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(Last updated: April 03, 2020)

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1

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <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 <span class="highlight">microenvironment</span> (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>
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2

NEAREST SITE: 366 miles
Novartis Investigative Site
Santa Monica,CA

VISITS: At least 1 visit per month

PHASE: II

NCT ID: NCT03207867

Combination Immunotherapies for Advanced Triple Negative Breast Cancer

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma Scientific Title

Purpose
To study the safety and effects (good and bad) of using two different types of immunotherapy drugs at the same time to treat advanced triple negative breast cancer.
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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIR178, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">PDR001, by IV, monthly, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two experimental immunotherapies being used in this study are NIR178 and PRD001.</li> <li class="seamTextUnorderedListItem">NIR178 is an adenosine receptor antagonist. It blocks adenosine, which is found in the <span class="highlight">microenvironment</span> that surrounds the tumor. </li> <li class="seamTextUnorderedListItem">PDR001 is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">This trial is also 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/NCT03207867' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/understanding-immunotherapy' target='_blank'>Cancer.net: Understanding Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pdr001/' target='_blank'>Immuno-Oncology News: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/news/media-releases/novartis-continues-grow-immuno-oncology-pipeline-through-collaboration-and' target='_blank'>Novartis: NIR178</a> </li></ul>
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3

NEAREST SITE: 1387 miles
Stephenson Cancer Center
Oklahoma City,OK

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03775850

Immunotherapy EDP1503 With Pembrolizumab For Advanced Triple Negative Breast Cancer

A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors Scientific Title

Purpose
To assess the safety and the effects (good and bad) of the immunotherapy EDP1503 when it is given along with pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other approved treatment options available.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 alone, by mouth, twice daily for 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">followed by</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 alone, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 is an experimental immunotherapy that may work by changing the <span class="highlight">microenvironment</span> that surrounds the cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is only 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/NCT03775850' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795263' target='_blank'>NCI: Monoclonal microbial EDP1503</a> </li><li class='seamTextUnorderedListItem'><a href='https://globenewswire.com/news-release/2019/01/04/1680530/0/en/Evelo-Biosciences-Announces-Dosing-of-First-Patient-in-Phase-1-2-Clinical-Trial-of-EDP1503-in-Combination-with-KEYTRUDA-pembrolizumab-in-Multiple-Oncology-Indications.html' target='_blank'>Evelo Press Release: EDP1503</a> </li></ul>
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4

NEAREST SITE: 2569 miles
Columbia University Medical Center
New York,NY

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03165487

Breast Tissue Study in Women 50 and Older Having a Lumpectomy

Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment Scientific Title

Purpose
To identify and compare molecular markers in the normal breast tissue surrounding a breast cancer tumor to determine if this tissue affects how the tumor behaves.
Who is this for?
Women with stage I or stage II HER2 negative breast cancer. You must also be at least 50, have had a mammogram within the past six months, and be receiving treatment at the Breast Surgery and Radiation Oncology Clinics of Columbia University.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will undergo the following during surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 tissue and blood samples will be collected, before and after intraoperative radiotherapy (radiation immediately after surgery)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The breast tissue around a tumor--called the <span class="highlight">microenvironment</span>--may affect how the tumor responds to treatments and how likely it is to come back (recur). </li> <li class="seamTextUnorderedListItem">To analyze the <span class="highlight">microenvironment</span> the researchers will measure the number of tumor-infiltrating Lymphocites (white blood cells) before and after you recieve intraoperative radiotherapy (IORT).</li> <li class="seamTextUnorderedListItem">To measure the tumor-infiltrating Lymphocites, breast tissue will be collected before and after IORT. </li> <li class="seamTextUnorderedListItem">Intraoperative radiatiotherapy is a radiation treatment delivered during surgery immediately after the tumor has been removed and is the standard of care for breast conserving surgery (lumpectomy).</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03165487' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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5

NEAREST SITE: 2569 miles
Columbia University Medical Center
New York,NY

VISITS: 3 visits over 2 months

PHASE: I

NCT ID: NCT02977468

Keytruda and Radiation Therapy for Early Stage Triple Negative Breast Cancer

Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer With and Without Intra-operative RT: a Window of Opportunity Study Scientific Title

Purpose
To study the effects (good and bad) that the immunotherapy drug pembrolizumab (Keytruda®) has on triple negative cancer cells. The researchers will also study the effect radiation given during surgery has on breast cancer cells treated with immunotherapy.
Who is this for?
Women who have been recently diagnosed with stage I, stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who have not received any treatment for their cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice over 6 weeks </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiation therapy (IORT) during surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving a drug before surgery allows doctors to study the effect the drug has on cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of lung, head and neck, blood cancers, and other solid tumors. </li> <li class="seamTextUnorderedListItem">The radiation treatment, called intraoperative radiation therapy (IORT), delivers a high dose of radiation to the area where the tumor was removed.</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02977468' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/20659' target='_blank'>ASCO Post: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation/types/intraoperative' target='_blank'>Breastcancer.org: Intraoperative Radiation Therapy (IORT)</a> </li></ul>
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