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(Last updated: December 06, 2019)

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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 Node-Positive HER2- Stage II-III 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 whether taking aspirin daily for five years can reduce the risk of a breast cancer recurrence.

Who is this for?

Women and men who have completed treatment for stage II or stage II HER2 negative breast cancer. You must also have had cancer cells found in your lymph nodes. Full eligibility criteria

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You will be randomly assigned to 1 of 2 group: 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> </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'>Trial website</a> </li></ul>

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

VISITS: 3 or 5 visits over 5 years

PHASE: III

NCT ID: NCT03233191

Digital Tomosynthesis Mammography for Breast Cancer Screening

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) Scientific Title

Purpose

To study whether digital tomosynthesis (3D) mammography or digital (2D) mammography is better at finding early-stage tumors and improving breast cancer survival.

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard digital (2D) mammogram, once a year for 5 years if pre-menopausal; every other year for 5 years if post-menopausal</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Digital tomosynthesis (3D) mammogram, once a year for 5 years if pre-menopausal; every other year for 5 years if post-menopausal</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Digital tomosynthesis (3D) mammography is approved by the FDA but is not considered the standard of care for breast cancer screening. </li> <li class="seamTextUnorderedListItem">Digital (2D) mammography is the standard of care for breast cancer screening.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03233191' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/dig_tomosynth' target='_blank'>Breastcancer.org: Digital Tomosynthesis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/breast_center/treatments_services/breast_cancer_screening/digital_mammography/index.html' target='_blank'>Johns Hopkins Medicine: Digital Mammography</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/tmist-breast-cancer-screening' target='_blank'>NCI: TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches</a> </li></ul>

NEAREST SITE: 2 miles
UCLA Pasadena Health Care Hematology Oncology
Pasadena,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03701334

Ribociclib With Hormone Therapy For HR Positive, HER2 Negative Early Breast Cancer

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE) Scientific Title

Purpose

To compare the effectiveness and side effects of ribociclib (Kisqali®) and hormonal therapy to hormonal therapy alone.

Who is this for?

Women and men with estrogen receptor (ER) positive, HER2 negative DCIS or stage II or III breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Hormonal therapy, by mouth, daily (determined by your physician)</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormonal therapy, by mouth, daily (determined by your physician)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Kisqali®) is a type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. </li> <li class="seamTextUnorderedListItem">It blocks two enzymes, CDK4 and CDK6, that help cancer cells grow. </li> <li class="seamTextUnorderedListItem">It is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with HR positive, HER2 negative advanced or metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Its use in early-stage 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/NCT03701334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm546438.htm' target='_blank'>FDA Approval: Ribociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hcp.novartis.com/products/kisqali/metastatic-breast-cancer/' target='_blank'>Novartis: Kisqali</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/targeted-therapy/ribociclib-kisqali#How%20is%20ribociclib%20given' target='_blank'>BreastCancerCareUK: Ribociclib (Kisqali)</a> </li></ul>

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

VISITS: Visits weekly

PHASE: I

NCT ID: NCT02684032

Gedatolisib with Ibrance and Femara or Faslodex in ER+ HER2- Metastatic Breast Cancer

Phase 1b Study To Assess The Safety, Tolerability, And Clinical Activity Of Gedatolisib In Combination With Palbociclib And Either Letrozole Or Fulvestrant In Women With Metastatic Or Locally Advanced/Recurrent Breast Cancer (MBC) Scientific Title

Purpose

To determine the best dose of gedatolisib, an mTOR inhibitor, given in combination with either Femara or Faslodex.

Who is this for?

Women who have estrogen receptor positive and HER2 negative metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are studying new treatment combinations for metastatic breast cancer. Palbociclib (Ibrance®) is a targeted drug that is used to treat metastatic breast cancer. It is given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02684032' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02684032?term=NCT02684032&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li></ul>

NEAREST SITE: 3 miles
Novartis Investigative Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02734615

LSZ102 Alone or With Ribociclib or Alpelisib in ER+ Advanced Breast Cancer

A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy Scientific Title

Purpose

To determine the best dose of LSZ102, an investigational therapy for ER+ breast cancer, given alone or in combination with a targeted drug.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer that is estrogen receptor positive. You must have been previously treated and your cancer must have progressed on hormone therapy. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LSZ102, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LSZ102, by mouth</li> <li class="seamTextUnorderedListItem">Ribociclib (LEE011), by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LSZ102, by mouth</li> <li class="seamTextUnorderedListItem">Alpelisib (BYL719), by mouth, daily</li> </ul> LSZ102 schedule will be determined by the physician.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing new drugs to treat hormone-sensitive metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">LSZ102 is a new drug that works by destroying the estrogen receptor. </li> <li class="seamTextUnorderedListItem">The two targeted drugs are called ribociclib and alpelisib.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02734615' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02734615?term=NCT02734615&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02498613

Cediranib + Lynparza for Metastatic Triple Negative Breast Cancer (and Other Solid Tumors)

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors Scientific Title

Purpose

To see how well metastatic breast cancer (and other solid tumors) can be treated with two drugs: Olaparib (Lynparza®), a PARP inhibitor, and Cediranib, a targeted therapy that inhibits the growth of blood vessels.

Who is this for?

Women and men with stage III or metastatic (stage IV) triple negative breast cancer. You must have received one prior therapy for your cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">Cediranib is a type of drug called an angiogenesis inhibitor. </li> <li class="seamTextUnorderedListItem">Giving cediranib with Lynparza may make the Lynparza more effective.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02498613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/891245' target='_blank'>Medscape: Olaparib</a> </li></ul>

NEAREST SITE: 3 miles
Sutter Cancer Research Consortium
San Francisco,CA

VISITS: Coincides with targeted therapy

PHASE: II

NCT ID: NCT02693535

Treating Advanced Cancer By Choosing Targeted Therapy Based on Tumor's Genetic Makeup

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using a tumor's genetic alterations to select an FDA-approved targeted therapy for treatment.

Who is this for?

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

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Participants will receive an FDA-approved targeted therapy that is chosen based on the tumor's genetic makeup.
The targeted therapy each patient receives will be selected based on their tumor's specific genetic profile.
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02693535?term=tapur&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>About the TAPUR Study</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive video: TAPUR</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02655822

Immunotherapy for Metastatic Triple Negative Breast (and Other) Cancers

A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers Scientific Title

Purpose

To look at the safety and effects (good and bad) of different scheduling cycles for CPI-444 as well as the safety and effect of giving CPI-444 along with MPDL3280A.

Who is this for?

Women and men with metastatic (stage IV) triple negative breast cancer. You must have at least 1 but not more than 5 prior systemic therapies for metastatic disease. Full eligibility criteria

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Participants will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-444, by mouth, twice daily, 2 weeks on, 2 weeks off</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-444, by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-444, by mouth, once daily, 2 weeks on, 2 weeks off</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-444, by mouth</li> <li class="seamTextUnorderedListItem">Atezolizumab (MPDL3280A), by IV</li></ul>
Many tumors produce a lot of adenosine, a molecule that interacts with the immune system and keeps immune cells from going after cancer cells. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-444 is a new type of immunotherapy drug. It keeps adenosine from being able to tell the immune cells not to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Atezolizumab (MPDL3280A) is another new immunotherapy drug. It blocks a protein called programmed death ligand-1 (PD-L1). Blocking this protein allows the body's immune system to go after cancer cells.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02655822' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02655822' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.corvuspharma.com/technology/adenosine-cancer-axis/' target='_blank'>Corvus Pharma: CPI-444</a> </li></ul>

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

VISITS: Varies based on assigned treatment

PHASE: II

NCT ID: NCT02465060

NCI-MATCH: Choosing the Best Drug for Metastatic Breast (and Other) Cancer

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

Purpose

To see how well treatment that is chosen based on results from genetic testing works in patients with solid tumors or lymphomas.

Who is this for?

Women and men with metastatic (advanced) breast cancer for whom available therapy is no longer an option. Full eligibility criteria

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You will undergo the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Your tumor sample will be tested to identify genetic mutations</li> <li class="seamTextUnorderedListItem">You will be assigned to 1 of 24 treatment groups based on your tumor test results</li> <li class="seamTextUnorderedListItem">(Optional) End-of-treatment biopsy and collection of blood samples for research purposes</li> </ul> You may repeat this process if you experience disease progression or if you could not tolerate the assigned treatment.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cancer cells grow because they have genetic errors inside them. </li> <li class="seamTextUnorderedListItem">Scientists are developing cancer treatments that keep these errors from helping the cancer grow. </li> <li class="seamTextUnorderedListItem">The National Cancer Institute (NCI) started a trial called MATCH (Molecular Analysis for Therapy Choice).</li> <li class="seamTextUnorderedListItem">Your tumor will be tested (<q>genetic testing</q>) to see what genetic mistakes it contains. </li> <li class="seamTextUnorderedListItem">The researchers will then see if there is a cancer drug that is a good match for your tumor's genetic mistakes.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Adavosertib, Afatinib, Binimetinib, Capivasertib, Copanlisib, Crizotinib, Dabrafenib, Dasatinib, Defactinib, Erdafitinib, FGFR Inhibitor AZD4547, Larotrectinib, Nivolumab, Osimertinib, Palbociclib (CDK inhibitor), Pertuzumab (anti-HER2), PI3K-beta Inhibitor GSK2636771, Sapanisertib, Sunitinib Malate, Taselisib, Trametinib, Trastuzumab Emtansine/Kadcyla (antibody-drug conjugate (ADC)), Vismodegib</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02465060' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match' target='_blank'>NCI-Match: Trial website</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/news-events/press-releases/2015/nci-match-qa.pdf' target='_blank'>NCI-MATCH FAQs</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Mount Zion Medical Ctr
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02568267

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

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

Purpose

To evaluate entrectinib (RXDX-101) in individuals with solid tumors that have an NTRK1/2/3, ROS1, or ALK gene rearrangement.

Who is this for?

Women and men with breast cancer who have a tumor that tests positive for a NTRK1/2/3, ROS1 or ALK rearrangement. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (RXDX-101) by mouth</li></ul>
Basket studies enroll patients based on the kind of mutations found in their tumors, rather than the type of cancer they have.
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02568267' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02568267?term=NCT02568267&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://breasthealthandhealing.org/basket-studies-the-next-frontier-in-breast-cancer-research/' target='_blank'>Breast Health and Healing Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='http://ignyta.com/wp-content/uploads/2015/10/ESMO-2015-entrectinib_F.pdf' target='_blank'>Ignyta presentation: RXDX-101</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?

Women and men 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
University of California San Francisco (UCSF)
San Francisco,CA

VISITS: Weekly visits for 4 months

PHASE: II

NCT ID: NCT01042379

Personalized Treatment Before Surgery: The I-SPY 2 Trial

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

Purpose

To learn more quickly which types of tumors respond best to which investigational drugs and whether any of these investigational drugs have the potential to be new targeted therapies

Who is this for?

Women with stage II or stage III breast cancer and one of the following three types of tumors: MammaPrint High and any estrogen receptor or HER status; MammaPrint Low, estrogen receptor negative (ER-), and any HER2 status; or MammaPrint Low, estrogen receptor positive, and HER2 positive. Full eligibility criteria

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All participants will receive the following treatment before surgery: Standard Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) by IV, weekly, for 1 month</li> </ul> Note: Participants with HER2-positive cancer may also receive trastuzumab (Herceptin®). Investigational Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">80% of participants will receive an investigational drug along with standard chemotherapy. The drug will be chosen based on your tumor characteristics.</li> <li class="seamTextUnorderedListItem">This study has an <q>adaptive design.</q> This means that new investigational drugs will be added during the study and that those that are not shown to be more effective than standard therapy alone will be dropped.</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy--giving patients treatment that is tailored to their specific tumor type-- is an active area of breast cancer research. </li> <li class="seamTextUnorderedListItem">Chemotherapy given before surgery is referred to as neoadjuvant treatment. </li> <li class="seamTextUnorderedListItem">By measuring the size of the tumor before and after neoadjuvant treatment, doctors can determine whether the tumor is responding to the drugs being used. </li> <li class="seamTextUnorderedListItem">The goal of this trial is to use the neoadjuvant setting to investigate whether there are investigational drugs that can be added to a standard chemotherapy regimen that make it more effective than the standard chemotherapy regimen alone. </li> <li class="seamTextUnorderedListItem">The trial is also investigating whether there are molecular tests that can be used on tumor tissue that can determine which types of tumors should be treated with which investigational drugs. </li> <li class="seamTextUnorderedListItem">The information the researchers gain from each participant will be used to help decide which treatments should be used for women who join the trial at a later date.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://ispy2.org/' target='_blank'>I-SPY 2 Website</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.coe.ucsf.edu/coe/news/i-spy.html' target='_blank'>UCSF: I-Spy 2 Articles</a> </li><li class='seamTextUnorderedListItem'><a href='http://vimeo.com/10266694' target='_blank'>Video: I-SPY 2 Press Conference</a> </li><li class='seamTextUnorderedListItem'><a href='http://vimeo.com/10264209' target='_blank'>Video: NBC News</a> </li></ul>

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

VISITS: 1 visit every 4 weeks, ongoing

PHASE: II

NCT ID: NCT01494662

Neratinib for HER2-Positive Brain Metastases

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

Purpose

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

Who is this for?

