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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.

Visit COVID-19 & Cancer Clinical Trials on Metastatic Trial Talk for regularly updated information about clinical trials during the coronavirus pandemic.


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(Last updated: January 11, 2022)

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1

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> Participants will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) or Carboplatin (Paraplatin®) by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: No intervention</i> </p> <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 <span class="highlight">triple</span> <span class="highlight">negative</span> as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Most <span class="highlight">triple</span>-<span class="highlight">negative</span> 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 <span class="highlight">triple</span>-<span class="highlight">negative</span> 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>
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2

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> Participants will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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 <span class="highlight">triple</span>-<span class="highlight">negative</span> 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>
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3

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

VISITS: 21 visits over 2 years

PHASE: III

NCT ID: NCT03562637

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

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

Purpose
To study the safety and anti-cancer activity of giving a combination of two experimental immunotherapies after the standard of care has been completed.
Who is this for?
People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have completed chemotherapy. You must have had cancer cells remaining if you had neoadjuvant (before surgery) chemotherapy or had 4 or more positive lymph nodes at the time of surgery if you had adjuvant (after surgery) chemotherapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) combined with OBI-821, by injection, 21 times over 2 years </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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 <span class="highlight">triple</span> <span class="highlight">negative</span> 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>
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4

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Chemotherapy with Atezolizumab</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Chemotherapy alone </i> </p> <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 <span class="highlight">triple</span> <span class="highlight">negative</span> (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>
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5

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

VISITS: Number of visits unavailable, over 2 months

PHASE: II

NCT ID: NCT03546686

Immunotherapy & Cryoablation Before Surgery in Taxane Treated Triple Negative or ER-Low, HER2- Tumors

A Randomized Phase 2 Study of Peri-Operative Ipilimumab, Nivolumab and Cryoablation Versus Standard Peri-Operative Care in Women With Hormone Receptor-Negative, HER2-Negative Early Stage/Resectable Breast Cancer. Scientific Title

Purpose
To study the safety and effects (good and bad) of using cryoablation, ipilimumab (Yervoy®) and nivolumab (Opdivo ®) after neoadjuvant chemotherapy and before surgery.
Who is this for?
Women with stage I, stage II, or stage IIIa triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who had taxane-based chemotherapy before surgery and still have some tumor remaining.    Full eligibility criteria
Contact research site
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Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, 1-5 days prior to core biopsy and cryoablation</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, 1-5 days prior to core biopsy and cryoablation, and then every 2 weeks after surgery, for 6 weeks</li> <li class="seamTextUnorderedListItem">Core biopsy/Cryoablation, 7-10 days prior to surgery</li> <li class="seamTextUnorderedListItem">Breast surgery (standard-of-care) </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cryoablation uses extreme cold to kill cancer cells. It is not an established breast cancer treatment. </li> <li class="seamTextUnorderedListItem">Yervoy is an immunotherapy. It gets the immune system to see cancer cells by blocking the CTLA-4 protein. It is approved to treat metastatic melanoma. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Opdivo is an immunotherapy that gets the immune system to go after cancer cells by blocking a protein called PD-1. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</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 women with <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT03546686' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/ipilimumab-yervoy' target='_blank'>Cancer Research UK: Ipilimumab (Yervoy)</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.breastcancer.org/treatment/surgery/cryotherapy' target='_blank'>Breastcancer.org: Cryotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2018/11/181128082721.htm' target='_blank'>Science Daily: Cryoablation</a> </li></ul>
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6

NEAREST SITE: 353 miles
City of Hope Comprehensive Cancer Center
Duarte,CA

VISITS: Monthly visits, ongoing

PHASE: II

NCT ID: NCT03012100

Vaccine and Chemotherapy to Prevent Recurrence in Women With Stage I-III Triple Negative or ER-Low, HER2- Breast Cancer

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer Scientific Title

Purpose
To compare the safety and effects (good and bad) of giving the chemotherapy cyclophosphamide (Cytoxan®) alone to giving it with an experimental vaccine.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer.    Full eligibility criteria
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Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by mouth, daily (every other week), for 1 month </li> <li class="seamTextUnorderedListItem">followed by vaccine and sargramostim, by injection, monthly, for 6 months, then every 6 months, for about 5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan), by mouth, daily (every other week), for 1 month </li> <li class="seamTextUnorderedListItem">followed by placebo and sargramostim, by injection, monthly, for 6 months, then every 6 months, for about 5 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The experimental vaccine used in this trial is called a FR alpha peptide vaccine. It is a personalized vaccine made by removing some of your white blood cells and mixing them in a lab with tumor proteins. </li> <li class="seamTextUnorderedListItem">The vaccine is a type of immunotherapy--it may help your immune system to find and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Sargramostim (GM-CSF) helps prevent neutropenia--a low white blood cell count that increases your risk for infection.</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 women with <span class="highlight">triple</span> <span class="highlight">negative</span> as well as ER-Low, HER2 <span class="highlight">negative</span> breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03012100' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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7

NEAREST SITE: 538 miles
Providence Portland Medical Center
Portland,OR

VISITS: 1 visit a week, for 6 to 7 months before surgery

PHASE: II

NCT ID: NCT04373031

Chemotherapy and Immunotherapy before Surgery for Stage II-III Triple-Negative Breast Cancer

