enzymes that help cancer cells grow. </li> <li class="seamTextUnorderedListItem">Patients in the study with hormone-receptor positive breast cancer will also be treated with an 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/NCT03519178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793673' target='_blank'>NCI Drug Dictionary: PF-06873600</a> </li></ul>

112

NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03665285

NC318 for Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the best dose, safety, and effects (good and bad) of an experimental cancer drug called NC318.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has low levels of the protein PD-L1 and 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">NC318, by injection</li> </ul> Please contact research site for treatment schedule Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 or 2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NC318 is designed to block a protein, called S15, that keeps the immune system from killing cancer cells. </li> <li class="seamTextUnorderedListItem">Blocking this protein could help the immune system see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">This study 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/NCT03665285' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796496' target='_blank'>NCI Drug Dictionary: NC318</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.nextcure.com/pipeline/' target='_blank'>Drug Company Information Page: NC318</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808' target='_blank'>Mayo Clinic: Monoclonal Antibody Drugs for Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2018/03/monoclonal-antibody-therapy-cancer/' target='_blank'>Dana-Farber Cancer Institute: What is Monoclonal Antibody Therapy for Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/keytruda-faq/what-are-pd1-and-pdl1/' target='_blank'>Merk Oncology: What are PD-1 and PD-L1?</a> </li></ul>

113

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>

114

NEAREST SITE: 339 miles
UCLA Department of Medicine - Hematology/Oncology
Santa Monica,CA

VISITS: Number of visits unavailable, ongoing

PHASE: I-II

NCT ID: NCT03729596

Targeted Therapy MGC018 Alone or with Immunotherapy MGA012 in Advanced Triple Negative Breast Cancer

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad) and anti-cancer activity of the experimental antibody-drug conjugate MC108 given alone or given with the experimental PD-1 inhibitor MGA012.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have already received at least one therapy. Full eligibility criteria

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

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC018, by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC018, by IV, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MC108 is an experimental antibody-drug conjugate (ADC)--it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">In MC108, the antibody targets B7-H3 proteins and delivers the chemotherapy duocarmycin.</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor or 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 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/NCT03729596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mgc018-b7-h3/' target='_blank'>MacroGenics Drug Information Page: MGC018</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3071' target='_blank'>ASCO Abstract: MGC018 (anti-B7-H3 antibody-drug conjugate) in Patients with Advanced Solid Tumors.</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Duocarmycin' target='_blank'>Wikipedia: Duocarmycin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>MacroGenics Drug Information Page: MGA012 (Retifanlimab)</a> </li></ul>

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NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute
Los Angeles,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT04025216

CAR-T Immunotherapy for Metastatic Triple Negative & ER-Low, HER2- Breast Cancer that is TnMUC1-Positive

A Phase 1 Open-Label, Multi-Center First in Human Study of TnMUC1-Targeted Genetically-Modified Chimeric Antigen Receptor T Cells in Patients With Advanced TnMUC1-Positive Solid Tumors and Multiple Myeloma Scientific Title

Purpose

To study the safety, best dose, side effects (good and bad), and anti-cancer activity of a new CAR-T cell immunotherapy that targets cancer cells that test positive for MUC1.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for the antigen TnMUC1. Full eligibility criteria