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

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

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

VISITS: 2 visits every 3 weeks

PHASE: I-II

NCT ID: NCT01554371

Halaven & Cytoxan for Advanced Breast Cancer

A Phase Ib/II Study of Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies Scientific Title

Purpose

To test the safety and effectiveness of the two drugs when they are given together at different doses to patients with locally advanced or metastatic breast cancer (and other solid tumors).

Who is this for?

Women and men with advanced (stage some stage III or metastatic (stage IV breast cancer. You may have received any number of prior regimens of chemotherapy for metastatic disease. Full eligibility criteria

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All participants will receive the following treatment, based on a 3-week cycle: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halave®) by IV on days 1 and 8</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) by IV on day 1</li></ul>
Combining two or more cancer drugs that work in different ways may be more effective than using one cancer drug at a time. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is approved for treating metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) is approved for treating many different types of cancer, including breast cancer. </li> <li class="seamTextUnorderedListItem">The combination of eribulin and cyclophosphamide 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/NCT01554371' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/chemotherapy/new_research/20101011.jsp' target='_blank'>BreastCancer.org: Eribulin</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/clinicaltrials/results/summary/2011/eribulin0611' target='_blank'>Cancer.gov: Eribulin</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/druglist/cytoxan.jsp' target='_blank'>BreastCancer.org: Cytoxan</a> </li></ul>

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

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT01570998

Targeted Intraoperative Radiotherapy (TARGIT) Registry Trial

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

Purpose

To study the effectiveness and side effects of targeted intraoperative radiotherapy

Who is this for?

Women 45 and older, with stage 0 or stage I breast cancer who will have a lumpectomy (breast conserving surgery) and are considered low risk for a local recurrence. Full eligibility criteria

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All participants will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiotherapy as a single dose after breast conserving surgery</li> </ul> Participants may receive whole breast radiation, if indicated.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation is used to kill any breast cancer cells that may not have been removed during surgery. </li> <li class="seamTextUnorderedListItem">Targeted intraoperative radiotherapy is delivered during surgery immediately after the tumor has been removed. This allows the radiation to accurately target the tissue surrounding the tumor, where the risk of recurrence is highest. </li> <li class="seamTextUnorderedListItem">It takes about 20-35 minutes to provide intraoperative radiotherapy. </li> <li class="seamTextUnorderedListItem">The Targeted Intraoperative Radiotherapy Trial (TARGIT), will follow women who receive this type of radiation therapy for five years, allowing researchers to study its effectiveness and side effects. </li> <li class="seamTextUnorderedListItem">If indicated, participants will also receive whole breast radiation.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01570998' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation/types/intraoperative/' target='_blank'>BreastCancer.org: Intraoperative Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='http://scholar.google.com/scholar?q=intraoperative+radiation+therapy+breast+cancer&hl=en&as_sdt=0&as_vis=1&oi=scholart&sa=X&ei=V-NpUMOGOObmiwKC2IHQDg&ved=0CCkQgQMwAA' target='_blank'>Google Scholar: Intraoperative Radiation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/AboutUs/DrLensBlog/post/2010/06/29/Is-TARGIT-Radiation-Therapy-For-Breast-Cancer-Really-On-Target.aspx' target='_blank'>American Cancer Society: Cancer Blog/TARGIT</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ucsfbreastcarecenter.org/treatment/radiation_oncology.php' target='_blank'>UCSF Breast Care Center: Radiation Oncology</a> </li></ul>

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

VISITS: 2 visits per week, ongoing

PHASE: I

NCT ID: NCT01676753

Dinaciclib With Paclitaxel for Advanced Breast Cancer

A Phase I/Ib Dose-escalation Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumor Malignancies and Assessment of MYC Oncogene Overexpression Scientific Title

Purpose

To determine the safety and effects (good and bad) for the combination of weekly Taxol and dinaciclib in patients with advanced triple negative breast cancer and to identify biomarkers that can predict which tumors will respond to dinaciclib.

Who is this for?

Women and men with advanced (some stage III) and metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-). You must not have received more than two regimens of chemotherapy for metastatic disease. Full eligibility criteria

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All participants will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dinaciclib by IV, weekly on Day 1</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) by IV, weekly on Day 2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01676753' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://scholar.google.com/scholar?hl=en&q=dinaciclib+breast+cancer&btnG=&as_sdt=1%2C5&as_sdtp=' target='_blank'>Google Scholar:Dinaciclib</a> </li></ul>

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

VISITS: At least 1 visit before surgery, followed by 12 follow-up visits

PHASE: III

NCT ID: NCT01805076

MRI, Ultrasound & Mammography Before Surgery in Women with HR- Stage I-II Breast Cancer

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer (A6694) Scientific Title

Purpose

To compare surgical results seen in women who receive mammography, ultrasound and MRI before surgery with surgical results seen in women who receive mammography and ultrasound before surgery.

Who is this for?

Women with stage I or stage II breast cancer who are estrogen receptor negative (ER-). You must not have yet received anti-cancer treatment including surgery. 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">Mammography, ultrasound and MRI before surgery</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammography and ultrasound before surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammography and ultrasound are routinely used before surgery to evaluate breast tumors. </li> <li class="seamTextUnorderedListItem">Researchers think using Magnetic Resonance Imaging (MRI) in addition to mammography and ultrasound before surgery will help doctors evaluate the tumor and make decisions regarding the best surgical treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01805076' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/study/NCT01805076?show_locs=Y#locn' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/research-news/20120515' target='_blank'>Breastcancer.org: Breast MRI Useful Before Breast Cancer Surgery</a> </li><li class='seamTextUnorderedListItem'><a href='http://ecog-acrin.org/clinical-trials/acrin-6694-educational-materials' target='_blank'>Educational Material</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT01969643

SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

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

Purpose

To determine the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A in women with HER2-negative metastatic breast cancer.

Who is this for?

Women with triple negative (ER-, PR-, HER2-) or HER2 negative, estrogen receptor positive metastatic (stage IV) breast cancer that can no longer be treated with a hormone therapy. Full eligibility criteria

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All participants will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A by IV every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibody-drug conjugate (ADC) is a cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells. </li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects. </li> <li class="seamTextUnorderedListItem">SGN-LIV1A is an ADC that targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and delivers a cancer drug called monomethyl auristatin E. </li> <li class="seamTextUnorderedListItem">This study will assess the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A in women with HER2-negative metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01969643' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.thestreet.com/story/12075582/1/seattle-genetics-initiates-phase-1-trial-of-adc-candidate-sgn-liv1a-for-patients-with-liv-1-positive-metastatic-breast-cancer.html' target='_blank'>The Street: SGN-LIV1A</a> </li></ul>

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

VISITS: Monthly visits

PHASE: III

NCT ID: NCT02107703

LY2835219 Plus Faslodex For Advanced ER/PR Positive HER2 Negative Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without LY2835219, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose

To compare the effectiveness of LY2835219 (abemaciclib) and Faslodex with Faslodex alone.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) breast cancer that is estrogen receptor positive and HER2 negative. 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">LY2835219 (abemaciclib) by mouth, daily </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection, once a month</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo by mouth, daily </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection, once a month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are studying new treatments for patients with tumors that are ER+ and/or PR+. (These tumors are also called hormone-receptor positive (HR+). </li> <li class="seamTextUnorderedListItem">LY2835219 (abemaciclib) is a new drug that keeps cancer cells from reproducing by blocking two kinases called CDK 4 and 6. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy that is widely used to treat postmenopausal women with HR+ tumors that have stopped responding to other hormonal therapies. </li> <li class="seamTextUnorderedListItem">This study will compare the effectiveness of LY2835219 (abemaciclib) and Faslodex with Faslodex alone in postmenopausal patients with advanced HR+, 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/NCT02107703' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.lilly.com/releasedetail.cfm?releaseid=848054' target='_blank'>Lilly: Abemaciclib</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/hormonal/erds/faslodex' target='_blank'>BreastCancer.org: Faslodex</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02400476

Neratinib & Imodium after Herceptin for HER2+ Stage I-III Breast Cancer

A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide Scientific Title

Purpose

To see whether women with HER2 positive tumors who take Imodium along with neratinib experience less diarrhea.

Who is this for?

Women with stage I, stage II, or stage III HER2 positive breast cancer who have previously received Herceptin. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Loperamide, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib is a targeted therapy that is currently being studied in clinical trials for HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">These studies have found that diarrhea is one of the common side effects of neratinib. </li> <li class="seamTextUnorderedListItem">Loperamide (Imodium) is an over-the-counter medication used to prevent and treat diarrhea.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02400476' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.medscape.org/viewarticle/586897' target='_blank'>Medscape.org: Neratinib for HER2-positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.webmd.com/drugs/2/drug-4789-4025/loperamide-oral/loperamide-oral/details' target='_blank'>WebMD: Loperamide</a> </li></ul>

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

VISITS: Visits every 3 weeks for 3 months

PHASE: III

NCT ID: NCT02445391

Chemo After 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?

Women and men 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
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: 1-2 visits over 3 weeks

PHASE: NA

NCT ID: NCT02206984

Hormone Therapy Before Surgery for Invasive Lobular Breast Cancer

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

Purpose

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

Who is this for?

Postmenopausal women diagnosed with invasive lobular breast cancer who had not yet had surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups and receive the following over 21 days before surgery: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily </li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), injected into a muscle (like a shot), on days 1 and 14</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Each patient in the study will receive one of the three anti-estrogen drugs the researchers are studying. </li> <li class="seamTextUnorderedListItem">These three drugs are tamoxifen (Nolvadex®), anastrozole (Arimidex®), and fulvestrant (Faslodex®).</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02206984' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT02750826

Weight Loss Program to Prevent Recurrence in Women with HER2-, Stage II-III Breast Cancer

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer (BWEL Study) Scientific Title

Purpose

To see if women who take part in a weight loss program after being diagnosed with breast cancer are less likely to have their cancer come back than those who do not take part in the weight loss program.

Who is this for?

Women with stage I or stage II HER2 negative breast cancer. You must also be overweight or obese. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following over 2 years: Group 1: Health Education Program <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General information about healthy living and breast cancer news, over 2 years</li> </ul> Group 2: Health Education Program and Weight Loss Intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General information about healthy living and breast cancer news, over 2 years</li> <li class="seamTextUnorderedListItem">Telephone calls with trained coaches, about 2 calls per month for 2 years</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02750826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.dana-farber.org/Newsroom/News-Releases/dana-farber-study-testing-the-impact-of-weight-loss-breast-cancer-recurrence.aspx' target='_blank'>Dana Farber News Release</a> </li><li class='seamTextUnorderedListItem'><a href='http://well.blogs.nytimes.com/2016/06/27/putting-breast-cancer-on-a-diet/?rref=collection%2Fsectioncollection%2Fhealth&action=click&contentCollection=health&region=rank&module=package&version=highlights&contentPlacement=7&pgtyp' target='_blank'>New York Times article</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT02822573

Aricept to Improve Memory Loss in Survivors Who Had Chemotherapy

A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment Scientific Title

Purpose

To see whether a drug used to treat memory problems helps breast cancer survivors.

Who is this for?

Women with breast cancer who completed treatment with chemotherapy between 1 and 5 years ago. You must be experiencing memory problems. Full eligibility criteria

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You will be randomly assigned to 1 to 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memory questionnaires</li> <li class="seamTextUnorderedListItem">Donepezil (Aricept®), by mouth, daily, for 6 months</li> <li class="seamTextUnorderedListItem">followed by 3 months of no treatment</li> </ul> Group 2: Placebo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Memory questionnaires</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, for 6 months</li> <li class="seamTextUnorderedListItem">followed by 3 months of no treatment</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02822573' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a697032.html' target='_blank'>MedlinePlus: Donepezil</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT02849496

Veliparib and/or Tecentriq for BRCA+, Stage III-IV Triple Negative Breast Cancer

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

Purpose

To investigate how well two different types of cancer drugs work when they are used alone or together.

Who is this for?

Women and men with stage III or IV triple negative breast cancer. You must also test positive for the inherited BRCA1/2 mutation. 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">Veliparib (ABT-888), by mouth, daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq), by IV, every 3 weeks, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Veliparib (ABT-888), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs being studed in this trial are Veliparib (ABT-888) and atezolizumab (Tecentriq). </li> <li class="seamTextUnorderedListItem">Veliparib (ABT-888) is a new type of targeted drug called a PARP inhibitor. It is available only in clinical trials. </li> <li class="seamTextUnorderedListItem">Tecentriq is a new immunotherapy drug. It is approved to treat bladder cancer and a type 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/NCT02849496' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 3 miles
Investigator Site - San Francisco
San Francisco,CA

VISITS: Varies depending upon treatment

PHASE: III

NCT ID: NCT02915744

A Study of a New Drug (NKTR-102) in Breast Cancer Patients with Stable Brain Metastases

A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine Scientific Title

Purpose

To compare the safety and effects (good and bad) of NKTR-102, a new chemotherapy drug, to a Treatment of Physician's Choice in patients with metastatic breast cancer who have stable brain metastases.