Induction Immunotherapy to Promote Immunologic Priming and Enhanced Response to Neoadjuvant Pembrolizumab + Chemotherapy in Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose
To study the anti-cancer activity and safety of giving immunotherapy and chemotherapy before surgery.
Who is this for?
People with stage II or stage III triple-negative (ER-, PR-, HER2-) breast cancer. You must not have already received treatment, including surgery, for this 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 be randomly assigned to 1 of 2 groups and receive the following before surgery for up to 7 months: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 time</li> <li class="seamTextUnorderedListItem">followed by pembrolizumab, by IV, every 3 weeks and paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">followed by pembrolizumab, doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®), by IV, every 3 weeks, for 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab and cyclophosphamide, by IV, 1 time</li> <li class="seamTextUnorderedListItem">IRX-2, by injection, 2 times a day, for 10 days</li> <li class="seamTextUnorderedListItem">followed by pembrolizumab, by IV, every 3 weeks and paclitaxel, by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">followed by IRX-2, by injection, 2 times a day, for 10 days</li> <li class="seamTextUnorderedListItem">followed by pembrolizumab, doxorubicin, and cyclophosphamide every 3 weeks, for 3 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapies (treatments given before surgery) are used to study how the therapies affect your particular tumors. </li> <li class="seamTextUnorderedListItem">IRX-2 is an experimental immunotherapy that may act as an immune booster to stimulate the immune system.</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 PD-1. Pembrolizumab is approved for use in people with metastatic <span class="highlight">triple</span>-<span class="highlight">negative</span> breast cancer, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapies commonly 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/NCT04373031' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/chemo-before-sx-makes-tnbc-eligible-for-lx' target='_blank'>Breastcancer.org: More Evidence That Chemotherapy Before Surgery Can Make Triple-Negative Breast Cancer Eligible for Lumpectomy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/understanding-immunotherapy-for-early-tnbc' target='_blank'>Breastcancer.org: Immunotherapy for Early-Stage Triple-Negative Breast Cance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/first-trial-of-immunotherapy-in-early-stage-triple-negative-breast-cancer-shows-promising' target='_blank'>Targeted Oncology: First Trial of Immunotherapy in Early-Stage Triple-Negative Breast Cancer Shows Promising Results</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.brooklynitx.com/science-of-irx-2/' target='_blank'>Brooklyn ImmunoTherapeutics Drug Information Page: IRX-2</a> </li></ul>
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8

NEAREST SITE: 600 miles
University of Utah Sugarhouse Health Center
Salt Lake City,UT

VISITS: 5 visits a week, for 5 to 6 weeks

PHASE: I

NCT ID: NCT04052555

M6620 & Radiation Therapy for People with HER2- Breast Cancer Who Have Leftover Tumor Cells After Receiving Chemotherapy

A Phase 1b Study of M6620 in Combination With Radiation Therapy to Overcome Therapeutic Resistance in Chemotherapy Resistant Triple Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity and effects (good and bad) of giving the experimental targeted therapy M6620 during radiation therapy.
Who is this for?
People with stage I, stage II, or stage III, HER2 negative (HER2-) breast cancer who still had some tumor remaining after they received neoadjuvant (before surgery) chemotherapy.    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">M6620, by IV, twice a week, for 5 weeks</li> <li class="seamTextUnorderedListItem">Radiation Therapy, 5 days a week, for 5 to 6 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Follow up visits</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Weekly, for 1 month</li> <li class="seamTextUnorderedListItem">Once a year, for 3 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M6620 is an experimental drug that researchers believe makes radiation therapy more able to kill cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04052555' target='_blank'>ClinicalTrials.gov</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'>ASCO: Residual Cancer Burden Is Prognostic of Outcomes Across Breast Cancer Subtypes</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Radiosensitizer' target='_blank'>Wikipedia: Radiosensitizer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-vx-970' target='_blank'>NCI Drug Dictionary: M6620</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/30166399' target='_blank'>Journal Abstract: ATR Inhibition Is a Promising Radiosensitizing Strategy for Triple-Negative Breast Cancer</a> </li></ul>
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9

NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03979508

Abemaciclib Before Surgery for Women with Stage I-III, Triple Negative or ER-Low, HER2- Breast Cancer That Did Not Respond to Chemotherapy

Window Trial of Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer (a BEAUTY Study*) Scientific Title

Purpose
To study the safety and effects of using the CDK 4/6 inhibitor abemaciclib (Verzenio®) after neoadjuvant chemotherapy and before surgery.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR- HER2-) or ER-Low (1%-10% ER), HER2- breast cancer that did not fully respond to chemotherapy given before surgery.    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 before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, for 2 to 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</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 women with <span class="highlight">triple</span> <span class="highlight">negative</span> as well as ER-Low, HER2- breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor approved to treat HR+ and HER2- metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">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/NCT03979508' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: What Are CDK4/6 Inhibitors?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/?utm_source=google&utm_medium=ppc&campaign=6456675261&adgroup=82640243172&ad=378689406892&utm_keyword=kwd-389189556877&gclid=Cj0KCQiAmsrxBRDaARIsANyiD1qSisgRZtObbCNg3aCVnfoCwqXFjJlXYQsig6GLWR1OKy3oM7jjYJIaAtcqEALw_wcB' target='_blank'>Eli Lilly and Company Drug Information Page: Verzenio® (Abemaciclib)</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://metastatictrialtalk.org/2018/09/01/mbc-news-3/' target='_blank'>Metastatic Trial Talk: Insights Into Treatment Resistance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6523967/' target='_blank'>Journal Article: Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer</a> </li></ul>
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10

NEAREST SITE: 666 miles
University of Washington Medical Center
Seattle,WA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02993068

Stand up to Cancer: Making Genetic Testing Accessible

Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible) Scientific Title

Purpose
To study four approaches to providing education about genetic risk for cancer.
Who is this for?
Women, age 30 or over, with at least one ovary, a history of breast cancer or considered at high risk for breast cancer, and planning to be tested for a breast cancer-related genetic mutation.    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 randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video before the testing</li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video before the genetic testing </li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report with telephone genetic counseling</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video with telephone genetic counseling before the testing</li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report with telephone genetic counseling </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video with telephone genetic counseling before the testing</li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The researchers will see what effects the programs have on a woman's understanding of genetics and quality of life.</li> <li class="seamTextUnorderedListItem">The study is using FDA-approved saliva-testing kits and genetic tests.</li> <li class="seamTextUnorderedListItem">To be eligible for this study, you must meet one of the following: diagnosed with breast cancer at 45 or younger; diagnosed with <span class="highlight">triple</span> <span class="highlight">negative</span> (ER-, PR-, HER2-) breast cancer at 60 or younger; have one blood relative with a mutation in BRCA 1, BRCA 2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2; have one relative with ovarian cancer; have at least 2 relatives with breast cancer on the same side of the family, one of which is 50 years of age or less; or have one male relative with breast cancer.</li> <li class="seamTextUnorderedListItem">Any woman who tests positive for a genetic mutation will have the ability to speak with a genetic counselor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02993068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://magenta.mdanderson.org' target='_blank'>MD Anderson Cancer Center Study Information: MAGENTA</a> </li></ul>
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11

