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(Last updated: October 28, 2020)

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT02927249

Aspirin to Prevent Recurrence in Stage II-III, HER2 Negative, Node-Positive Breast Cancer

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial Scientific Title

Purpose

To study if taking aspirin daily for five years reduces recurrences (cancer coming back).

Who is this for?

People who have completed treatment for stage II or stage III, HER2 negative (HER2-) breast cancer who are within one year of their diagnosis. You must also have had cancer cells found in your lymph nodes or have high-risk, node-negative breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aspirin, by mouth, daily, up to 5 years </li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, up to 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aspirin is widely used because of its ability to reduce pain, fever, inflammation, and blood clotting.</li> <li class="seamTextUnorderedListItem">For this trial, high-risk, node-negative breast cancer is defined as triple negative (ER-, PR-, HER2-) with a breast tumor greater than 2 cm.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02927249' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://jcto.weill.cornell.edu/open_clinical_trials/a011502-aspirin-in-preventing-recurrence-of-cancer-in-patients-with-node-positive-her2-negative-stage-ii-iii-breast-cancer-after-chemotherapy-surgery-andor-radiation-therapy' target='_blank'>Weill Cornell Medicine: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/aspirin-and-secondary-cancer' target='_blank'>Cancer Research UK: Can Aspirin Stop My Cancer Spreading?</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2019/11/should-i-take-aspirin-to-prevent-cancer/' target='_blank'>Dana-Farber Cancer Institute: Should I Take Aspirin to Prevent Cancer?</a> </li></ul>

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 Neoadjuvant Chemo and Surgery for Basal-Like Triple-Negative 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 drug after surgery reduces the risk of recurrence.

Who is this for?

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

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Participants will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) or Carboplatin (Paraplatin®) by IV, every 3 weeks</li> </ul> Group 2: No intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor. </li> <li class="seamTextUnorderedListItem">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 chemotherapy drugs that laboratory studies suggest may be effective against basal-like triple-negative breast cancer.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02445391' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.medscape.com/viewarticle/736911_4' target='_blank'>MedScape: Basal-like breast cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.ca/en/cancer-information/cancer-type/breast/breast-cancer/cancerous-tumours/triple-negative-breast-cancer/?region=on' target='_blank'>Canadian Cancer Society: Triple-negative and basal-like breast cancers</a> </li></ul>

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

VISITS: Weekly visits for 5 months

PHASE: III

NCT ID: NCT02488967

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 1 visit every 3 weeks, for 1 year

PHASE: III

NCT ID: NCT02954874

Keytruda After Neoadjuvant Chemo & Surgery for Stage I-III Triple-Negative Breast Cancer

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy Scientific Title

Purpose

To study the effects (good and bad) of giving pembrolizumab (Keytruda®) after chemotherapy and surgery.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-,PR-,HER2-) breast cancer. You must still have had part of the tumor in your breast and/or been told cancer cells were found in your lymph nodes after you received neoadjuvant (before surgery) chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Observation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No treatment, but monitored during the first year</li> <li class="seamTextUnorderedListItem">Examined every 3 months for 1 year, every 6 months for 4 years, and annually for 5 years</li> </ul> Group 2: Keytruda <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, over 1 year</li> </ul> Follow up <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Up to 10 years</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. </li> <li class="seamTextUnorderedListItem">It is approved to treat many types of cancers, including some types of breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02954874' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li></ul>

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

VISITS: 21 visits over 2 years

PHASE: III

NCT ID: NCT03562637

An Immunotherapy Combination for Stage I-III Triple Negative Breast 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-) breast cancer who have completed chemotherapy. You must have had cancer cells remaining if you had neoadjuvant (before surgery) chemotherapy or had 4 or more positive lymph nodes at the time of surgery if you had adjuvant (after surgery) chemotherapy. Full eligibility criteria

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

NEAREST SITE: 25 miles
John Muir Health Clinical Research Center
Concord,CA

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

PHASE: III

NCT ID: NCT03498716

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 326 miles
Kaiser Permanente-Woodland Hills
Woodland Hills,CA