Who is this for?

Women and men with metastatic breast cancer that has spread to your brain. The brain metastases must be considered "stable." You must also have been treated with an anthracycline, a taxane, and capecitabine (Xeloda®). 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">NKTR-102, by IV, once every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treatment of Physician's Choice (eribulin/Halaven®, ixabepilone/Ixempra®, vinorelbine/Navelbine®, gemcitabine/Gemzar®, paclitaxel/Taxol®, docetaxel/Taxotere® or nab-paclitaxel/Abraxane®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The new chemotherapy drug is called NKTR-102. It is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">The Treatment of Physician's Choice will be selected from the following seven standard of care chemotherapies: eribulin (Halaven®), ixabepilone (Ixempra®), vinorelbine (Navelbine®), gemcitabine (Gemzar®), paclitaxel (Taxol®), docetaxel (Taxotere®) or nab-paclitaxel (Abraxane®). All of these drugs are routinely used to treat metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02915744' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=586949' target='_blank'>NCI Drug Dictionary: NKTR-102</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancercommons.org/tag/nktr-102/' target='_blank'>Cancer Commons: Article about NKTR-102</a> </li></ul>

NEAREST SITE: 3 miles
UCSF
San Francisco,CA

VISITS: Coincides with standard of care

PHASE: III

NCT ID: NCT02947685

Targeted and Hormone Therapies plus Ibrance for HER2+, HR+ Metastatic Breast Cancer

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer (PATINA) Scientific Title

Purpose

To compare the safety and effects (good and bad) of using a CDK inhibitor (targeted therapy) with standard of care for HER2+, ER+ advanced breast cancer to standard of care with anti-HER2 and anti-hormone therapies alone.

Who is this for?

Women and men with HER2 positive, estrogen receptor positive advanced (some stage III) or metastatic (stage IV) breast cancer. You must have already had at least 4 and at most 8 cycles of a HER2 targeted drug. 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">Palbociclib (Ibrance®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard anti-HER2 therapy and hormone therapy</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard anti-HER2 therapy and hormone therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted drug being used in this study is palbociclib (Ibrance®). It is approved for treating metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">The standard of care is a HER2-targeted drug and an anti-estrogen drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02947685' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
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 see whether an immunotherapy drug may be effective for treating triple negative breast cancer.

Who is this for?

Women and men with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who received chemotherapy before surgery®called neoadjuvant treatment®and still have cancer cells in their breast and/or lymph nodes. 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>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug (a drug that uses your body's own immune system to help fight cancer) being used in this study is pembrolizumab (Keytruda®). It is approved to treat melanoma and non-small cell lung 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></ul>

NEAREST SITE: 3 miles
University of California San Francisco ( Site 0007)
San Francisco,CA

VISITS: Weekly visits for 6 weeks, then 1 visit every 3 weeks, for up to 2 years

PHASE: I

NCT ID: NCT03010176

MK-1454 and Keytruda for Patients With Advanced Breast Cancer

Phase 1 Open Label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas Scientific Title

Purpose

To determine the best dose and safety of a new immunotherapy drug, MK-1454.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer who have a tumor that has not responded to, or has stopped responding to, other treatments. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-1454, by IV, once a week for 6 weeks, then once every 3 weeks for 2 years </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks for 2 years </li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-1454 is an immunotherapy drug that earlier studies suggest may make tumors more likely to respond to pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">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">Keytruda is approved to treat certain types of cancer, but not breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03010176' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lymphomanewstoday.com/2018/11/05/mk-1454-keytruda-combo-shows-promise-interim-phase-1-data-shows/' target='_blank'>Lymphoma Today: MK-1454/Keytruda Combination Shows Promise in Solid Tumor and Lymphoma Patients</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biopharmadive.com/news/esmo-2018-bavencio-pfizer-rcc-merck-sting-novartis-alpelisib/540263/' target='_blank'>BioPharmadive: ESMO 2018</a> </li></ul>

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

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03056755

Alpelisib plus Endocrine Therapy for HR+, HER2- Advanced Breast Cancer

A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment Scientific Title

Purpose

To investigate the safety and effects (good and bad) of giving the targeted drug alpelisib along with an anti-estrogen drug.

Who is this for?

Women and men with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer. You must have already been treated with a CDK4/6 inhibitor. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (BYL719), by mouth, daily </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 3 weeks </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (BYL719), by mouth daily </li> <li class="seamTextUnorderedListItem">Letrozole, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (BYL719) is a PI3K inhibitor. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and letrozole (Femara®) are the anti-estrogen drugs used 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/NCT03056755' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/publications/contemporary-oncology/2014/november-2014/development-of-pi3k-inhibitors-in-breast-cancer' target='_blank'>OncLive: PI3K Inhibitors</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03076372

MM-310 for Metastatic Triple Negative Breast Cancer

A Phase-1 Study Evaluating the Safety, Pharmacology and Preliminary Activity of MM-310 in Patients With Solid Tumors Scientific Title

Purpose

To determine the best dose, safety and effects (good and bad) of a new type of targeted drug researchers think will be effective in patients with metastatic triple negative breast cancer.

Who is this for?

Women and men with metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MM-310, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The new drug is called MM-310. It delivers the chemotherapy drug docetaxel (Taxotere) directly to cancer cells. </li> <li class="seamTextUnorderedListItem">Results from this study will help researcher determine the best dose of MM-310 to use when it is combined with other anti-cancer drugs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03076372' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.prnewswire.com/news-releases/merrimack-initiates-phase-1-study-of-mm-310-in-solid-tumors-300428182.html' target='_blank'>Study Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.merrimack.com/strategies/mm-310/' target='_blank'>Merrimack.com: MM-310</a> </li></ul>

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

VISITS: 1 visit every 3 weeks for 3 months, then every 3 months for up to 1 year

PHASE: II

NCT ID: NCT03094052

Diarrhea Prevention for HER2+ Breast Cancer Patients Receiving Neratinib and Herceptin or Pertuzumab

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

Purpose

To see whether taking anti-diarrhea medication helps prevent diarrhea in women and men being treated with one approved and one investigational HER2-targeted drug.

Who is this for?

Women and men with stage II or stage III HER2 positive breast cancer. You must also have had chemotherapy and be planning to receive Herceptin. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, as indicated by your doctor</li> <li class="seamTextUnorderedListItem">Neratinib, by mouth, daily, for up to 1 year</li> <li class="seamTextUnorderedListItem">Anti-diarrhea medicine (loperamide) by mouth, daily for 6 weeks, then as needed</li> <li class="seamTextUnorderedListItem">Anti-diarrhea medicine (crofelemer/Mytesi®), by mouth, daily for 6 weeks, then as needed</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The investigational (only available in clinical trials) HER2-targeted drug is neratinib. One of its known side effects is diarrhea. </li> <li class="seamTextUnorderedListItem">The approved HER2-targeted drug is trastuzumab (Herceptin®). </li> <li class="seamTextUnorderedListItem">Crofelemer (Mytesi®) is a medicine used to prevent diarrhea in people being treated for HIV/AIDS. </li> <li class="seamTextUnorderedListItem">Loperamide (Immodium) is an over-the-counter medication used to prevent and treat diarrhea.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03094052' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.fulyzaq.com/' target='_blank'>Crofelemer (Mytesi®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/web-exclusives/fda-accepts-neratinib-nda-for-her2positive-breast-cancer' target='_blank'>OncLive: Neratinib</a> </li></ul>

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

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03095352

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

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

Purpose

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

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer that has spread to the chest wall and cannot be removed by surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment </li> </ul> Group 2: Standard treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is the immunotherapy drug used in this study. It is a PDL-1 inhibitor approved to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is the chemotherapy drug used in this study.</li> <li class="seamTextUnorderedListItem">In this trial, researchers will test tumor biopsies and blood samples before and after treatment in order to learn more about how genes and the immune system affect how tumors respond to immunotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03095352' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

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

PHASE: III

NCT ID: NCT03199885

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

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

Purpose

To compare the safety and effects of the combination of pembrolizumab, trastuzumab, paclitaxel, and atezolizumab with the combination of pembrolizumab, trastuzumab, paclitaxel, and a placebo.

Who is this for?

Women and men who are starting treatment for metastatic (stage IV) breast cancer or have had their breast cancer recur after 6 months of neoadjuvant or adjuvant HER2-targeted therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3-6 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3-6 months</li> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy used to treat HER2-positive breast cancer. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03199885' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>Cancer.gov: Atezolizumab Approval for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/latest-news/fda-approves-keytruda-pembrolizumab-for-any-tumor-with-specific-genetic-change.html' target='_blank'>Cancer.org: FDA Approves Keytruda for Breast Cancer</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03250676

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">H3B-6545, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">H3B-6545 is the experimental anti-estrogen therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03250676' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/77/13_Supplement/DDT01-04' target='_blank'>AACR Abstract: H3B-6545</a> </li></ul>

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

VISITS: 1-2 visits a month, ongoing

PHASE: I-II

NCT ID: NCT03280563

Combination of Immunotherapy and Targeted Therapies for HR+ and HER2- Breast Cancer

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

Purpose

To evaluate the safety and effects (good and bad) of several immunotherapy-based combination treatments.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) breast cancer that is estrogen receptor positive, HER2 negative (ER+, HER2-). Your cancer must have recurred or progressed on your most recent systemic therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 5 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> If your disease progresses while on treatment, you may be eligible to receive a new combination treatment.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a immunotherapy drug. </li> <li class="seamTextUnorderedListItem">PD-L1 (programmed death-ligand 1) inhibitor is approved to treat certain types of bladder and lung cancer</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic) is a targeted therapy. It blocks the MEK protein and is used to treat certain types of melanoma. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a new type of cancer drug that works by blocking the Akt protein</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin) is a monoclonal antibody that keeps tumors from growing by shrinking their supplying blood vessels. Avastin is used to treat HER2-negative metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03280563' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biooncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Information Page: Ipatasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03289962

Personalized Cancer Vaccine plus Atezolizumab for Advanced Breast (and Other) Tumors

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

Purpose

To investigate the safety and effects (good and bad) of using a personalized cancer vaccine alone or with an immunotherapy drug to treat advanced breast cancer.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. You must have progressed on at least one prior therapy for your current diagnosis. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
The personalized cancer vaccine is called RO7198457. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). It works by blocking the PD-L1 (programmed death-ligand 1) protein and is approved to treat certain types of bladder and lung cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03289962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=791183' target='_blank'>NCI Drug Dictionary: RO7198457</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03326102

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 3 miles
Kaiser Permanente - San Francisco (2238 Geary)
San Francisco,CA

VISITS: 3 visits a month, ongoing

PHASE: II-III

NCT ID: NCT03337724

Ipatasertib and Taxol for HER2- Advanced Breast Cancer

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using a new targeted therapy along with paclitaxol (Taxol®) for treating advanced HER2- breast cancer.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) HER2 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">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily (3 weeks on, 1 week off), ongoing </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy, ipatasertib (GDC-0068), blocks a protein called AKt that helps cancer cells divide and grow. </li> <li class="seamTextUnorderedListItem">Taxol is a chemotherapy drug routinely used to treat breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03337724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/57955' target='_blank'>ASCO post: AKT Inhibitor Ipatasertib</a> </li></ul>

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

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

PHASE: II

NCT ID: NCT03344965

Olaparib for Metastatic Breast Cancer with an Inherited Genetic Mutation

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily, ongoing </li> <li class="seamTextUnorderedListItem">Tumor measurements, every 1.5 months for 6 months, then every 3 months thereafter</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy known as a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">PARP helps repair DNA when it becomes damaged. Studies showed that the tumors in individuals who have inherited or acquired a mutation in the BRCA1 or BRCA2 genes are often sensitive to killing by PARP inhibitors.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat recurrent ovarian cancer. </li> <li class="seamTextUnorderedListItem">Patients with inherited BRCA1/2 mutations are NOT eligible for this study</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03344965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/risk/factors/genetics' target='_blank'>Breastcancer.org: Genetics</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/fda-olaparib-breast-brca-mutations' target='_blank'>NCI: Olaparib Approved for Treating Some Breast Cancers with BRCA Gene Mutations</a> </li></ul>

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

VISITS: 2-3 visits a month, ongoing

PHASE: II

NCT ID: NCT03414658

Herceptin and Navelbine With Immunotherapy for Advanced HER2+ Breast Cancer

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

Purpose

To see which of three drug combinations is most effective in treating advanced or metastatic HER2-positive advanced breast cancer.

Who is this for?