NEAREST SITE: 752 miles
University of Arizona Cancer Center
Tucson,AZ

VISITS: Number of visits unavailable, over 3 weeks

PHASE: NA

NCT ID: NCT03911453

PARP Inhibitor Rucaparib Before Surgery in Patients with Triple Negative or ER-Low, HER2- Breast Cancer

Window of Opportunity Trial to Evaluate Change in PD-L1 Expression in Triple Negative Breast Tumors in Response to the PARP Inhibitor Rucaparib Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of the PARP inhibitor rucaparib (Rubraca®) when it is given before surgery.
Who is this for?
People with stage I, stage II or stage III triple negative (ER-, PR- and HER2-) or ER-Low (1%-10% ER) breast cancer who are scheduled to have breast cancer surgery.    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®), by mouth, twice daily, for 3 weeks before surgery</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Possible biopsy before treatment</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rubraca is a targeted therapy that has been approved to treat ovarian cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Giving the drug before surgery allows researchers to study the effect that it has on 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 <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT03911453' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/02/04/mbc-news-8/' target='_blank'>MetastaticTrialTalk.org: Get the Latest News on PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20090531' target='_blank'>Breastcancer.org: New Type of Targeted Therapy May Help TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/rucaparib.aspx' target='_blank'>Chemocare: Rucaparib</a> </li></ul>
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12

NEAREST SITE: 1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays,KS

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

A Registry for People with Triple Negative or ER-Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT) Scientific Title

Purpose
To learn more about the relationship between genetic mutations and cancer outcomes.
Who is this for?
People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer.    Full eligibility criteria
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  • How can I learn more?
  • <p class="seamTextPara"> This is a data collection (registry) study. You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</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 <span class="highlight">triple</span> <span class="highlight">negative</span> as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between <span class="highlight">triple</span> <span class="highlight">negative</span> breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</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://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>
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13

NEAREST SITE: 1482 miles
Texas Oncology- Baylor
Dallas,TX

VISITS: 1 visit every 3 weeks for 4.5 months

PHASE: II

NCT ID: NCT03639948

Immunotherapy and Chemotherapy Before Surgery to Treat Triple Negative Breast Cancer

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer (NeoPACT) Scientific Title

Purpose
To study the effect of using the immunotherapy pembrolizumab (Keytruda®) along with chemotherapy before surgery (neoadjuvant therapy).
Who is this for?
People with stage I, II or III triple-negative (ER-/PR-/HER2-) breast cancer who have not yet started treatment.    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">Carboplatin (Paraplatin®), by IV</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> <li class="seamTextUnorderedListItem">Pegfilgrastim, by injection </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">All medications are given once every 3 weeks, for 4.5 months</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">It stimulates the body's immune system to go after cancer cells. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and docetaxel (Taxotere®) are chemotherapy drugs used to treat <span class="highlight">triple</span> <span class="highlight">negative</span> breast cancer. </li> <li class="seamTextUnorderedListItem">Pegfilgrastim is a human granulocyte colony-stimulating factor (GCSF). It is given along with chemotherapy to reduce the risk of neutropenia (low white blood cell count) and infection.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03639948' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/immunotherapy-remains-focal-point-in-tnbc' target='_blank'>OncLive: Immunotherapy Remains Focal Point in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Pembrolizumab Moving Forward in Triple-Negative Breast Cancer</a> </li></ul>
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14

NEAREST SITE: 1509 miles
University of Texas Southwestern Medical Center
Dallas,TX

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04041128

PARP Inhibitor Before Surgery in Women with Triple Negative Breast Cancer & Inherited BRCA1/2 Mutation

Pre-Surgical Window Pilot Investigation of the Effect of PARP Inhibition on the Cellular and Molecular Changes in Primary Ovarian and Breast Cancer Scientific Title

Purpose
To study the effect that olaparib (Lynparza®) has on breast cancer cells when it is given before surgery.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR- and HER2-) breast cancer who have an inherited BRCA 1/2 mutation and who have not received any other breast cancer therapies.    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">Olaparib (Lynparza®), by mouth, twice daily, for 7 days before surgery</li> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor that is approved to treat HER2-<span class="highlight">negative</span> metastatic breast cancer in women with an inherited BRCA mutation. </li> <li class="seamTextUnorderedListItem">This study is also enrolling women with ovarian cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04041128' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/breast-cancer/how-lynparza-treats-breast-cancer.html' target='_blank'>AstraZeneca Drug Information Page: Lynparza® (Olaparib)</a> </li></ul>
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15

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: Weekly study visits during radiation treatment

PHASE: NA

NCT ID: NCT02945579

Neoadjuvant Chemo & Radiation But No Surgery for Stage I-II Triple Negative or ER-Low, HER2- or HER2 Positive Breast Cancer

Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy Scientific Title

Purpose
To study the effects (good and bad) of avoiding surgery but still using radiation therapy in women whose biopsy shows their tumor disappeared after they received neoadjuvant chemotherapy.
Who is this for?
Women 40 or older with stage I or stage II triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) or HER2 positive (HER2+) breast cancer. You must have already had chemotherapy to shrink your tumor, but no other treatments    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">An image-guided biopsy (a biopsy that uses imaging such as CT, ultrasound, MRI or mammography)</li> <li class="seamTextUnorderedListItem">If the biopsy does not show any evidence of disease, you will then have radiation therapy</li> <li class="seamTextUnorderedListItem">If the biopsy show evidence of disease, you will have surgery then radiation therapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink tumors before surgery. The tumor may even disappear. When this occurs, researchers think it may be possible for patients to avoid surgery.</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 women with <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT02945579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>
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16

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Visits weekly for 3 months

PHASE: II

NCT ID: NCT02689427

Xtandi and Taxol Before Surgery for Stage I-III Triple Negative or ER-Low, HER2- Breast Cancer that is Androgen Receptor Positive

A Phase IIB Study of Neoadjuvant Enzalutamide (ZT) Regimen Therapy in Combination With Weekly Paclitaxel for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer Scientific Title