VISITS: Visits every 3 weeks

PHASE: III

NCT ID: NCT03281954

Chemotherapy before Surgery with Atezolizumab for Triple Negative Breast Cancer

A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo Scientific Title

Purpose

To compare the safety and effects (good and bad) of using an immunotherapy along with the standard of care chemotherapy to using a placebo along with the standard of care chemotherapy before and after surgery.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer. You must not have had any prior anti-cancer therapy including surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of care plus Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy plus atezolizumab (Tecentriq®) by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">followed by a different chemotherapy regimen plus atezolizumab (Tecentriq®), by IV, every 2 or 3 weeks, for 2 to 3 months</li> <li class="seamTextUnorderedListItem">followed by surgery (lumpectomy or mastectomy)</li> <li class="seamTextUnorderedListItem">followed by atezolizumab (Tecentriq®), by IV, every 3 weeks for up to 1 year </li> </ul> Group 2: Standard of care plus Placebo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy plus placebo by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">followed by a different chemotherapy regimen plus placebo, by IV, every 2 or 3 weeks, for 2 to 3 months</li> <li class="seamTextUnorderedListItem">followed by surgery (lumpectomy or mastectomy)</li> <li class="seamTextUnorderedListItem">followed by placebo, by IV, every 3 weeks for up to 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy used in this study is atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Atezolizumab is a PD-L1 inhibitor approved to treat some triple negative (ER-, PR-, HER2-) metastatic (stage IV) breast cancers and certain types of bladder and lung cancer. </li> <li class="seamTextUnorderedListItem">It works by blocking the PD-L1 (programmed death-ligand 1) protein.</li> <li class="seamTextUnorderedListItem">The standard of care chemotherapy drugs used in this study are paclitaxel (Taxol®) and carboplatin (Paraplatin®) followed by doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) or epirubicin (Ellence®) and cyclophosphamide.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03281954' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/understanding-triple-negative-breast-cancer/' target='_blank'>Triple Negative Breast Cancer Foundation: Understanding TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech: Tecentriq</a> </li></ul>

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

VISITS: 2 visits, over 3 weeks

PHASE: I-II

NCT ID: NCT03366844

Pembrolizumab and Radiation before Surgery for Stage II-III Triple Negative and Select HR+, HER2- Breast Cancer

Pilot Study of the Preoperative Combination of Pembrolizumab and Radiation Therapy in Patients With Operable Breast Cancer Scientific Title

Purpose

To look at the effects (good and bad) of giving pembrolizumab (Keytruda®) and radiation therapy before surgery.

Who is this for?

Women with stage II or stage III, estrogen receptor positive (ER+), HER2 negative (HER2-) or triple negative (ER-, PR-, HER2-) breast cancer planning to receive breast-conserving surgery (lumpectomy). Full eligibility criteria

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice over 3 weeks </li> <li class="seamTextUnorderedListItem">Radiation therapy, once, along with second dose of Pembrolizumab</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving treatment before surgery is called neoadjuvant therapy. It gives researchers the ability to study the effect the treatment has on the cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. By blocking PD-1, it helps the immune system see and kill cancer cells. Keytruda is approved to treat certain types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Radiation is commonly used to treat women with breast cancer who have had a lumpectomy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03366844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/merck-s-keytruda-hits-another-endpoint-this-time-in-triple-negative-breast-cancer/' target='_blank'>Biospace: Keytruda in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/blog/2019-02/immunotherapy-breast-cancer-treatment-it-option' target='_blank'>Cancer.net: Immunotherapy for Breast Cancer Treatment: Is It an Option?</a> </li></ul>

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 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-) breast cancer who had taxane-based chemotherapy before surgery and still have some tumor remaining. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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> Group 2: Standard of Care <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></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>

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-) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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> Group 2 <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 people with triple negative as well as ER-Low, HER2 negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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>

NEAREST SITE: 650 miles
Mayo Clinic Arizona
Phoenix,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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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, for 2 to 3 weeks</li> </ul> Additional procedures <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 people with triple negative 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>

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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You will be randomly assigned to 1 of 4 groups: Group 1 <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> Group 2 <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> Group 3 <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> Group 4 <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 triple negative (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>

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 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-) breast cancer who are scheduled to have breast cancer surgery. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®), by mouth, twice daily, for 3 weeks before surgery</li> </ul> Additional procedures <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></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>

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 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-) breast cancer. Full eligibility criteria

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This is a data collection (registry) study. You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA 1 and BRCA 2 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>

NEAREST SITE: 1298 miles
CHI Health Saint Francis
Grand Island,NE

VISITS: 6 visits over 3 months, plus surgery

PHASE: II

NCT ID: NCT01750073

Two Chemotherapies & Herceptin Before Surgery for Women With Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) of giving paclitaxel (Taxol®) with cyclophosphamide (Cytoxan®).

Who is this for?