Women and men with HER2 positive advanced (stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, 3 times over 1 month</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, 3 times over 1 month</li> <li class="seamTextUnorderedListItem">Avelumab (Bevancio®), by IV, every 2 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, 3 times over 1 month</li> <li class="seamTextUnorderedListItem">Avelumab (Bevancio®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Utomilumab (PF-05082566), by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The drugs being used in this study are trastuzumab (Herceptin®), vinorelbine (Navelbine®) avelumab (Bevancio®) and utomilumab (PF-05082566). </li> <li class="seamTextUnorderedListItem">Herceptin is a targeted therapy routinely used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Navelbine®) is a chemotherapy drug used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Avelumab (Bevancio®) and utomilumab (PF-05082566) are immunotherapies that work by stimulating the body's immune system to go after cancer cells. Both work by blocking a protein called PD-L1. </li> <li class="seamTextUnorderedListItem">Bevancio is approved to treat metastatic Merkel cell carcinoma and urothelial (bladder) cancers. Its use is considered experimental in breast cancer. </li> <li class="seamTextUnorderedListItem">Utomilumab is an experimental treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03414658' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://externalmediasite.partners.org/Mediasite/Play/203c8412eda144b7afc0aae750805b2c1d' target='_blank'>Dana-Farber Cancer Institute: Patient-friendly informational video about this trial</a> </li></ul>

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

VISITS: Daily visits, for 3-6 weeks

PHASE: III

NCT ID: NCT03414970

Hypofractionated Radiation After Mastectomy to Prevent Recurrence in Stage II-III Breast Cancer

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction Scientific Title

Purpose

To compare the safety and effects (good and bad) of hypofractionated radiation therapy to standard radiation therapy.

Who is this for?

Women and men who had a mastectomy to treat stage II, stage IIIa, or stage IIIb 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">Conventional radiation therapy, daily, 5 days a week, for 6 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hypofractionated radiation therapy, daily, 5 days a week for 3-4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hypofractionated radiation is a type of radiation therapy in which larger doses (fractions) of radiation are given in fewer sessions over a shorter period of time than conventional radiation therapy.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03414970' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/research-news/shorter-radiation-better-for-early-stage' target='_blank'>Breastcancer.org: Shorter Radiation Course for Early Stage Breast Cancer</a> </li></ul>

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

VISITS: 4 visits over 2 months

PHASE: I

NCT ID: NCT03517488

XmAb20717 Immunotherapy for Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb20717, by IV, once every 2 weeks, for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb20717 blocks two proteins on immune cells, PD-1 and CTLA4. </li> <li class="seamTextUnorderedListItem">Blocking these proteins helps your immune system see and go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03517488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793410' target='_blank'>NCI drug dictionary: XmAb20717</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/xencor-doses-first-patient-in-phase-1-study-of-xmab20717-dual-checkpoint-inhibitor-for-the-treatment-of-advanced-solid-tumors-300680374.html' target='_blank'>Xencor press release: XmAb20717</a> </li></ul>

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

VISITS: Weekly visits for 2 months, monthly visits thereafter

PHASE: II

NCT ID: NCT03519178

PF-06873600 for Metastatic HER2-Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive the following: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600, by mouth</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600, by mouth</li> <li class="seamTextUnorderedListItem">Endocrine therapy</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600 is a cyclin-dependent kinase (CDK) inhibitor. </li> <li class="seamTextUnorderedListItem">It works by inhibiting the CDK enzymes that help cancer cells grow. </li> <li class="seamTextUnorderedListItem">Patients in the study with hormone-receptor positive breast cancer will also be treated with an anti-estrogen therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03519178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793673' target='_blank'>NCI Drug Dictionary: PF-06873600</a> </li></ul>

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

VISITS: At least 2 visits every 3 weeks

PHASE: I-II

NCT ID: NCT03678883

9-ING-41 Targeted Therapy With or Without Chemotherapy for Patients With Advanced Breast Cancer

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors Scientific Title

Purpose

To determine the safety and the effects (good and bad) of the investigational targeted therapy 9-ING-41 when it is used with or without chemotherapy.

Who is this for?

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

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You will be assigned to receive: Experimental drug alone <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">9-ING-41, by IV, 2 times every 3 weeks </li> </ul> or Experimental drug plus chemo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">9-ING-41, by IV, 2 times every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy (one of the following: gemcitabine, doxorubicin, lomustine, carboplatin, nab-paclitaxel plus gemcitabine, or paclitaxel plus carboplatin)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The drug 9-ING-41 is a type of targeted therapy called a GSK-3β inhibitor. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03678883' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT03678883' target='_blank'>UCSF trial information</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03717415

Targeted Therapy Rebastinib With Carboplatin for Advanced Triple Negative Breast Cancer

An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, dose and effects (good and bad) of the targeted therapy rebastinib (DCC-2036) when used along with carboplatin (Paraplatin®).

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rebastinib (DCC-2036), by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rebastinib targets a receptor called TIE2. Researchers believe blocking this protein will keep tumors from growing and spreading. </li> <li class="seamTextUnorderedListItem">Paraplatin is a chemotherapy drug routinely used to treat advanced and metastatic triple negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03717415' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/rebastinib-tosylate' target='_blank'>NCI: rebastinib tosylate</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.deciphera.com/pipeline/rebastinib/' target='_blank'>Trial Sponsor (Deciphera): Rebastinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-reports-updated-preliminary-phase-1' target='_blank'>Trial Sponsor (Deciphera): Press release</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/carboplatin#who' target='_blank'>Breastcancercare.org.uk: Carboplatin</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03734029

DS-8201a for HER2-Low Advanced Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [DESTINY-Breast04] Scientific Title

Purpose

To compare the safety and effects (good and bad) of the new targeted therapy DS-8201a to the standard of care.

Who is this for?

Women and men with HER2-low advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a, by IV, 1 time every 3 weeks, ongoing </li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy chosen by your doctor: Capecitabine (Xeloda®), Eribulin (Halaven®), Gemcitabine (Gemzar®), Paclitaxel (Taxol®), or Nab-paclitaxel (Abraxane®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your tumor is HER2 low-expressing if the results of your immunohistochemical (IHC) test or Fluorescence In Situ Hybridization (FISH) test for HER2 were 1 (negative) or 2 (borderline).</li> <li class="seamTextUnorderedListItem">DS-8201a is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a topoisomerase I inhibitor directly to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03734029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-adc-ds-8201a' target='_blank'>NCI: anti-HER2 ADC DS-8201a</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03781063

Lasofoxifene or Fulvestrant in ESR1 positive ER+/HER2− Advanced Breast Cancer

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation Scientific Title

Purpose

To compare the safety and effects (good and bad) of lasofoxifene (Fablyn®) with fulvestrant (Faslodex®).

Who is this for?

Postmenopausal women with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer who has been treated with an aromatase inhibitor combined with a cyclin dependent kinase (CDK) 4/6 inhibitor, and has had a cell-free circulating tumor DNA (cDNA) test that shows your tumor has an ESR1 mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene (Fablyn®), by mouth, daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fablyn is a nonsteroidal selective estrogen receptor modulator (SERM). </li> <li class="seamTextUnorderedListItem">It has been approved for use in other countries to treat osteoporosis, but is not approved in the U.S. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with 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/NCT03781063' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/hormone-therapy/fulvestrant-faslodex' target='_blank'>BreastCancerCare.org.uk: Fulvestrant (Faslodex)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.practiceupdate.com/content/lasofoxifene-vs-fulvestrant-for-hr-positive-breast-cancer/77342' target='_blank'>PracticeUpdate: Lasofoxifene vs Fulvestrant for HR-Positive Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
Pacific Hematology Oncology Associates / Quest Clinical Research
San Francisco,CA

VISITS: Weekly visits, ongoing

PHASE: I-II

NCT ID: NCT03838367

Leronlimab & Carboplatin for Metastatic Triple Negative Breast Cancer That Tests CCR5+

A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC) Scientific Title

Purpose

To determine the best dose, safety and effects (good and bad) of leronlimab when it is used along with carboplatin.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that the researchers find tests positive for CCR5 and not have been treated with chemotherapy or a checkpoint inhibitor for metastatic breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leronlimab (PRO 140), by injection, weekly </li> <li class="seamTextUnorderedListItem">Carboplatin, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leronlimab is an investigational targeted therapy that blocks CCR5. </li> <li class="seamTextUnorderedListItem">Carboplatin 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/NCT03838367' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2019/05/07/1818129/0/en/FDA-Grants-CytoDyn-Fast-Track-Designation-for-Leronlimab-PRO-140-in-metastatic-Triple-Negative-Breast-Cancer-an-Unmet-Medical-Need.html' target='_blank'>Drug company information page: Leronlimab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-fast-track-designation-to-leronlimab-for-metastatic-tnbc' target='_blank'>Onclive: Leronlimab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/carboplatin' target='_blank'>Breastcancer.org: Carboplatin</a> </li></ul>

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

VISITS: 2 visits every 3 weeks; or coincides with chemotherapy treatment

PHASE: III

NCT ID: NCT03901339

IMMU-132 in ER/PR+ HER2- Advanced Breast Cancer (TROPICS-02)

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens Scientific Title

Purpose

To compare the safety and effects (good and bad) of an investigational chemotherapy with standard of care chemotherapy.

Who is this for?

Women and men with HER2 negative, estrogen receptor positive metastatic (stage IV) breast cancer that has already been treated with 2, 3 or 4 different chemotherapy regimens. 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">Sacituzumab Govitecan (IMMU-132), by IV, 2 times every 3 weeks</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine), determined by your physician</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The investigational chemotherapy is called sacituzumab govitecan (IMMU-132). </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 this drug targets Trop-2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy drug SN-38.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03901339' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-issues-complete-response-letter-for-sacituzumab-govitecan-in-tnbc' target='_blank'>OncLive: FDA Issues Complete Response Letter for Sacituzumab Govitecan in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>MetastaticTrialTalk: Getting to the Target: Antibody Drug Conjugates in Breast Cancer</a> </li></ul>

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

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT03971409

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe) Scientific Title

Purpose

To look at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-04518600, by IV, every 2 weeks </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab, by IV, once a month</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. </li> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03971409' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/avelumab' target='_blank'>NCI Drug Dictionary: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pf-04518600/' target='_blank'>Immuno-Oncology News: PF-04518600</a> </li><li class='seamTextUnorderedListItem'><a href='https://pfe-pfizercom-prod.s3.amazonaws.com/news/asco/Pfizer_IO_41BB_UtomilumabFactSheet.pdf' target='_blank'>Pfizer oncology: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arraybiopharma.com/our-science/our-pipeline/binimetinib' target='_blank'>Array Biopharma: BINIMETINIB</a> </li></ul>

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

VISITS: Daily visits for 5 or 6.5 weeks

PHASE: NA

NCT ID: NCT01872975

Radiation for Women with Early-Stage Breast Cancer Who Have Chemo Before Surgery

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

Purpose

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

Who is this for?

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

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Participants will be assigned to one of the following groups according to type of surgery received: Post-Lumpectomy: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole Breast Radiation, 5 days a week for 5 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy boost to the lumpectomy cavity 5 days a week for 1.5 weeks </li> </ul> Post-Mastectomy: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No radiation</li> </ul> Post-Lumpectomy: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Whole Breast Radiation, 5 days a week for 5 weeks</li> <li class="seamTextUnorderedListItem">Regional nodal radiation therapy</li> <li class="seamTextUnorderedListItem">Radiation therapy boost to the lumpectomy cavity 5 days a week for 1.5 weeks </li> </ul> Post-Mastectomy: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regional nodal and chest wall radiation therapy 5 days a week for 5 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy given before surgery (neoadjuvant treatment) can kill cancer cells in the lymph nodes. This means a woman who is initially node positive may be node negative at the time of surgery. </li> <li class="seamTextUnorderedListItem">The standard of care for women with early-stage breast cancer who have a lumpectomy is whole-breast radiation. </li> <li class="seamTextUnorderedListItem">Women who have a mastectomy typically do not receive radiation. </li> <li class="seamTextUnorderedListItem">Giving radiation to the lymph nodes following a lumpectomy and giving radiation to the chest wall and lymph nodes following a mastectomy may be more effective.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01872975' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation' target='_blank'>BreastCancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 8 miles
Epic Care
Emeryville,CA

VISITS: Approximately 5 visits

PHASE: NA

NCT ID: NCT01992250

Cryoablation (Freezing) Instead of Surgery & Radiation for Women Age 50+ with Small Tumors

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

Purpose

To see how well cryoablation works to prevent local recurrence in women 50 and older who would have otherwise had surgery and radiation to treat an early-stage invasive breast cancer.

Who is this for?

Women, 50 and older, with stage 0, stage I, or stage II hormone receptor positive (ER+ and/or PR+) and HER2 negative breast cancer. Participants must have a tumor that is classified as Luminal A on a core needle biopsy. Full eligibility criteria

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All participants will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Cryoablation</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cryoablation uses extreme cold to destroy cancerous tumors. </li> <li class="seamTextUnorderedListItem">The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures (-276øF) to freeze and kill the breast tumor. </li> <li class="seamTextUnorderedListItem">The procedure does not leave any significant scarring. The researchers believe that cryoablation can successfully destroy a small tumor (no greater than 2.0 cm).</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01992250' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/annual-report/annual-report-2016/breast-cancer-treatment.html' target='_blank'>MD Anderson Cancer Center: Treatment puts the Freeze on Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/News/59564' target='_blank'>ASCO: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03488693

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 5 visits per week, for 6 weeks

PHASE: II

NCT ID: NCT03598257

Radiation Therapy With or Without Olaparib For Inflammatory Breast Cancer

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

Purpose

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

Who is this for?