Purpose
To look at the safety and anti-cancer activity of giving an anti-androgen drug along with chemotherapy before surgery.
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 that is androgen receptor positive (AR+).    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 before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</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 <span class="highlight">triple</span> <span class="highlight">negative</span> as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Androgen receptors (AR) are found on many <span class="highlight">triple</span>-<span class="highlight">negative</span> breast tumors.</li> <li class="seamTextUnorderedListItem">Researchers think drugs that blocking these receptors could keep breast cancer cells from growing.</li> <li class="seamTextUnorderedListItem">The anti-androgen drug that will be used in this study is enzalutamide (Xtandi®). It is currently used to treat prostate cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AR (androgen receptor)</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02689427' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/about-cancer/treatment/drugs/enzalutamide' target='_blank'>NCI Drug Drug Dictionary: Xtandi</a> </li></ul>
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17

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03872388

Atorvastatin in Stages IIb-III Triple Negative or ER-Low, HER2- Breast Cancer After Neoadjuvant Therapy & Surgery

Atorvastatin in Triple-Negative Breast Cancer (TNBC) Patients Who Did Not Achieve a Pathologic Complete Response (pCR) After Receiving Neoadjuvant Chemotherapy, a Multicenter Pilot Study Scientific Title

Purpose
To study the effects (good and bad) of atorvastatin (Lipitor®).
Who is this for?
People with stage IIb or stage III triple negative (ER-, PR- and HER2-) or ER-Low (1%-10% ER) breast cancer that did not fully respond to neoadjuvant chemotherapy (treatment given before surgery).    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">Atorvastatin, by mouth, once a day, for up to 2 years</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times daily, 2 weeks on and 1 week off </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times daily, 2 weeks on and 1 week off</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atorvastatin (Lipitor®) is used to treat high cholesterol and may also be effective in treating <span class="highlight">triple</span> <span class="highlight">negative</span> breast cancer. </li> <li class="seamTextUnorderedListItem">Your doctor will decide whether you should receive the breast cancer drug capecitabine (Xeloda®) while you are in this study.</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 <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT03872388' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/atorvastatin.html' target='_blank'>Drugs.com: Atorvastatin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/community/bonnie-annis/2018/03/do-statins-contribute-to-cancer-recurrence' target='_blank'>Cure today: Do Statins Contribute to Cancer Recurrence?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/889813' target='_blank'>Medscape: Statins May Up Breast Cancer–Specific and Overall Survival</a> </li></ul>
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18

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Visits weekly over 3 months

PHASE: II

NCT ID: NCT02593175

Vectibix, Paraplatin & Taxol Before Surgery For Early Stage Triple Negative Breast Cancer

Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy Scientific Title

Purpose
To see if giving three types of cancer drugs at the same time before surgery will shrink triple negative tumors.
Who is this for?
Women with stage I, stage II, or stage II triple-negative (ER-, PR-,HER2-) breast cancer but have not yet had surgery. You must also have a type of tumor that is not likely to get smaller with the standard type of chemotherapy usually given before surgery.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following over 3 months followed by surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Panitumumab (Vectibix®), by IV, weekly (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vectibix®, Paraplatin, and Taxol are three different types of cancer drugs. </li> <li class="seamTextUnorderedListItem">Panitumumab (Vectibix®) is a targeted therapy used to treat certain types of colorectal cancer. </li> <li class="seamTextUnorderedListItem">Its use in breast cancer is considered experimental. Experimental drugs can only be used through a clinical trial. </li> <li class="seamTextUnorderedListItem">Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells only, doing less harm to normal cells. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs that are 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/NCT02593175' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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19

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit a week, for 9 weeks

PHASE: II

NCT ID: NCT04216472

Nab-paclitaxel and Alpelisib for Stage I-III Triple Negative or ER-Low, HER2- Breast Cancer with a PIK3CA or PTEN Mutation

A Phase-2, Two-Cohort Trial of Neoadjuvant Nab-Paclitaxel and Alpelisib in Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations Scientific Title

Purpose
To study the anti-tumor activity and effects (good and bad) of combining the chemotherapy nab-paclitaxel (Abraxane®) with the targeted therapy alpelisib (Piqray®).
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 had an anthracycline-based chemotherapy that did not make their tumor disappear, have not yet had surgery, and whose tumor tests positive for or expresses one of the following: PIK3CA or PTEN.    Full eligibility criteria
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  • <p class="seamTextPara"> Before surgery, you will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, once a week, for 9 weeks</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, for 9 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy routinely used 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®) is approved for use in metastatic HR+, HER2- breast cancer that tests positive for a mutation in the PIK3CA gene. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA, PTEN</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 <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT04216472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/trip_neg' target='_blank'>Breastcancer.org: Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hcp.novartis.com/products/piqray/metastatic-breast-cancer/?site=PIQ-1221443GK100070&source=01030&gclid=Cj0KCQjw09HzBRDrARIsAG60GP8NmxZEpBut51InBn-RSi3suu6WOtcycuwZHt4pRFtkVUYNZBtpxGoaAjQJEALw_wcB&gclsrc=aw.ds' target='_blank'>Novartis Pharmaceuticals Information Page: Piqray® (Alpelisib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/issues/december-25-2018/association-between-pathologic-complete-response-after-neoadjuvant-chemotherapy-and-breast-cancer-outcomes/' target='_blank'>ASCO: Association Between Pathologic Complete Response After Neoadjuvant Chemotherapy and Breast Cancer Outcomes</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertreatmentreviews.com/article/S0305-7372(16)30083-4/fulltext' target='_blank'>Journal Article: Nab-paclitaxel for the Treatment of Triple-negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/full/10.1200/EDBK_175631' target='_blank'>Journal Article: Novel Targeted Agents and Immunotherapy in Breast Cancer</a> </li></ul>
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20

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Visits every 1-3 weeks over 6 months

PHASE: II

NCT ID: NCT02876107

Vectibix and Chemotherapy Before Surgery for Triple Negative Inflammatory Breast Cancer

A Randomized Phase II Study of Neoadjuvant Carboplatin/Paclitaxel (CT) Versus Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen for Newly Diagnosed Primary Triple-Negative Inflammatory Breast Cancer Scientific Title