Women with stage I, stage II, or stage III breast cancer. Full eligibility criteria

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You will receive the following: Before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and Cyclophosphamide (Cytoxan®) by IV every 2 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) by IV, every 2 weeks, for 12 weeks (only if your tumor is HER2 positive)</li> </ul> 4 to 8 weeks later, mastectomy or breast conserving surgery. After surgery: If your tumor is HER2 positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard radiation therapy</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, up to 9 months</li> </ul> If your tumor is hormone positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">anti-hormone therapy</li> </ul> If your tumor is triple negative and stage I <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard radiation therapy</li> </ul> If your tumor is triple negative and stage II-III <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin hydrochloride (Adriamycin®), by IV, every 2 weeks, up to 2 months</li> <li class="seamTextUnorderedListItem">Standard radiation therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery.</li> <li class="seamTextUnorderedListItem">It also allows researchers to study how tumors respond to certain drugs. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapies that are routinely used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination of paclitaxel, cyclophosphamide, and trastuzumab.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01750073' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/herceptin-benefits-same-during-or-after-chemo' target='_blank'>Breastcancer.org: Herceptin Before Surgery Offers Same Long-Term Benefits When Given At Same Time or After Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/Neoadjuvant.html' target='_blank'>Susan G. Komen: Neoadjuvant Therapies</a> </li></ul>

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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You will receive the following: <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> All medications are given once every 3 weeks, for 4.5 months
<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 triple negative 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>

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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You will receive the following: <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-negative 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>

NEAREST SITE: 1562 miles
Highlands Oncology Group
Fayetteville,AR

VISITS: Number of visits unavailable

PHASE: 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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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. Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemovax (P10s-PADRE with MONTANIDEâ„¢ ISA 51 VG)</li> <li class="seamTextUnorderedListItem">Standard Chemotherapy</li> </ul> Group 2: <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>

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 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 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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You will receive the following: <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></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></ul>

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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You will receive the following before surgery: <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 triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Androgen receptors (AR) are found on many triple-negative 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>

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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You will receive the following over 3 months followed by surgery: <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>

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

VISITS: Visits weekly

PHASE: II

NCT ID: NCT02530489

Atezolizumab & Abraxane for Triple Negative Stage I-III Breast Tumors

Triple-Negative First-Line Study: Neoadjuvant Trial of Nab-Paclitaxel and MPDL3280A, a Pdl-1 Inhibitor in Patients With Triple Negative Breast Cancer Scientific Title

Purpose

To look at the safety and effects (good and bad) of using atezolizumab (Tecentriq®) and nab-paclitaxel (Abraxane®) before surgery and then using atezolizumab after surgery.

Who is this for?

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

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All participants will receive the following: Before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">MPDL3280A (atezolizumab), by IV, every 3 weeks for 3 months</li> </ul> After surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MPDL3280A, by IV, every 3 weeks for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is an immunotherapy drug that stimulates the body's immune system to go after cancer cells. It works by blocking a protein called programmed cell death ligand-1 (PD-L1) that normally keeps the body's immune system from attacking and destroying tumor cells. </li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug routinely used to treat advanced breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02530489' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: Weekly visits for 3 months

PHASE: II

NCT ID: NCT02456857

Liposomal Doxorubicin, Bevacizumab and Temsirolimus For Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

Women's Triple-Negative First-Line Study: A Phase II Trial of Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy Scientific Title

Purpose

To study the effect that the DAT regimen has when it is given before surgery.

Who is this for?

Women with triple negative (ER-, PR-, HER2-) breast cancer who have stopped a neoadjuvant chemotherapy because the cancer progressed or they experienced too many side effects to continue. Full eligibility criteria

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All participants will receive the following treatment before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DAT (Bevacizumab, Liposomal Doxorubicin and Temsirolimus), by IV for 6 hours, once every 3 weeks, for 3 months</li> <li class="seamTextUnorderedListItem">Temsirolimus (Torisel®) alone, by IV for 90 minutes, weekly following each DAT treatment</li> </ul> followed by surgery
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The experimental drug regimen DAT, consists of liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and temsirolimus (Torisel®). </li> <li class="seamTextUnorderedListItem">Doxil is a chemotherapy drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Avastin works by keeping the cancer from making the blood vessels it needs to grow. It currently is not approved as a breast cancer treatment. </li> <li class="seamTextUnorderedListItem">Torisel is an mTOR inhibitor. It works by blocking a protein called mTOR that helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">Treatment given before surgery--called neoadjuvant therapy---allows researchers to see the effect that the treatment has on the tumor.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02456857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02456857?term=NCT02456857&rank=1' target='_blank'>ClincialTrials.gov trial information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/cancer-drugs/temsirolimus' target='_blank'>CancerResearchUK: Temsirolimus</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/cancer-drugs/liposomal-doxorubicin' target='_blank'>CancerResearchUK: Liposomal doxorubicin</a> </li></ul>