Women with stage III inflammatory breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, for 6 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy, 5 days a week, for 6 weeks</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy, 5 days a week, for 6 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with a BRCA genetic mutation. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03598257' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.swog.org/clinical-trials/s1706' target='_blank'>SWOG Cancer Research Network: Trial information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/olaparib' target='_blank'>NCI: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2018/fda-olaparib-breast-brca-mutations' target='_blank'>NCI: Olaparib Approved for Treating Some Breast Cancers with BRCA Gene Mutations</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/inflammatory' target='_blank'>Breastcancer.org: Inflammatory Breast Cancer</a> </li></ul>

NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA

VISITS: Coincides with chemotherapy treatment

PHASE: NA

NCT ID: NCT02728596

CSF to Prevent Neutropenia (Infection) Caused by Chemotherapy (TrACER)

A Pragmatic Trial to Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as a Prophylaxis for Patients Receiving Chemotherapy With Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) Scientific Title

Purpose

To evaluate the benefits of using guidelines that have been developed to direct specific patients who are receiving certain types of chemotherapy to receive CSF to reduce their risk of neutropenia.

Who is this for?

Women and men who are receiving chemotherapy as part of breast cancer treatment and have an intermediate risk of developing neutropenia (a low-white blood cell count). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CSF while receiving chemotherapy treatment </li> <li class="seamTextUnorderedListItem">Quality-of-Life Assessments</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patients who develop neutropenia--a fever and low white cell blood count--are at increased risk of developing an infection. </li> <li class="seamTextUnorderedListItem">CSF (Colony-stimulating factors) are medications sometimes given to patients receiving chemotherapy to prevent neutropenia. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02728596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/side-effects/neutropenia' target='_blank'>Cancer.net: Neutropenia</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/side-effects/fever-neutropenic-fever-and-their-relationship-to-chemotherapy.aspx' target='_blank'>ChemoCare: Fever, Neutropenic Fever, and their Relationship to Chemotherapy</a> </li></ul>

NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03418961

Carvediol to Prevent Heart Problems in Patients with Metastatic HER2+ Breast Cancer

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III Scientific Title

Purpose

To investigate whether giving women and men with HER2+ breast cancer a beta-blocker can help prevent heart problems caused by cancer treatments.

Who is this for?

Women and men with HER2 positive metastatic (stage IV) breast cancer who are starting or continuing a trastuzumab-based anitHER2 therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carvediol, by mouth, daily for up to 2 years</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No intervention</li> </ul> Group 3: If you are already taking taking a beta blocker, ARB, or ACE inhibitor <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation for up to 2 years</li></ul>
The beta-blocker being used in this study is carvediol. It is used to treat heart failure and high blood pressure.
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03418961' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/side_effects/heart_probs' target='_blank'>Breastcancer.org: Heart Problems</a> </li></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?

Women and men, 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: 27 miles
Stanford University Hospitals and Clinics
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02401347

Talazoparib for HER2-Negative Advanced Breast Cancer

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

Purpose

To determine the safety and effects (good and bad) of talazoparib.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer that is HER2 negative, but not BRCA positive. You must have had at least one prior regimen of chemotherapy for metastatic disease. Full eligibility criteria

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All participants will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (BMN 673), by mouth, daily</li></ul>
Studies suggest PARP inhibitors may be effective in some types of breast cancer. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (BMN 673) is a PARP inhibitor. Early studies suggest talazoparib may be effective in cancer patients who have an inherited BRCA1/2 mutation. It may also be effective in patients who do not have a BRCA1/2 mutation.</li> <li class="seamTextUnorderedListItem">Participants will have their tumor tested for genetic mutations to determine eligibility.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02401347' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01034033

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 27 miles
Local Institution- Palo Alto
Stanford,CA

VISITS: Visits every 2 to 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT02983045

NKTR-214 with Opdivo for Advanced Triple Negative Breast Cancer (and Other Solid Tumors)

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies (PIVOT) Scientific Title

Purpose

To investigate the best dose, safety and effect (good and bad) of using an investigational immunotherapy along with the immunotherapy drug Nivolumab (Opdivo®) to treat advanced or metastatic triple negative breast cancer.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKTR-214, by IV, every 2 or 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 or 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The investigational therapy NKTR-214 targets a protein found on immune cells called CD-122. Targeting the protein gets the immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo® is a type of immunotherapy called a PD-1 (programmed cell death-1) inhibitor. It is approved to treat certain types of cancers, but not breast cancer. </li> <li class="seamTextUnorderedListItem">Researchers believe using the two immunotherapies together will treat cancer more effectively.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02983045' 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='http://www.nektar.com/pipeline/rd-pipeline/nktr-214' target='_blank'>Nektar: NKTR-214</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/nktr-214/' target='_blank'>Immuno-Oncology News: NKTR-214</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University /ID# 206949
Stanford,CA

VISITS: 1 visit every 2 or 4 weeks, ongoing

PHASE: I

NCT ID: NCT03071757

ABBV-36 and ABBV-181 in Advanced Triple Negative Breast (and other) Cancers

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety and best dose of the investigational drug ABBV-368 when it is given with or without the investigational drug ABBV-181.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and have already had a treatment that your cancer did not respond to or has stopped responding to. 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">ABBV-368, by IV, every 2 or 4 weeks, ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-368, by IV, every 4 weeks, ongoing</li> <li class="seamTextUnorderedListItem">ABBV-181, by IV</li> <li class="seamTextUnorderedListItem">18F PET scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-368 is an anti-OX40 monoclonal antibody that targets a protein found on some T cells. By targeting these proteins, the researchers think the drug will help other T cells kill cancer cells. </li> <li class="seamTextUnorderedListItem">ABBV-181 is a new type of PD-1 inhibitor. These are immunotherapy drugs that get the immune system to kill cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">The study will also see if a new type of PET scan dye can help researchers see whether the drugs are activating an immune response. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03071757' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-368.html' target='_blank'>Drug Company Information Page: ABBV-368</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/monoclonal-antibodies' target='_blank'>Cancer Research UK: Monoclonal Antibodies</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/abbv-181/' target='_blank'>Immuno-Oncology News: ABBV-181</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/792559' target='_blank'>NCI Drug Dictionary: ABBV-368</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.6050' target='_blank'>ASCO Abstract: Novel PET imaging with [18F]F-AraG</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Health Care
Stanford,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03102320

Anetumab Ravtansine in Advanced Triple Negative Tumors That Are Mesothelin-Positive

Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies (ARCS-Multi) Scientific Title

Purpose

To test the safety and effects (good and bad) of anetumab ravtansine, a targeted therapy that blocks mesothelin, a protein that helps cells stick together.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER-) that tests positive for mesothelin, a protein that some tumors overproduce. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anetumab ravtansine (BAY94-9343), by IV, once every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anetumab ravtansine is a targeted therapy that blocks mesothelin, a protein that helps cells stick together.</li> <li class="seamTextUnorderedListItem">Mesothelin is a protein that some tumors overproduce.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03102320' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/anetumab-ravtansine-bay-94-9343-drug-description/' target='_blank'>ADCReview: Anetumab Ravtansine (BAY 94-9343)</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03170960

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy drug Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03170960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>Medlineplus: Cabozantinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.1026' target='_blank'>ASCOPubs.org: A phase II study of cabozantinib alone or in combination with trastuzumab in patients with breast cancer brain metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI: Atezolizumab Approved for Some Patients with TNBC</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Cancer Institute
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03330405

Avelumab Plus Talazoparib to Treat Advanced Breast Cancer

A Phase 1b/2 Study To Evaluate Safety And Anti Tumor Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumors Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using an immunotherapy agent along with a targeted therapy to treat advanced breast cancer.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer that is triple negative or estrogen receptor positive . You must not be a candidate for currently available therapies. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®)</li> <li class="seamTextUnorderedListItem">Talazoparib (BMN-637)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is abelumab (Bavencio®). It blocks a protein called PD-L1 (programmed death-ligand 1). </li> <li class="seamTextUnorderedListItem">Talazoparib (BMN-637) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03330405' 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></ul>

NEAREST SITE: 27 miles
Stanford Women Cancer Center
Stanford,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03455270

G1T48 for Advanced ER+ HER2- Breast Cancer

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of a using the hormonal therapy G1T48 to treat ER positive, HER2 negative advanced or metastatic breast cancer.

Who is this for?

Women with ER positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer and have been treated with an aromatase inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">G1T48 (oral SERD), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">G1T48 is type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03455270' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.g1therapeutics.com/pages/pipeline/G1T48.htm' target='_blank'>Sponsor site: G1T48</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Women's Cancer Center
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03499353

Alazoparib Before Surgery in Triple Negative Tumors With an Inherited BRCA Mutation

A PHASE 2, NON-RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI-CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE-NEGATIVE BREAST CANCER Scientific Title

Purpose

To look at the effect that talazoparib (Talzenna®) has on triple negative breast tumors when it is given before surgery.

Who is this for?

Women and men with triple negative (ER-/PR-/HER2-) early stage (stage I, II or IIIA) breast cancer and an inherited BRCA 1/2 mutation and not have had any treatment for your current breast cancer. Full eligibility criteria

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, once a day for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talzenna is a type of targeted therapy called a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">It is approved to treat patients with an inherited BRCA mutation who have HER2‑negative locally advanced or metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03499353' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-gbrcam-her2-negative-locally-advanced-or-metastatic-breast-cancer' target='_blank'>FDA: Talazoparib Approval</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/talzenna' target='_blank'>Breastcancer.org: Talzenna</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Cancer Center ( Site 0072)
Palo Alto,CA

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

PHASE: III

NCT ID: NCT03725059

Chemotherapy & Endocrine Therapy With or Without Pembrolizumab in ER+ and HER2- Stage I, II or III Breast Cancer

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

Purpose

To compare the effectiveness of giving the immunotherapy pembrolizumab (Keytruda®) along with standard of care chemotherapy pre-surgery and hormone therapy post-surgery to using chemotherapy and hormone therapy alone.

Who is this for?

Women and men with estrogen receptor (ER) positive HER negative stage I, II or III breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Pembrolizumab plus standard of care Before surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel, by IV, weekly, for 1 month followed by</li> <li class="seamTextUnorderedListItem">Doxorubicin or epirubicin and cyclophosphamide, by IV, every 3 weeks, for 5 months</li> </ul> After surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks, for 7 months</li> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, daily, for 10 years</li> </ul> Group 2: Placebo plus standard of care Before surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel, by IV, weekly, for 1 month followed by</li> <li class="seamTextUnorderedListItem">Doxorubicin or epirubicin and cyclophosphamide, by IV, every 3 weeks, for 5 months</li> </ul> After surgery and radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, for 7 months</li> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, daily, for 10 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03725059' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://keynoteclinicaltrials.com/trials/breast-cancer' target='_blank'>Keynote Trials: Investigational Immunotherapy Trials for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm' target='_blank'>FDA: FDA approves first cancer treatment for any solid tumor with a specific genetic feature</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/hematology-oncology/breast-cancer/news/online/%7Bf4b314b6-7cb8-470f-ae44-0cddfe7762e7%7D/addition-of-pembrolizumab-to-chemotherapy-demonstrates-promise-in-triple-negative-breast-cancer' target='_blank'>HemOncToday: Addition of pembrolizumab to chemotherapy demonstrates promise in triple-negative breast cancer</a> </li></ul>

NEAREST SITE: 28 miles
Kaiser Permanente - Northern California
Vallejo,CA

VISITS: Please contact research site

PHASE: NA

NCT ID: NCT03061305

Molecular Profiling to Study Treatment Selection for Advanced Breast Cancer

Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment Selection (STRATA) Scientific Title

Purpose

To profile a sample of your tumor and to see if there are treatments or clinical trials that target the mutations or biomarkers found in your tumor.

Who is this for?

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

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Molecular profiling will be done on your tumor sample at no cost.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Molecular profiling of a tumor may identify genetic mutations or biomarkers that suggest the tumor is likely to respond to a currently available targeted therapy. </li> <li class="seamTextUnorderedListItem">In this study, researchers will profile a sample of your tumor. </li> <li class="seamTextUnorderedListItem">Your doctor will be told if there are treatments or clinical trials for patients with the mutations or biomarkers found in your tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03061305' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/broad-molecular-profiling-tests' target='_blank'>Breastcancer.org: Broad Molecular Profiling Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://unclineberger.org/research/octr/our-research/strata-trial' target='_blank'>UNC: Strata Trial</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Cancer Center
Stanford,CA

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

PHASE: I-II

NCT ID: NCT03215511

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 1 visit every 3 weeks for 1.5 years

PHASE: I

NCT ID: NCT03364348

PF-05082566 With Kadcyla® or Trastuzumab For Advanced HER2 Positive Breast Cancer

A Phase 1B Dose Escalation Trial of Human Anti-4-1BB Agonistic Antibody PF-05082566 in Combination With Adotrastuzumab-Emtansine or Trastuzumab in Patients With HER2-Positive Advanced Breast Cancer Scientific Title

Purpose

To look at the safety and effects (good and bad) of using utomilumab (PF-05082566) with trastuzumab emtansine (Kadcyla®) or trastuzumab (Herceptin).