Purpose
To see if chemotherapy combinations used to treat advanced breast cancer are more effective when given along with a targeted drug. The treatments are given before you have surgery.
Who is this for?
Women who are newly diagnosed with stage III, inflammatory triple negative (ER-, PR-, HER2-) breast cancer.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Chemo with Vectibix for 3 months</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Panitumumab (Vectibix®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Chemo without Vectibix for 3 months</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AC (Adriamycin® and Cytoxan®), by IV, every 3 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">followed by surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The initial chemotherapy combination is carboplatin (Paraplatin®) and paclitaxel (Taxol®). </li> <li class="seamTextUnorderedListItem">It is followed by doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®)--known as AC. </li> <li class="seamTextUnorderedListItem">The targeted drug is panitumumab (Vectibix®).</li> <li class="seamTextUnorderedListItem">Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells only, doing less harm to normal cells. </li> <li class="seamTextUnorderedListItem">Vectibix® is currently used to treat a certain type of metastatic colorectal cancer. </li> <li class="seamTextUnorderedListItem">It is not yet known if Vectibix® will be effective as a treatment for breast cancer.</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02876107' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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21

NEAREST SITE: 1682 miles
University of Arkansas for Medical Sciences
Little Rock,AR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02938442

Vaccine Plus Chemotherapy Before Surgery in Triple Negative Breast Cancer

A Combined Phase II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE ISA 51 VG Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Scientific Title

Purpose
To compare the safety and effects of an investigational vaccine along with chemotherapy to chemotherapy alone when given before surgery (neoadjuvant therapy).
Who is this for?
Women with stage II or III triple negative breast cancer (ER-, PR- and HER2-) who are going to be treated with standard chemotherapy before surgery.    Full eligibility criteria
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  • <p class="seamTextPara"> 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). Treatment will be given before surgery. </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemovax (P10s-PADRE with MONTANIDEâ„¢ ISA 51 VG)</li> <li class="seamTextUnorderedListItem">Standard Chemotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard Chemotherapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The vaccine, P10s-PADRE, is a peptide-based vaccine that is designed to enhance the immune response and potentially attack tumors. </li> <li class="seamTextUnorderedListItem">It is given along with Montanide ISA 51 VG, which is designed to enhance an immune response by stimulating cytotoxic T-lymphocytes.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02938442' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mimotope-p10s-padre-peptide-vaccine' target='_blank'>NCI Drug Dictionary: mimotope-P10s-PADRE peptide vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/montanide-isa-51-vg' target='_blank'>NCI Drug Dictionary: Montanide ISA 51 VG</a> </li></ul>
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22

NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO

VISITS: 1 visit a week for 3 months

PHASE: I-II

NCT ID: NCT04331067

Chemotherapy, Immunotherapy, and Cabiralizumab Before Surgery for Stage II-III Triple Negative Breast Cancer

Phase Ib/II Study to Evaluate Safety and Tolerability of Cabiralizumab in Combination With Nivolumab and Neoadjuvant Chemotherapy in Patients With Localized Triple-negative Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity, safety and side effects of giving nivolumab (Opdivo®) and chemotherapy with or without cabiralizumab.
Who is this for?
People with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet started treatment.    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 randomly assigned to 1 of 2 groups and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">surgery, 1 to 2 months after starting the chemotherapies and immunotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Cabiralizumab, by IV, every 2 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">surgery, 1 to 2 months after starting the chemotherapies and immunotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 tumor biopsies</li> <li class="seamTextUnorderedListItem">2 bone marrow biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapies studies suggest might have more anti-cancer activity than the chemotherapies typically given for early-stage <span class="highlight">triple</span> <span class="highlight">negative</span> breast cancer. </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). </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Cabiralizumab is an experimental therapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04331067' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/chemotherapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Chemotherapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ajmc.com/view/study-shows-paclitaxel-carboplatin-effective-against-triple-negative-breast-cancer' target='_blank'>AJMC: Study Shows Paclitaxel, Carboplatin Effective Against Triple-Negative Breast Cancer</a> </li></ul>
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23

NEAREST SITE: 1816 miles
West Cancer Center
Germantown,TN

VISITS: Weekly visits for 4 months

PHASE: II

NCT ID: NCT03812393

Neratinib and Chemotherapy Before Surgery For Triple Negative or ER-Low, HER2- Breast Cancer

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2) Scientific Title

Purpose
To study the safety and effects (good and bad) of giving the anti-HER2 targeted therapy neratinib (Nerlynx®) along with paclitaxel (Taxol®) and carboplatin (Paraplatin®).
Who is this for?
People with stage I or stage II triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that has abnormal HER2 signals based on the Celcuity CELx HER2 Signal Function (HSF) Test and who have not yet started treatment for your breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Core needle biopsy to test for HER2 activity</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, for 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">followed by:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, for 3 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is a HER2 targeted therapy used to treat early-stage, HER2-positive patients who have already been treated with trastuzumab (Herceptin®). </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapy drugs used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">The Celcuity CELx HER2 Signal Function (HSF) Test examines HER2 activity in the tumor. </li> <li class="seamTextUnorderedListItem">Giving treatment before surgery allows researchers to study the effect the treatment has on 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 <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT03812393' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/nerlynx' target='_blank'>Breastcancer.org: Nerlynx</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/breast-cancer/nab-paclitaxelcarboplatin-should-be-first-option-tnbc' target='_blank'>Cancer Network: Nab-Paclitaxel/Carboplatin Should Be a First Option in TNBC</a> </li></ul>
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24

NEAREST SITE: 1832 miles
Froedtert Hospital & Medical College of Wisconsin
Milwaukee,WI

VISITS: 1 visit a week for 5 months

PHASE: II

NCT ID: NCT04243616

Checkpoint Inhibitor Cemiplimab and Chemotherapy Before Surgery in Women with Stage I-III HER2- Breast Cancer That is PD-1/PD-L1 Positive

Phase II Study of PD-1 Inhibition With Cemiplimab in Locally Advanced Hormone Receptor (HR) Positive HER2 Negative or Triple-Negative Breast Cancer Patients Undergoing Standard Neoadjuvant Chemotherapy Scientific Title