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 TNBC 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-) breast cancer that did not fully respond to neoadjuvant chemotherapy (treatment given before surgery). Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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> Group 2: Standard treatment <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 triple negative 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></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>

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 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-) 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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Before surgery, you will receive the following: <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 drug 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></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>

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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You will be randomly assigned to 1 of 2 groups and will receive the following: Group 1: Chemo with Vectibix for 3 months <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> Group 2: Chemo without Vectibix for 3 months <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> Followed by: <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>

NEAREST SITE: 1643 miles
The Methodist Hospital System
Houston,TX

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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You will be assigned to 1 of 2 groups: Group 1: Triple Negative <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> Group 2: HER2 negative, hormone positive <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 drug 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>

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

VISITS: Number of visits unavailable, over 5 months

PHASE: II

NCT ID: NCT02124902

Taxotere and Paraplatin Before Surgery in Women with Stage II-III, Triple Negative or ER-, HER2- Breast Cancer

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery Scientific Title

Purpose

To study the effects (good and bad) that docetaxel (Taxotere®) and carboplatin (Paraplatin®) have on breast cancer cells.

Who is this for?

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

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You will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative (ER-, PR-, HER2-) and estrogen receptor negative, progesterone receptor positive, HER2 negative (ER-, PR+, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells.</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02124902' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/Neoadjuvant.html' target='_blank'>Susan G. Komen: Neoadjuvant Thearpy</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/druglist/taxotere' target='_blank'>Breastcancer.org: Docetaxel</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page8' target='_blank'>NCI: Triple-Negative Breast Cancer</a> </li></ul>

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

VISITS: 7 visits over 6 months

PHASE: I

NCT ID: NCT02427581

Breast Cancer Vaccine for Triple Negative Breast Cancer Following Chemo Before Surgery

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Scientific Title

Purpose

To study the best dose and effects (good and bad) of using a personalized synthetic long peptide vaccine.

Who is this for?

Women with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who received neoadjuvant (before surgery) chemotherapy and still had cancer cells in their breast during surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized synthetic long peptide breast cancer vaccine, 4 injections in the first 10 days, then 3 additional injections over 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A peptide is a naturally occurring biological molecule made up of amino acids. </li> <li class="seamTextUnorderedListItem">Researchers have developed a way to create a personalized synthetic long peptide vaccine that can generate an immune response to breast cancer cells by targeting mutations specific to a person's tumor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02427581' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2015-01050&r=1' target='_blank'>NCI Study Website: Personalized Vaccine Therapy in Treating Patients with Triple-Negative Breast Cancer</a> </li></ul>

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

VISITS: Visits 7 times over 1 year

PHASE: I

NCT ID: NCT03199040

Vaccine & Immunotherapy After Standard Care for Stage II-III Triple Negative Breast Cancer

A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy Scientific Title

Purpose

To study the effects (good and bad) of a personalized vaccine given alone or with an immunotherapy drug.

Who is this for?

Women newly diagnosed with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who have already received standard of care therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">followed by personalized vaccine, by injection, 6 times over 4 months (at least 3 weeks between each injection)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by injection, monthly, starting at 3 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">followed by personalized vaccine, by injection, 6 times over 4 months (at least 3 weeks between each injection )</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The personalized vaccine used in this study is a neoantigen DNA vaccine. </li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is an immunotherapy drug that works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of lung cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03199040' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/d41586-017-08706-3' target='_blank'>Nature: Neoantiven Vaccines</a> </li></ul>

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 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-) 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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You will receive the following before surgery: <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> followed by: <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></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>

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 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 drug 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-) breast cancer who have not yet started cancer treatment and is expected to have breast cancer surgery. Full eligibility criteria

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You will receive the following treatment before surgery: <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 chemotherapy drugs: paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxan®). </li> <li class="seamTextUnorderedListItem">All of the chemotherapy drugs being used in this study are approved 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/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>

NEAREST SITE: 1857 miles
University of Chicago
Chicago,IL

VISITS: Visits every 3 weeks, for 6 months

PHASE: II

NCT ID: NCT03487666

Opdivo plus Xeloda After Surgery for Triple Negative Breast Cancer

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy Scientific Title

Purpose

To compare the effects (good and bad) of using two drugs alone or together after surgery.

Who is this for?