Who is this for?

Women and men with HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Emtansine (Kadcyla®), by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Utomilumab (PF-05082566), by IV, every 3 weeks </li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks </li> <li class="seamTextUnorderedListItem">Utomilumab (PF-05082566), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets 4-1BB (CD-137), a molecule that stimulates the immune system. </li> <li class="seamTextUnorderedListItem">Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Kadcyla is an antibody-drug conjugate (ADC). It uses Herceptin to deliver the chemotherapy drug DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03364348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/utomilumab/' target='_blank'>Immuno-oncology News: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.hematologyandoncology.net/archives/april-2017/antibody-drug-conjugates-in-breast-cancer/' target='_blank'>Clinical Advances in Hematology & Oncology: ADC in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.roche.com/media/releases/med-cor-2013-02-22.htm' target='_blank'>Roche: Kadcyla® Approval</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University Medical Center
Palo Alto,CA

VISITS: 4 visits every 6 weeks for 2 years

PHASE: II

NCT ID: NCT03567720

Tavo & Pembrolizumab (Immunotherapy) in Advanced Triple Negative Tumors

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

Purpose

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

Who is this for?

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

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

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03621982

ADCT-301 in Patients With Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301, by IV, once every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301 is a new type of targeted therapy that combines the monoclonal antibody HuMax®-TAC™ with a new type of chemotherapy drug called PBD. </li> <li class="seamTextUnorderedListItem">The monoclonal antibody brings the chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03621982' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/editorial/adct-301-a-novel-antibody-drug-conjugate-against-lymphomas-moves-into-phase-i-clinical-trial/' target='_blank'>ADC Review: ADCT-301</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Stanford,CA

VISITS: Daily visits for 5 days, followed by surgery

PHASE: NA

NCT ID: NCT03909282

Radiation Therapy Before Surgery For DCIS

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

Purpose

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

Who is this for?

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

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

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

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I

NCT ID: NCT02994953

Two Immunotherapy Drugs for Advanced Breast Cancer

A Basket Study: A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors (COMBO) Scientific Title

Purpose

To investigate the safety, side effects and best dose of the immunotherapy drug NHS-IL12 when it is given in combination with the immunotherapy drug avelumab.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">NHS-IL12, by injection, every 4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NHS-IL12 is an investigational drug. </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio) is currently approved for treating certain types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02994953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm547965.htm' target='_blank'>FDA: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=710539' target='_blank'>NCI Drug Dictionary: NHS-IL12</a> </li></ul>

NEAREST SITE: 53 miles
St. Joseph Health Medical Group - Annadel Medical Group
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03584009

Fulvestrant and Venetoclax for ER+, HER2- Advanced Breast Cancer

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy Scientific Title

Purpose

To compare the effects of fulvestrant (Faslodex®) and venetoclax (Venclexta®) to fulvestrant alone in women with advanced estrogen receptor positive, HER2 negative breast cancer who have already been treated with a CDK 4/6 inhibitor.

Who is this for?

Women with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer who have already been treated with a CDK 4/6 inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Venetoclax (Venclexta®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">Venetoclax (Venclexta®) is targeted therapy approved to treat certain types of blood cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03584009' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, for 2 years

PHASE: I-II

NCT ID: NCT03761914

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

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

Purpose

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

Who is this for?

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

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You will be given the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GM-CSF, by injection, before Galinpepimut-S</li> <li class="seamTextUnorderedListItem">Galinpepimut-S, by injection, every 3 weeks, for up to 2 years</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Galinpepimut-S is a vaccine that targets the protein WT1. </li> <li class="seamTextUnorderedListItem">Higher than normal amounts of this protein are found on the surface of breast and certain other cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03761914' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sellaslifesciences.com/galinpepimut-s-gps-therapy/' target='_blank'>Trial Sponsor Sellas Lifescience: Galinpepimut-S Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/galinpepimut-s/' target='_blank'>Immuno-Oncology News: Galinpepimut-S</a> </li><li class='seamTextUnorderedListItem'><a href='https://pharmaphorum.com/views-and-analysis/asco-2017-breast-cancer-keytruda/' target='_blank'>Pharmaphorum: ASCO 2017: Breast cancer next target for Keytruda</a> </li></ul>

NEAREST SITE: 74 miles
UC Davis Comprehensive Cancer Center
Sacramento,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02500199

Sunitinib for Metastatic HER2+ Breast Cancer That Has Progressed on HER2+ Therapies

A Two-part Phase I, Open Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pyrotinib in Patients With HER2 Positive Solid Tumors Who Failed Prior HER2 Targeted Therapy Scientific Title

Purpose

To determine the safety, effects (good and bad) and the best dose of pyrotinib.

Who is this for?

Women and men with HER2 positive metastatic (stage IV) breast cancer that has stopped responding to other HER2 targeted therapies. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pyrotinib, by mouth, daily</li></ul>
Researchers are studying new ways to treat metastatic HER2+ breast cancer that has stopped responding to HER2-targeted therapies. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pyrotinib, a tyrosine kinase inhibitor, is an experimental targeted therapy. It targets both HER1 and HER2.</li> <li class="seamTextUnorderedListItem">Your cancer must have progressed after having been on at least two prior HER2-targeted therapies, including trastuzumab (Herceptin®) and/or pertuzumab (Perjeta®), or T-DM1 (Kadcyla®), or lapatinib (Tykerb®).</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02500199' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 74 miles
UC Davis Medical Center
Sacramento,CA

VISITS: At least 3 visits

PHASE: NA

NCT ID: NCT02366806

Individualized Radiotherapy Education for Patients with Early-Stage Breast Cancer

Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer Scientific Title

Purpose

To compare the benefits of a standard radiation education plan to a personalized radiation education plan.

Who is this for?

Women who are scheduled to receive radiation therapy for stage I, stage II, or stage III breast cancer at the University of California, Davis. Full eligibility criteria

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Participants will be randomly assigned to 1 of 2 groups: Group 1: Standard <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard education about treatment plan</li> <li class="seamTextUnorderedListItem">3 quality of life questionnaires during treatment</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In-depth education about treatment plan</li> <li class="seamTextUnorderedListItem">3 quality of life questionnaires during treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The standard of care for treating early-stage breast cancer is a lumpectomy followed by radiation. </li> <li class="seamTextUnorderedListItem">Prior to starting radiation, patients typically receive general information about radiation therapy and its potential side effects. </li> <li class="seamTextUnorderedListItem">An in-depth, personalized treatment education plan may be more beneficial.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02366806' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/radiation' target='_blank'>BreastCancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center ( Site 0005)
Sacramento,CA

VISITS: 1 visit every 3 weeks, for 2 years

PHASE: II

NCT ID: NCT03797326

Pembrolizumab with Lenvatinib in Previously Treated Advanced Triple Negative Breast Cancer

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005) Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using pembrolizumab (Keytruda®) along with lenvatinib (Lenvima®).

Who is this for?

Women and men with triple negative (ER-, PR-, HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer who have already had one or two treatment regimens. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 2 years </li> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of cancers, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Lenvima is a targeted therapy that blocks vascular endothelial growth factor receptor 2 (VEGFR2). </li> <li class="seamTextUnorderedListItem">It is approved for treating patients with certain types of thyroid, kidney and liver cancers. </li> <li class="seamTextUnorderedListItem">Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study will also include people with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03797326' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/pembrolizumab' target='_blank'>NCI drug dictionary: Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/lenvatinibmesylate' target='_blank'>NCI drug dictionary: Lenvatinib</a> </li></ul>

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

VISITS: At least 1 visit per month for 6 months

PHASE: I

NCT ID: NCT03970382

Personalized Immunotherapy With or Without Opdivo for HR+ Metastatic Breast Cancer

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

Purpose

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

Who is this for?

Women and men with metastatic (stage IV) estrogen receptor-positive breast cancer that has been treated with at least one standard therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), once a month, for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1 makes a patient's T cells target a neoepitope (neoE) that is found on their cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03970382' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/798453' target='_blank'>NCI Drug Dictionary: gene-edited autologous neoantigen-targeted NeoTCR-P1 T cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT03975647

T-DM1 and Tucatinib for Advanced HER2+ Breast Cancer

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose

To compare the effects (good and bad) and effectiveness of tucatinib and TDM1 with T-DM1 and a placebo.

Who is this for?

Women with locally advanced (stage III) or metastatic (stage IV) HER2 positive breast cancer who have previously been treated with a taxane and trastuzumab (Herceptin®). 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">Tucatinib, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib is an investigational HER2 targeted therapy. </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate. It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03975647' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/tucatinib-shows-promise-in-patients-with-breast-cancer-and-brain-metastases' target='_blank'>OncLive: Tucatinib Shows Promise in Patients With Breast Cancer and Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/news/tucatinib-shows-promise-phase-i-study-her2-positive-breast-cancer' target='_blank'>CancerNetwork:Tucatinib Shows Promise in Phase I Study of HER2-Positive Breast Cancer</a> </li></ul>

NEAREST SITE: 86 miles
Pacific Cancer Care
Monterey,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03523585

DS-8201a Versus Standard of Care for HER2 Positive Advanced Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T DM1 [DESTINY-Breast02] Scientific Title

Purpose

To compare the effects (good and bad) of an experimental HER2 targeted therapy called DS-8201 to the standard of care in patients with advanced breast cancer who have already been treated with the HER2 targeted therapy Kadcyla.

Who is this for?

Women and men with HER2 positive, advanced (some stage III) or metastatic (stage IV) breast cancer and have already been treated with T-DM1 (Kadcyla®). Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a, by IV (please contact research site for treatment schedule)</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times per day</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> </ul> Group 3: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times per day</li> <li class="seamTextUnorderedListItem">Lapatinib (Tykerb®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a (Trastuzumab deruxtecan) is an experimental HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is approved to treat HER2-positive metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03523585' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li></ul>

NEAREST SITE: 86 miles
Pacific Cancer Care
Monterey,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03529110

DS-8201a Versus T-DM1 for HER2-Positive Advanced Breast Cancer

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Scientific Title

Purpose

To compare the safety and effects (good or bad) of two different HER2-targeted therapies, DS-8201a and T-DM1 (Kadcyla®).

Who is this for?

Women and men with HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer who have already been treated with trastuzumab (Herceptin®) and a taxane-based chemotherapy. 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">DS-8201a, by IV (please contact research site for treatment schedule)</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-DM1, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a (Trastuzumab deruxtecan) is an experimental HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is approved to treat HER2-positive metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03529110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/.../fda-grants-ds8201-breakthrough-designation-for -her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Kadcyla</a> </li></ul>

NEAREST SITE: 158 miles
California Cancer Associates for Research and Excellence
Fresno,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03786094

Eribulin With or Without Balixafortide in HER2 Negative Advanced Breast Cancer

An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Scientific Title

Purpose

To compare the safety, effectiveness and side effects of using eribulin (Halaven®) alone or in combination with balixafortide.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer that has been treated with 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">Eribulin (Halaven®), by injection</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by injection</li> <li class="seamTextUnorderedListItem">Balixafortide (POL6326), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Halaven is a chemotherapy drug used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">Balixafortide is an investigational immunotherapy drug that targets CXCR4.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03786094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/eribulin' target='_blank'>Cancer Research UK: Eribulin (Halaven)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/news/fda-grants-balixafortide-fast-track-designation-for-treatment-of-metastatic-breast-cancer-subset' target='_blank'>Targeted Oncology: FDA Grants Balixafortide Fast Track Designation for Treatment of MBC Subset</a> </li></ul>

NEAREST SITE: 183 miles
Radiation Oncology Associates
Reno,NV

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03633331

Ibrance and Hormone Therapy for Adults Age 70 & Older with ER+, HER2- Metastatic Breast Cancer

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of giving the targeted therapy palbociclib (Ibrance®) along with a hormone therapy in older adults.

Who is this for?

Women and men 70 or older with ER positive HER2 negative metastatic (stage IV) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, for 3 out of every 4 weeks</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®), chosen by your doctor</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ibrance is approved to treat metastatic breast cancer in combination with a type of hormone therapy called an aromatase inhibitor. </li> <li class="seamTextUnorderedListItem">The two aromatase inhibitors being used in this trial are letrozole (Femara®) and fulvestrant (Faslodex®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03633331' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Ibrance</a> </li></ul>

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

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT02648477

Keytruda + Chemo or an Aromatase Inhibitor for HER2-Negative Metastatic Breast Cancer

MK-3475 (Pembrolizumab) in Combination With an Anthracycline or Anti-estrogen Therapy in Patients With Triple Negative and Hormone Receptor Positive (HR+ HER2-) Metastatic Breast Cancer Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using Keytruda with chemotherapy or hormone therapy.

Who is this for?