Purpose
To study the anti-cancer activity of combining the immunotherapy cemiplimab (Libtayo®) with chemotherapy when they are given together before surgery (neoadjuvant therapy).
Who is this for?
Women with stage I, stage II, or stage III HER2 negative (HER2-) breast cancer planning to have chemotherapy before surgery (neoadjuvant chemotherapy) whose tumor tests positive for PD-1/PD-L1.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®), by IV, every 3 weeks, for 1.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) (optional; as determined by your doctor), by IV, every 3 weeks, for 3 months</li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) and Cyclophosphamide (Cytoxan®), by IV, every 2 weeks, for 2 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®) 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). </li> <li class="seamTextUnorderedListItem">Cemiplimab has been approved to treat certain types of cancer, but 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/NCT04243616' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.libtayo.com/?utm_source=google&utm_medium=cpc&utm_campaign=BrandedGeneral&utm_content=Cemiplimab&gclid=Cj0KCQjw7sz6BRDYARIsAPHzrNKtR1hl8qa7fjF-zydhegx9TDEoFUKDu-9FaUiBalzV8Xpjl8Xk6C0aArWHEALw_wcB' target='_blank'>Regeneron Pharmaceuticals Drug Information Page: Libtayo® (Cemiplimab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/immune-checkpoint-inhibitor' target='_blank'>NCI Dictionary of Cancer Terms: Checkpoint Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/cancer-topics/breast-cancer/breast-cancer-addition-immunotherapy-standard-neoadjuvant-chemotherapy/' target='_blank'>Cancer Therapy Advisor: Addition of Immunotherapy to Standard Neoadjuvant Chemotherapy Yields Promising Results in HER2-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/learn/treatments-and-research/chemotherapy/common-chemotherapy-regimens/ac-t-doxorubicin-and' target='_blank'>Living Beyond Breast Cancer: AC-T Regimen</a> </li></ul>
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25

NEAREST SITE: 1853 miles
University of Illinois
Chicago,IL

VISITS: Weekly visits for 3 months, then every other week for 2 months

PHASE: II

NCT ID: NCT04083963

Carboplatin & Standard Chemotherapy Before Surgery in Triple Negative or ER-Low, HER2- Breast Cancer

BRE-01: Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel Followed by Doxorubicin and Cyclophosphamide in Triple Negative Breast Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of adding a low dose of the chemotherapy paraplatin (Carboplatin®) to the standard of care neoadjuvant chemotherapy regimen for triple negative tumors.
Who is this for?
Women with early-stage (stage II and some stage IIII) triple negative (ER-, PR- and HER2-) or ER-Low (1%-10% ER) breast cancer who have not yet started cancer treatment and is expected to have breast cancer surgery.    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 treatment before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every other week, for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every other week, for 2 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The standard of care regimen includes these three chemotherapies: paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxan®). </li> <li class="seamTextUnorderedListItem">All of the chemotherapies being used in this study are approved to treat breast cancer.</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 women with <span class="highlight">triple</span> <span class="highlight">negative</span> 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/NCT04083963' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/hematology-oncology/breast-cancer/news/print/hemonc-today/%7B4f8936d7-fa9f-443b-8b46-3b5056efceb4%7D/should-neoadjuvant-carboplatin-be-used-for-triple-negative-breast-cancer' target='_blank'>Healio: Should neoadjuvant carboplatin be used for TNBC?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.516' target='_blank'>ASCo 2019: Results of randomized phase II trial of neoadjuvant carboplatin plus docetaxel or carboplatin plus paclitaxel followed by AC in stage I-III TNBC (NCT02413320).</a> </li></ul>
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26

NEAREST SITE: 1853 miles
University of Illinois
Chicago,IL

VISITS: Number of visits unavailable, for 3 weeks before surgery

PHASE: I

NCT ID: NCT04427293

Targeted Therapy & Immunotherapy Before Surgery for Women with Stage I-II Triple Negative or ER-Low Breast Cancer

BRE-03: Window of Opportunity Trial of Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC) Scientific Title

Purpose
To study the anti-cancer activity and side effects of giving the targeted therapy lenvatinib (Lenvima®) and the immunotherapy pembrolizumab (Keytruda®) before surgery.
Who is this for?
Women with stage I or stage II triple negative (ER-, PR-, HER2-) or HER2 negative (HER2-) and ER-Low (1%-10% ER) breast cancer who have not yet started treatment.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following for three weeks before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily, for 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 time</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a targeted therapy that blocks vascular endothelial growth factor receptor 2 (VEGFR2).</li> <li class="seamTextUnorderedListItem">It is approved for certain types of thyroid, kidney and liver cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (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">Pembrolizumab is approved to treat some advanced <span class="highlight">triple</span> <span class="highlight">negative</span> breast cancers, 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/NCT04427293' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/lenvatinib.aspx' target='_blank'>Chemocare.com: Lenvatinib</a> </li></ul>
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27

NEAREST SITE: 1853 miles
University of Illinois Cancer Center
Chicago,IL

VISITS: At least 5 visits over 1 month

PHASE: II

NCT ID: NCT04891068

Experimental Chemotherapy Before Surgery Plus Standard of Care for Women with High-Risk Stage I-II Breast Cancer

BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer Scientific Title

Purpose
To study the safety, dose, anti-cancer activity, and the effects on the immune system of giving a low dose of an experimental chemotherapy before surgery.
Who is this for?
Women with stage I or stage II breast cancer that is considered high-risk for recurrence. See below for this trial's definition of high-risk.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azacitidine, by injection, daily, for 5 days in a row</li> <li class="seamTextUnorderedListItem">followed by the standard of care for your stage and subtype of breast cancer</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial defines high-risk breast cancer as having a primary tumor greater than 1 cm, and the cancer is:</li> <li class="seamTextUnorderedListItem"><span class="highlight">Triple</span>-<span class="highlight">negative</span> (ER-, PR-, HER2-), or</li> <li class="seamTextUnorderedListItem">Estrogen-receptor positive and either HER2-positive, node-positive, progesterone-receptor <span class="highlight">negative</span>, or has a clinical high expression on the MammaPrint, Oncotype, or Endopredict test. </li> <li class="seamTextUnorderedListItem">Azacitidine is a chemotherapy approved for use in other diseases, but 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/NCT04891068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a607068.html' target='_blank'>MedLinePlus: Azacitidine</a> </li></ul>
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28

NEAREST SITE: 2037 miles
St. Elizabeth Healthcare
Edgewood,KY

VISITS: Visits weekly or every 2 weeks for 6 months

PHASE: II

NCT ID: NCT02957968

Keytruda & Decitabine Then Neoadjuvant Chemotherapy in Advanced HER2 Negative Breast Cancer