People with triple negative (ER-, PR-, and HER2-), DCIS, LCIS, or early stage (stage I, stage II or stage III) breast cancer that was treated with chemotherapy before surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks, for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, for 6 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs being used in this study are nivolumab (Opdivo®) and capecitabine (Xeloda®).</li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Xeloda is a chemotherapy drug 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/NCT03487666' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li></ul>

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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You will receive the following for 3 months: <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> 1 to 3 weeks after your last dose of paclitaxel, you will receive the following for 2 months: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin and cyclophosphamide, by IV, once every 2 weeks</li> </ul> Additional procedures <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>

NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03564782

PVSRIPO Vaccine in Stage II, III and IV Triple Negative Breast Cancer

Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Triple Negative Breast Cancer Scientific Title

Purpose

To look at the safety, effects (good and bad) and best dose of an experimental immunotherapy called PVSRIPO.

Who is this for?

Women with stage II-III triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options or who has metastatic (stage IV) TNBC with a local recurrence on the chest wall. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO, by injection, one time </li> <li class="seamTextUnorderedListItem">Surgery as planned</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO is a vaccine made out of a modified poliovirus. </li> <li class="seamTextUnorderedListItem">The vaccine uses the virus to get the immune system to kill cancer cells. </li> <li class="seamTextUnorderedListItem">You can not get polio from the vaccine.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03564782' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-oncolytic-poliovirus-pvs-ripo' target='_blank'>Cancer.gov: Recombinant oncolytic poliovirus PVS-RIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.istarioncology.com/our-science/pvs-ripo/' target='_blank'>Sponsor site: PVSRIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e12641' target='_blank'>Journal of Clinical Oncology: Recombinant oncolytic poliovirus combined with checkpoint blockade for breast cancer therapy</a> </li></ul>

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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You will receive the following: <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>

NEAREST SITE: 2569 miles
Columbia University 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 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-) breast cancer who have not yet received any treatment for their cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 or 2 times before surgery</li> </ul> Followed by <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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02977468' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/20659' target='_blank'>ASCO Post: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation/types/intraoperative' target='_blank'>Breastcancer.org: Intraoperative Radiation Therapy (IORT)</a> </li></ul>

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

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03165487

Breast Tissue Study in Women 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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During surgery <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>

NEAREST SITE: 2685 miles
Massachusetts General Hospital at Newton-Wellesley Hospital
Newton,MA

VISITS: 1 visit every week for 3 months

PHASE: II

NCT ID: NCT04230109

Sacituzumab Govitecan Before Surgery for Stage I-III Triple Negative Breast Cancer

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR) Scientific Title

Purpose

To study the anti-cancer activity and safety of the targeted therapy sacituzumab govitecan (Trodelvy) in early-stage triple negative breast cancer.

Who is this for?

People with stage I, 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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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic (stage IV) triple negative breast cancer. Its use in people with early stage triple negative breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan targets TROP2 proteins and delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04230109' 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.org/cancer/breast-cancer/treatment/treatment-of-triple-negative.html' target='_blank'>American Cancer Society: Treatment of Triple Negative Breast Cancer</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.trodelvy.com/patient/home' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer' target='_blank'>FDA Drug Approvals and Databases: Sacituzumab Govitecan-hziy for Metastatic TNBC</a> </li></ul>

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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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Radiation therapy </li> </ul> Please contact the research site for the treatment schedule
<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>

No Travel Required

VISITS: Saliva sample and questionnaire by mail

PHASE: NA

NCT ID: NCT01251900

BRCA Gene Mutations in Latinas and Hispanic Women with Breast Cancer

BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects Scientific Title

Purpose

To study how common BRCA1 and BRCA2 mutations are among Hispanic women and Latinas with breast cancer.

Who is this for?

Women with stage I, stage II, stage III or metastatic (stage IV) breast cancer who are Hispanic or Latina. Full eligibility criteria

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All participants will: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide a saliva sample </li> <li class="seamTextUnorderedListItem">Complete a questionnaire </li> <li class="seamTextUnorderedListItem">Provide a copy of pathology report</li> </ul> No study visits are required. The consent process can be done by phone (in English or Spanish) and the questionnaire and saliva collections completed by U.S. mail.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some women who have triple negative (ER-, PR-, HER2-) breast cancer also have a BRCA 1 or BRCA 2 genetic mutation.</li> <li class="seamTextUnorderedListItem">The number of Hispanic women and Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is unknown. </li> <li class="seamTextUnorderedListItem">Learning more about BRCA1/2 mutation rates among Latinas and Hispanic women will help researchers provide better treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01251900' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA' target='_blank'>NCI: BRCA Mutations</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Gene Mutations</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/TripleNegativeBreastCancer.html' target='_blank'>Susan G. Komen: Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/espanol/tipos/seno' target='_blank'>NCI: Cá¡ncer de seno</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/espanol/cancer/cancerdeseno/' target='_blank'>American Cancer Society: Cá¡ncer de seno</a> </li></ul>