Women and men with metastatic (stage IV) breast cancer that is either triple negative or HER2 negative and estrogen receptor positive . You must not have been treated previously with Keytruda. Full eligibility criteria

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Participants will be assigned to 1 of 2 groups: Group 1: Triple-Negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV over 30 minutes every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 3 weeks, for 4.5 months</li> </ul> Group 2: HR-Positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Physician's choice aromatase inhibitor, by mouth, daily, for up to 2 years</li></ul>
Patients with triple negative tumors will receive Adriamycin along with Keytruda, while patients with hormone-sensitive tumors will receive an aromatase inhibitor along with Keytruda. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an immunotherapy drug that targets the programmed cell death (PD-1) protein. Blocking this protein allows the body's immune system to attack cancer cells. </li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) is a chemotherapy drug commonly used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Aromatase inhibitors (anastrozole/Arimidex®, letrozole/Femara®, exemestane/Aromasin®) are used to treat hormone-sensitive tumors in postmenopausal women.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02648477' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02648477' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/20659' target='_blank'>ASCO Post: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/hormonal/aromatase_inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitor</a> </li></ul>

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

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT02778685

Keytruda, Femara & Ibrance for ER+ Metastatic Breast Cancer After Femara & Ibrance

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

Purpose

To see if adding an immunotherapy drug to Femara and Ibrance will make the combination work better in women who already tried it.

Who is this for?

Women with estrogen receptor positive, HER2 negative, metastatic (stage IV) breast cancer. You must have already been treated with letrozole (Femara®) and palbociclib (Ibrance®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Femara and Ibrance are an approved breast cancer combination. </li> <li class="seamTextUnorderedListItem">Femara is an anti-estrogen drug. </li> <li class="seamTextUnorderedListItem">Ibrance is a targeted treatment. </li> <li class="seamTextUnorderedListItem">The immunotherapy drug that will be used in this study is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda is used to treat certain types cancers, including breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02778685' target='_blank'>ClinicalTrials.gov</a> </li></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?

Women and men 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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What's being studied?
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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: 336 miles
Ronald Reagan UCLA Medical Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02554812

Using Two Immunotherapy Drugs to Treat Metastatic Triple Negative Breast Cancer

A Phase 1b/2 Open-Label Study To Evaluate Safety, Clinical Activity, Pharmacokinetics And Pharmacodynamics Of Avelumab (MSB0010718C) In Combination With Other Cancer Immunotherapies In Patients With Advanced Malignancies Scientific Title

Purpose

To study the safety of avelumab and determine the best dose of it to use along with PF-05082566.

Who is this for?

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

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab plus PF-05082566 (schedule determined by the physician)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Using two immunotherapy drugs together may kill more cancer cells than using one alone. </li> <li class="seamTextUnorderedListItem">Avelumab and PF-05082566 are two new immunotherapy drugs now in clinical trials. </li> <li class="seamTextUnorderedListItem">Both work by blocking a protein called PD-L1. </li> <li class="seamTextUnorderedListItem">Blocking this protein allows the immune system to find and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Some of these patients will receive the immunotherapy drug PF-04518600 along with avelumab.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02554812' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02554812?term=NCT02554812&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.pfizer.com/news/press-release/press-release-detail/asco_2016_pivotal_avelumab_study_shows_positive_results_in_metastatic_merkel_cell_carcinoma' target='_blank'>Pfizer: Avelumab Study</a> </li></ul>

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02866994

An Internet-based Support Program for Women with Metastatic Breast Cancer

Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO) Scientific Title

Purpose

To study whether women with metastatic breast cancer benefit from creating a personal website about their breast cancer experience that they can share with friends, family members and other women diagnosed with breast cancer.

Who is this for?

Women with metastatic (stage IV) breast cancer who live in the greater Los Angeles area. Full eligibility criteria

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You will participate in a 3-hour workshop to create a personal website and chronicle your breast cancer experience.
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02866994' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: 6-8 visits over 4.5 months

PHASE: NA

NCT ID: NCT03025139

Mindfulness Meditation & Survivorship Education After DCIS & Stage I-III Breast Cancer

Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors (Pathways to Wellness) Scientific Title

Purpose

To compare the benefits of mindfulness meditation and survivorship education for reducing symptoms of depression.

Who is this for?

Women diagnosed with DCIS or stage I, stage II, or stage III breast cancer within the last five years. Your must have been 45 or younger at the time of diagnosis. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Mindfulness Meditation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2-hour mindfulness meditation class, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">followed by 1-hour guided meditation and discussion session, monthly for 2 months</li> </ul> Group 2: Survivorship Education <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2-hour survivorship education class, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Electronic newsletters, monthly</li> </ul> Group 3: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care (no intervention)</li> <li class="seamTextUnorderedListItem">Option to participate in the mindfulness meditation classes or survivorship education classes after 9 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mindfulness meditation may help you change the way you respond to thoughts and life events. </li> <li class="seamTextUnorderedListItem">Survivorship education tailored to younger survivors may help reduce stress and improve well-being and quality of life.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03025139' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancer.ucla.edu/patient-care/jccc-in-the-community/breast-cancer-partnerships/ucla-research-study-for-young-women-survivors-of-breast-cancer' target='_blank'>UCLA: Study Information</a> </li></ul>

NEAREST SITE: 336 miles
Research Site
Los Angeles,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03256344

Immunotherapy With Tecentriq for TNBC With Liver Metastases

A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases Scientific Title

Purpose

To evaluate the safety and effects of injecting the cancer drugs talimogene laherparepvec (Imlygic®) and atezolizumab (Tecentriq®) directly into the liver to treat liver metastases.

Who is this for?

Women and men with metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that has spread to the liver. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talimogene laherparepve (Imlygic® or T-VEC), by injection, every 3 weeks, for up to 9 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlygic is an immunotherapy approved to treat advanced melanoma. It is injected directly into the melanoma tumors. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat metastatic triple negative breast cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients who have colorectal cancer that has spread to the liver.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03256344' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/talimogene-laherparepvec.aspx' target='_blank'>ChemoCare: Talimogene Laherparepvec</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616006.html' target='_blank'>MedLine Plus: Talimogene Laherparepvec</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/news/tvec-injections-safe-in-patients-with-advancedstage-liver-metastases' target='_blank'>Targeted Oncology News: T-VEC Injections Safe in Patients with Advanced-Stage Liver Metastases</a> </li></ul>

NEAREST SITE: 336 miles
(IRB#17-001086) Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03284723

PF-06804103 in HER2+ Advanced Breast Cancer

A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06804103 IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) POSITIVE SOLID TUMORS Scientific Title

Purpose

To study the safety and effects (good and bad) of PF-06804103 (an anti-body drug conjugate).

Who is this for?

Women and men with locally advanced (stage III) or metastatic (stage IV) HER2+ breast cancer and have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06804103 by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06804103 is an antibody drug conjugate (ADC). It uses a HER2-targeted agent to deliver the chemotherapy drug Auristatin-0101 directly to HER2+ cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of HER2+ solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03284723' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-vc0101-adc-pf-06804103' target='_blank'>NCI Dictionary: PF-06804103</a> </li></ul>

NEAREST SITE: 336 miles
UCLA
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT03514121

FPA150 and Pembrolizumab for Advanced Breast Cancer

A Phase 1a/1b Study of FPA150, an Anti-B7-H4 Antibody, in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of using FPA150 alone or in combination with pembrolizumab.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to other treatment options. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FPA150</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">FPA150 is an investigational immunotherapy drug that targets B7-H4. It is a checkpoint inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03514121' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fiveprime.com/programs/FPA150/' target='_blank'>Drug company information page: FPA150</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/news/pembrolizumab-demonstrates-antitumor-activity-in-high-tmb-metastatic-breast-cancer' target='_blank'>OncLive: Pembrolizumab Demonstrates Antitumor Activity in High TMB Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 336 miles
Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03629756

Combination Immunotherapy for Patients with Advanced Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of AB928 when it is used in combination with AB122.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB928, by mouth</li> <li class="seamTextUnorderedListItem">AB122, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB928 is an investigational immunotherapy drug. It is designed to prevent tumor cells from inhibiting immune cells. </li> <li class="seamTextUnorderedListItem">AB122 is an investigational type of immunotherapy called a PD-1 inhibitor. By blocking PD-1, it helps the immune system see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">This study will also enroll patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03629756' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arcusbio.com/pipeline/ab928/' target='_blank'>Drug company information page: AB928</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arcusbio.com/ab122/' target='_blank'>Drug company information page: AB122</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03778931

Elacestrant for ER+ and HER2- Advanced Breast Cancer (EMERALD)

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial Scientific Title

Purpose

To compare the effectiveness of elacestrant to fulvestrant (Faslodex) or an aromatase inhibitor.

Who is this for?

Women and men with locally advanced (some stage III) or metastatic (stage IV) breast cancer that is ER positive and HER2 negative. You must have already been treated with a CDK4/6 inhibitor in combination with fulvestrant (Faslodex) or an aromatase inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant, by mouth, daily, ongoing </li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy chosen by your doctor: Anastrozole (Armidex®), Letrozole (Femara®), Exemestane (Aromasin®), or Fulvestrant (Faslodex®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an investigational hormone therapy. </li> <li class="seamTextUnorderedListItem">It is expected to work in a similar way to fulvestrant, but is given once a day my mouth rather than by monthly injections. </li> <li class="seamTextUnorderedListItem">The study will also look at the effectiveness of elacestrant compared to other drugs in women and men with ER-positive breast cancer including those whose tumors have mutations in the ESR1 gene.</li> <li class="seamTextUnorderedListItem">Faslodex and aromatase inhibitors are used to treat metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03778931' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/hematology-oncology/breast-cancer/news/online/%7B33085c45-4dcc-46b9-8083-f211dfd03ff5%7D/fda-grants-fast-track-designation-to-elacestrant-for-breast-cancer-subtype' target='_blank'>Healio: FDA grants fast track designation to elacestrant for breast cancer subtype</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/4_Supplement/P4-04-17#' target='_blank'>AACR: Elacestrant (RAD1901) demonstrates anti-tumor activity in a fulvestrant-resistant PDX model</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/radius-health-cmo-has-hope-for-breast-cancer-assets-elacestrant-and-rad140/' target='_blank'>BioSpace: Radius Health CMO Has Hope for Breast Cancer Assets Elacestrant and RAD140</a> </li></ul>

NEAREST SITE: 339 miles
Novartis Investigative Site
Los Angeles,CA

VISITS: Number of visits unavailable, ongoing

PHASE: I

NCT ID: NCT01351103

LGK974 for Metastatic Lobular Breast Cancer

A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Melanoma and Lobular Breast Cancer Scientific Title

Purpose

To determine the safety, best dose, and effectiveness of LGK974 when it is given to individuals with metastatic lobular breast cancer for whom there are no standard treatment options.

Who is this for?

Women and men, with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer and for whom no effective treatment is available. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LGK974</li> </ul> Note: Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are looking for new ways to treat metastatic lobular breast cancer. </li> <li class="seamTextUnorderedListItem">The Wnt pathway is a network of proteins that may play a role in how cancer develops. </li> <li class="seamTextUnorderedListItem">LGK974 is an experimental drug that is designed to inhibit the Wnt pathway.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01351103' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.nature.com/nature/journal/v434/n7035/full/nature03319.html' target='_blank'>Nature Article</a> </li></ul>

NEAREST SITE: 339 miles
UCLA
Santa Monica,CA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I

NCT ID: NCT02637531

IPI-549 and Nivolumab in Advanced Triple Negative Breast Cancer

A Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination With Nivolumab in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of IPI-549 when it is used in combination with nivolumab (Opdivo®).

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has been treated with chemotherapy but not an anti-PD-1 or anti-PD-L1 immunotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IPI-549, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">2 biopsies (pre-treatment and while on treatment)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a PD-1 (programmed cell death-1) inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PD-1 helps immune cells see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is approved to treat at least eight types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">IPI-549 is an investigational targeted therapy that blocks an enzyme called PI3K, which plays a role in cancer cell growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02637531' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.3013' target='_blank'>Journal of Clinical Oncology: Initial results from first-in-human study of IPI-549</a> </li></ul>

100

NEAREST SITE: 339 miles
Novartis Investigative Site
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02890069

Immunotherapy Plus a Targeted Drug for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589) Scientific Title

Purpose

To look at whether a new checkpoint inhibitor, a type of immunotherapy drug, is safe and effective when given along with a targeted drug.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. (ER-, PR, HER2-) Your cancer must have progressed on or not responded to available therapies. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PDR001 and LCL161</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PDR001 and everolimus (Afinitor®)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PDR001 and Panobinostat (LBH589)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is called PDR001. </li> <li class="seamTextUnorderedListItem">You will receive one of three targeted drugs: LCL161, everolimus (Afinitor®), or panobinostat (LBH589).</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02890069' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2016-01890' target='_blank'>Cancer.gov Trial Information</a> </li></ul>

101

NEAREST SITE: 339 miles
University of California Los Angeles
Santa Monica,CA

VISITS: 1 visit every week, ongoing

PHASE: I

NCT ID: NCT03099174

Xentuzumab & Abemaciclib & an Anti-Estrogen Drug for Advanced Breast Cancer

An Open Label, Phase Ib Dose-escalation Study Evaluating the Safety and Tolerability of BI 836845 and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive Breast Cancer, Followed by Expansion Cohorts Scientific Title

Purpose

To identify the best dose, safety and effectiveness of two new targeted drugs. The drugs will be given along with an ant-estrogen drug.