T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy Scientific Title

Purpose
To study the safety and effects (good and bad) of giving immunotherapy and an experimental chemotherapy before giving standard of care neoadjuvant chemotherapy.
Who is this for?
People with locally advanced (some stage III) HER2 negative (HER2-) breast cancer.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: <span class="highlight">Triple</span> <span class="highlight">Negative</i></span> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Decitabine and pembrolizumab (Keytruda®), scheduled determined by your doctor</li> <li class="seamTextUnorderedListItem">followed by AC (Adriamycin®/Cytoxan®), by IV, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">followed by paclitaxel and carboplatin, by IV, weekly, for 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 <span class="highlight">negative</span>, hormone positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Decitabine and pembrolizumab (Keytruda®), schedule determined by your doctor</li> <li class="seamTextUnorderedListItem">followed by AC (Adriamycin®/Cytoxan®), by IV, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">followed by paclitaxel, by IV, weekly, for 3 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving therapies before surgery is called neoadjuvant treatment. This can shrink your tumor and allow researchers to study the effects the treatment had on your cancer cells. </li> <li class="seamTextUnorderedListItem">The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of cancer but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Keytruda will be given along with the chemotherapy decitabine (Dacogen®), which is used to treat a certain type of blood cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02957968' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/decitabine' target='_blank'>Cancer Research UK: Decitabine</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=Cj0KCQjw-_j1BRDkARIsAJcfmTFCLLDlVuNOgPVdOcuETY7kLiCJ-6rlJU8KGMwPhBxXJjp_oGSLJ1waAg-0E' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li></ul>
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29

NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY

VISITS: 3 visits a week for 3 months, then every 2 weeks for 2 months

PHASE: I

NCT ID: NCT04081389

Chemokine Modulation and Chemotherapy Before Surgery for Stage I-III Triple Negative Breast Cancer

Phase I Clinical Trial Assessing the Combination of Chemokine Modulation With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of using chemokine modulation therapy--celecoxib (Celebrex®), recombinant interferon alfa-2b, and rintatolimod (Ampligen)--and chemotherapy before surgery (neoadjuvant treatment).
Who is this for?
People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who are scheduled to have surgery.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following for 3 months: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Recombinant interferon alfa-2b, by IV, 3 times a week</li> <li class="seamTextUnorderedListItem">Rintatolimod, by IV, 3 times a week</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) by IV, once a week</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">1 to 3 weeks after your last dose of paclitaxel, you will receive the following for 2 months:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin and cyclophosphamide, by IV, once every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemokines are molecules that help to enhance the immune system. </li> <li class="seamTextUnorderedListItem">Chemokine modulation therapy may make chemotherapy more effective.</li> <li class="seamTextUnorderedListItem">The chemotherapy drugs used in this study are doxorubicin (adriamycin) and cyclophosphamide (Cytoxan). Both are 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/NCT04081389' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/recombinant-interferon-alfa-2b' target='_blank'>NCI A to Z List of Cancer Drugs: Recombinant Interferon Alfa-2b</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/rintatolimod' target='_blank'>NCI Drug Dictionary: Rintatolimod</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/sabcs-2017/dr-coombes-on-intriguing-results-with-celecoxib-in-breast-cancer' target='_blank'>OncLive (Video): Dr. Coombes on Intriguing Results With Celecoxib in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/nccn/treatment-triple-negative-breast-cancer-slowly-moving-forward' target='_blank'>Cancer Network: Treatment for Triple-Negative Breast Cancer Slowly Moving Forward</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2019.00379/full' target='_blank'>Journal Article: Chemokines and Chemokine Receptors, New Targets for Cancer Immunotherapy</a> </li></ul>
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30

NEAREST SITE: 2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia,PA

VISITS: 1 visit a year, for 1 to 5 years

PHASE: NA

NCT ID: NCT02732171

Looking for Disseminated Tumor Cells in Bone Marrow After Breast Cancer Treatment to Guide Decisions About Additional Treatment

PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer (SURMOUNT) Scientific Title

Purpose
To look for, study, and treat disseminated tumor cells (DTCs) in the bone marrow of people with high-risk, early-stage breast cancer.
Who is this for?
People who have completed treatment for stage I, stage II, or stage III breast cancer within the last five years. Additionally, your cancer must be considered high risk for recurrence. For this trial, high risk is defined as node-positive, triple-negative, Oncotype score 25 or higher for ER+, HER2- disease, or the presence of residual disease after neoadjuvant (before surgery) chemotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive a bone marrow aspiration test (bone marrow biopsy), then your bone marrow sample will be tested for disseminated tumor cells.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Studies have found that people who have disseminated tumor cells (DTCs) in their bone marrow are at greater risk of having a breast cancer recurrence than people without DTCs. </li> <li class="seamTextUnorderedListItem">A bone marrow aspiration can be used to look for DTCs.</li> <li class="seamTextUnorderedListItem">If you are found to have DTCs in your bone marrow, you will have an opportunity to enroll in a separate clinical trial that is evaluating the effectiveness of using a therapy that targets DTCs to prevent recurrence.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02732171' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pennmedicine.org/cancer/cancer-research/translating-research-to-practice/breast-cancer-tce/surmount-study' target='_blank'>Penn Medicine: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nlm.nih.gov/medlineplus/ency/article/003658.htm' target='_blank'>MedLinePlus: Bone Marrow Aspiration</a> </li></ul>
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31

NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03542175

Rucaparib & Radiation in Triple Negative Breast Cancer That Did Not Fully Respond to Chemo

A Phase I Study of Rucaparib Administered Concurrently With Postoperative Radiotherapy in Patients With Triple Negative Breast Cancer With an Incomplete Pathologic Response Following Neoadjuvant Chemotherapy Scientific Title

Purpose
To look at the safety and effects of using rucaparib (Rubraca™) during radiation therapy given after breast surgery.
Who is this for?
Women with stage I, stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who have cancer cells remaining in her breast or lymph nodes after surgery.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca™), by mouth, twice a day, for 2.5 months</li> <li class="seamTextUnorderedListItem">Radiation, for 1.5 months (number of sessions not available)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rubraca is a type of targeted therapy called a PARP (poly ADP ribose polymerase) inhibitor. It is approved to treat women with advanced ovarian cancer whose tumors have a BCRA mutation. 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/NCT03542175' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/rucaparib.aspx' target='_blank'>Chemocare: Rucaparib</a> </li></ul>
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32

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

VISITS: 3 visits over 2 months

PHASE: I

NCT ID: NCT02977468

Neoadjuvant Keytruda and Radiation Therapy for Stage I-III, Triple Negative or ER-Low, HER2- 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 how pembrolizumab (Keytruda®) affects cancer cells, the healthy tissue surrounding tumors (the microenvironment), the immune system, and intraoperative radiation therapy.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have not yet 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, 1 or 2 times before surgery</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 its effects. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat certain types of breast cancer. Its use in this trial is considered experimental.</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> <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 women with <span class="highlight">triple</span> <span class="highlight">negative</span> 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/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='https://www.breastcancer.org/treatment/radiation/intraoperative' target='_blank'>Breastcancer.org: Intraoperative Radiation Therapy (IORT)</a> </li></ul>
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33

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

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03165487

Breast Tissue Study in Women 40 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 study the healthy tissue surrounding your tumor to determine if this tissue affects how your cancer cells behave.
Who is this for?
Women with DCIS or stage I or stage II, HER2 negative (HER2-) breast cancer. You must also be 40 or older, 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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  • <p class="seamTextPara"> <i class="seamTextEmphasis">During surgery</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 tissue and blood samples will be collected</li> <li class="seamTextUnorderedListItem">Samples will be collected before and after you receive intraoperative radiotherapy</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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34

NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA

VISITS: At least 1 visit every 2 weeks

PHASE: II

NCT ID: NCT04434040

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

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

Purpose
To study if receiving the immunotherapy atezolizumab (Tecentriq®) in combination with the targeted therapy ipatasertib after receiving neoadjuvant chemotherapy and surgery helps prevent recurrence.
Who is this for?
People who received chemotherapy before surgery for triple negative (ER-, PR-, HER2-) breast cancer and were found to still have tumor cells in a breast or lymph node and have evidence of circulating tumor DNA (cfDNA) in their blood. You must be within 1 year of finishing treatment.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), for 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved for use in women with advanced and metastatic <span class="highlight">triple</span> <span class="highlight">negative</span> breast cancer. Its use in early-stage breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Ipatasertib is a type of targeted therapy called an AKT inhibitor. AKT is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA tests look for evidence of breast cancer cells that have left the tumor and are moving through the bloodstream.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04434040' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pathologic-complete-response' target='_blank'>NCI Dictionary of Cancer Terms: Pathological Complete Response</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/ipatasertib-survival-results-continue-to-impress-in-tnbc' target='_blank'>OncLive: Ipatasertib Survival Results Continue to Impress in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI Cancer Currents Blog: Atezolizumab Approved for Some Patients with Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20191218/circulating-tumor-dna-predicts-recurrence-in-earlystage-triplenegative-breast-cancer' target='_blank'>HemOnc Today: Circulating Tumor DNA Predicts Recurrence in Early-Stage TNBC</a> </li></ul>
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35

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute/Brigham and Women's Hospital
Boston,MA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03945721

Niraparib & Radiation in TNBC That Did Not Fully Respond to Neoadjuvant Chemotherapy

A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Patients With Triple Negative Breast Cancer and an Incomplete Pathologic Response Scientific Title

Purpose
To look at the safety and best dose of niraparib (Zejula®) when it is used along with radiation therapy.
Who is this for?
People with stage I, stage II or stage IIIA triple negative (ER-, PR- and HER2-) breast cancer that did not completely respond to the chemotherapy given before surgery.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Radiation therapy </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact the research site for the treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zejula is a type of targeted therapy called a PARP inhibitor. These drugs kill cancer cells by preventing them from repairing damage to their DNA. </li> <li class="seamTextUnorderedListItem">Zejula is approved to treat ovarian 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/NCT03945721' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/niraparib-zejula' target='_blank'>FDA: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/niraparib.aspx' target='_blank'>Chemocare: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/79/4_Supplement/PD5-02' target='_blank'>Cancer Research Abstract: Durability of clinical benefit with niraparib + pembrolizumab in patients with advanced TNBC beyond BRCA</a> </li></ul>
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36

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: 1 visit a week, for 6 months to 1 year

PHASE: II

NCT ID: NCT04443348

Radiation Therapy, Chemotherapy, and Immunotherapy Before Surgery for Stage II-III HER2 Negative, Node Positive Breast Cancer

P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity, safety, and side effects of giving radiation therapy, immunotherapy, and chemotherapy before surgery, and immunotherapy and chemotherapy after surgery.
Who is this for?
People with stage II or stage III HER2-negative breast cancer with at least 1 positive lymph node.    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 randomly assigned to 1 of 2 groups and receive the following for up to 1 year: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Without radiation therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks, for 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and doxorubicin (Adriamycin®), by IV, every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">followed by surgery</li> <li class="seamTextUnorderedListItem">followed by your doctor's choice of pembrolizumab, by IV, every 6 weeks, for another 5.5 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding capecitabine (Xeloda®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: With radiation therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy, once a day, 3 days in a row</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks, for 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and doxorubicin (Adriamycin®), by IV, every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">followed by surgery</li> <li class="seamTextUnorderedListItem">followed by your doctor's choice of pembrolizumab, by IV, every 6 weeks, for another 5.5 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding capecitabine (Xeloda®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, it gets the immune system to go after cancer cells. It is approved to treat many types of cancers, including some types of breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), cyclophosphamide (Cytoxan®), and doxorubicin (Adriamycin®) are chemotherapies commonly used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and capecitabine (Xeloda®) are chemotherapies commonly used to treat <span class="highlight">triple</span>-<span class="highlight">negative</span> (ER-, PR-, HER2-) breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04443348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/keytruda-plus-chemo-before-sx-for-early-tnbc' target='_blank'>Breastcancer.org: Adding Keytruda to Chemotherapy Before Surgery for Early-Stage, Triple-Negative Breast Cancer Improves Response to Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20191205/pembrolizumab-plus-radiotherapy-safe-active-in-metastatic-triplenegative-breast-cancer' target='_blank'>Healio: Pembrolizumab Plus Radiotherapy Safe, Active in Metastatic Triple-Negative Breast Cancer</a> </li></ul>
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