Who is this for?

Women (postmenopausal) and men with advanced (some stage III) or metastatic (stage IV) breast cancer. You must be estrogen receptor positive and HER2 negative. Up to 2 prior regimens of chemotherapy for metastatic disease is allowed. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Xentuzumab (BI 836845), by IV, weekly, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (LY2835219), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Hormone therapy (letrozole/Femara®, anastrozole/Arimidex®, or fulvestrant/Faslodex®), by mouth or injection, daily or monthly, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two new targeted drugs are xentuzumab (BI 836845) and abemaciclib (LY2835219). </li> <li class="seamTextUnorderedListItem">The anti-estrogen drug you are given will be letrozole (Femara®), anastrozole (Arimidex®) or fulvestrant (Faslodex®).</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03099174' target='_blank'>ClinicalTrials.gov</a> </li></ul>

102

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03126110

INCAGN01876 plus Immunotherapies in Advanced Triple Negative Breast (and Other) Cancer

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies Scientific Title

Purpose

To learn about the safety and effects (good and bad) of using INCAGN01876, a new immunotherapy drug, along with one or two approved immunotherapy drugs.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-/PR-/HER2-). Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCAGN01876 and nivolumab (Opdivo®), by IV </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCAGN01876 and ipilimumab (Yervoy®), by IV </li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCAGN01876, nivolumab (Opdivo®), and ipilimumab (Yervoy®), by IV </li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The new immunotherapy drug is called INCAGN01876. </li> <li class="seamTextUnorderedListItem">The two FDA-approved immunotherapy drugs are nivolumab (Opdivo®) and ipilimumab (Yervoy®). These drugs are approved to treat certain types of cancers, but not breast cancer.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03126110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/ipilimumab' target='_blank'>NCI: Yervoy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/nivolumab' target='_blank'>NCI: Opdivo</a> </li></ul>

103

NEAREST SITE: 339 miles
University of California Los Angeles (UCLA)
Santa Monica,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03330561

PRS-343 in HER2-Positive Advanced Breast Cancer

A Phase 1, Open-Label, Dose Escalation Study of PRS-343 in Patients With HER2-Positive Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To test the safety and effects (good and bad) of PRS-343, an experimental cancer drug.

Who is this for?

Women and men with HER2-positive locally advanced (stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRS-343 by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRS-343 is a new type of cancer treatment. </li> <li class="seamTextUnorderedListItem">The drug is a HER2-targeted therapy that also stimulates the immune system. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03330561' target='_blank'>ClinicalTrials.gov</a> </li></ul>

104

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03523572

DS-8201a Plus Immunotherapy for HER2 Positive or HER2 Low Expression Advanced Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer Scientific Title

Purpose

To test the safety and effects (good and bad) of an experimental drug called DS-8201 when it is given along with an immunotherapy to treat advanced breast cancer.

Who is this for?

Women and men with HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-8201a (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03523572' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li></ul>

105

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

VISITS: 1 visit every 2 or 4 weeks

PHASE: I

NCT ID: NCT03538028

Immunotherapy INCAGN02385 in Advanced Triple Negative Breast Cancer

A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies Scientific Title

Purpose

To test the safety and effects (good and bad) of a new type of immunotherapy called INCAGN02385.

Who is this for?

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

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NCAGN02385, by IV, once every 2 or 4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy, INCAGN02385, gets the immune system to see and go after cancer cells by activating a molecule found on T cells called LAG-3. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03538028' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/78/13_Supplement/3819' target='_blank'>Cancer Research Abstract: INCAGN02385</a> </li></ul>

106

NEAREST SITE: 339 miles
Principal Investigator
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03628677

Immunotherapy with AB154 or AB154 and AB122 in Advanced Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies Scientific Title

Purpose

To compare the safety and effects (good and bad) of using the immunotherapy drug AB154 alone with using it in combination with the immunotherapy drug AB122.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer that can not be treated with any standard therapies. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB154</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB154</li> <li class="seamTextUnorderedListItem">AB122</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB154 is an investigational drug that stimulates the immune system by blocking a checkpoint called TIGIT. </li> <li class="seamTextUnorderedListItem">AB122 is an investigational immunotherapy that gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03628677' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/immune-checkpoint-inhibitors.html' target='_blank'>American Cancer Society: Immune checkpoint inhibitors to treat cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arcusbio.com/ab154/' target='_blank'>Drug Company Information Page: AB154</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arcusbio.com/ab122/' target='_blank'>Drug Company Information Page: AB122</a> </li></ul>

107

NEAREST SITE: 339 miles
UCLA Health
Santa Monica,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03650348

PRS-343 With Tecentriq in HER2 Positive Advanced Breast Cancer

A Phase 1b, Open-Label, Dose Escalation Study of PRS-343 in Combination With Atezolizumab in Patients With HER2-Positive Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To determine the best dose, safety and effects (good and bad) of PRS-343 when it is given along with atezolizumab (Tecentriq®).

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer and have been treated with at least one systemic therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRS-343, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRS-343 is a new type of HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat advanced triple-negative breast cancer, when used along with paclitaxel, in patients whose tumor tests positive for PD-L1.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03650348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>Cancer.gov: Atezolizumab Approved for Some Patients with Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/791831' target='_blank'>NCI Drug Dictionary: Anti-HER2 monoclonal antibody/anti-CD137 anticalin bispecific fusion protein PRS-343</a> </li></ul>

108

NEAREST SITE: 339 miles
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03674567

Immunotherapy for Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475 is an investigational targeted therapy that helps the immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03674567' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.flxbio.com/next-generation-immune-modulators/flx475/' target='_blank'>Sponsor site: FLX475</a> </li></ul>

109

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT02926911

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

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

Purpose

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

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups and undergo the following: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery with or without radiation</li> <li class="seamTextUnorderedListItem">followed by mammogram, every 12 months for 5 years</li> <li class="seamTextUnorderedListItem">Optional endocrine therapy for 5 years</li> </ul> Group 2: Active Monitoring <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram, every 6 months for 5 years</li> <li class="seamTextUnorderedListItem">Optional endocrine therapy for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Not all DCIS will become invasive breast cancer. This means that some women being treated for DCIS are getting more treatment than is necessary. </li> <li class="seamTextUnorderedListItem">The standard of care is surgery, which may be followed by radiation and/or anti-estrogen treatment.</li> <li class="seamTextUnorderedListItem">For more information, email: thomas.lynch2@duke.edu</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02926911' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://dcisoptions.org/' target='_blank'>COMET study website</a> </li><li class='seamTextUnorderedListItem'><a href='https://am.asco.org/when-less-more-breast-cancer-treatment' target='_blank'>ASCO: When 'Less is More' in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pcori.org/research-results/2015/comparing-benefits-and-harms-watchful-waiting-versus-standard-treatment-women' target='_blank'>PCORI: Study information</a> </li></ul>

110

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

VISITS: Coincides with type of therapy

PHASE: NA

NCT ID: NCT03098576

Genetic Tumor Profiling to Select Targeted Drug to Treat Advanced Breast Cancer

A Basket Study: Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute Scientific Title

Purpose

To determine which targeted drug could be used as a treatment for your cancer.

Who is this for?

Women and men with advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have had at least one treatment your tumor did not respond to or progressed on. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on the results of your molecular profiling: Group 1: Matched targeted drug treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive a drug that is targeted to a specific genetic abnormality (mutation) if a mutation is found</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive the standard of care therapy if no mutation is found</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Molecular profiling is a process that identifies mutations and biomarkers in your tumor's DNA that have FDA-approved matched therapies or are eligible for clinical studies.</li> <li class="seamTextUnorderedListItem">In this study, a sample of your tumor will be analyzed (called molecular profiling) at Cedars-Sinai Medical Center in California.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03098576' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancercenter.com/treatments/tumor-molecular-profiling/' target='_blank'>Cancer Treatment Center of America: Tumor Molecular Profiling</a> </li></ul>

111

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

VISITS: Visits every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03310957

SGN-LIV1A and Keytruda for Advanced Triple Negative Breast Cancer

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

Purpose

To look at the safety and effects (good and bad) of using SGN-LIV1A along with pembrolizumab (Keytruda®) to treat triple negative advanced or metastatic breast cancer.

Who is this for?

Women and men with advanced (some stage III) and metastatic (stage IV) breast cancer that is triple negative. You may not have received prior treatment for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A is an investigational drug that targets a protein called LIV-1 that is found on some tumor cells. </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda® is approved to treat certain types of cancer, including breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03310957' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/20659' target='_blank'>ASCO Post: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://investor.seattlegenetics.com/phoenix.zhtml?c=124860&p=irol-newsArticle&ID=2305936' target='_blank'>Seattle Genetics: SGN-LIV1A</a> </li></ul>

112

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 or Stage III 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 effect that giving pembrolizumab (Keytruda®) and radiation therapy before surgery have on the breast tumor.

Who is this for?

Women with stage II or stage III ER-positive and HER2-negative or triple negative (ER-/PR-/HER2-) breast cancer who will have 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">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>

113

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 early stage (stage I, II or IIIa) triple negative (ER-, PR- and 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>

114

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03659136

Xentuzumab With Everolimus and Exemestane in HR Positive and HER2 Negative Advanced Breast Cancer

XENERA™-1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Post-menopausal Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease Scientific Title

Purpose

To compare the effects (good and bad) of the combination of xentuzamab, everolimus (Afinitor®), and exemestane (Aromasin®) to the combination of a placebo, Afinitor and Aromasin.

Who is this for?

Postmenopausal women with HR positive HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Xentuzumab, by IV</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), by mouth</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Xentuzumab is an investigational targeted therapy that blocks insulin-like growth factor (IGF). </li> <li class="seamTextUnorderedListItem">Studies suggest it may improve how cancer cells respond to chemotherapy. </li> <li class="seamTextUnorderedListItem">Aromasin is an anti-estrogen drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Afinitor is a chemotherapy drug used to treat advanced HR positive 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/NCT03659136' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/drugs/2/drug-17764/exemestane-oral/details' target='_blank'>WebMD: Exemestane</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/everolimus' target='_blank'>Cancer Research UK: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/xentuzumab' target='_blank'>NCI Drug Dictionary: Xentuzumab</a> </li></ul>

115

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

VISITS: Weekly visits for 3 months

PHASE: II

NCT ID: NCT03747120

Chemotherapy, Her2 Targeted Therapy & Immunotherapy Before Surgery in HER2+ Breast Cancer

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

Purpose

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

Who is this for?

Women and men with HER2 positive stage I, II or III breast cancer and have not yet received any treatment for breast cancer. Full eligibility criteria

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

116

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

VISITS: Please contact research site

PHASE: I

NCT ID: NCT03775525

GZ17-6.02 for Metastatic Breast Cancer (GEN602)

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Given Orally on a Daily x 28 Day Schedule in Patients With Advanced Solid Tumors or Lymphoma Scientific Title

Purpose

To study the safety and effects (good and bad) of a new type of cancer drug called GZ17-6.02.

Who is this for?

Women and men with metastatic (stage IV) breast cancer who have no other available standard treatment options. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GZ17-6.02, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers have found that GZ17-6.02 blocks the super-enhancers that send signals for cells to grow. </li> <li class="seamTextUnorderedListItem">This study is also enrolling women with advanced endometrial cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03775525' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mct.aacrjournals.org/content/17/1_Supplement/LB-A26' target='_blank'>AACR Abstract: GZ17-6.02</a> </li></ul>

117

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

VISITS: Weekly visits for 4 months

PHASE: I

NCT ID: NCT02626507

Gedatolisib, Ibrance and Faslodex Before Surgery in Women With ER+ HER2- Breast Cancer

Phase I Dose-Escalation Study of Combination of Gedatolisib (a Dual Inhibitor of PI3-K and mTOR) With Palbociclib and Faslodex in the Neoadjuvant Setting in Previously Untreated Patients With ER+/HER2- Breast Cancer Scientific Title

Purpose

To test the safety and effects (good and bad) and best dose of the targeted therapy gedatolisib when used along with fulvestrant (Faslodex®) and palbociclib (Ibrance®).

Who is this for?

Women with ER-positive HER2-negative stage I, II, III or IV (metastatic) breast cancer who has not yet had any breast cancer treatments and is scheduled to have a lumpectomy or a mastectomy. Full eligibility criteria

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You will receive the following treatment before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, once a week for 4 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, twice a month in the first month, then monthly for the remaining 3 months</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily for 3 weeks each month</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by mouth, once a month, if needed</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The purpose of this study is to test the safety and effects (good or bad) and best dose of the targeted therapy gedatolisib when used along with fulvestrant (Faslodex®) and palbociclib (Ibrance®). </li> <li class="seamTextUnorderedListItem">The combination is given before surgery. This is called neoadjuvant treatment. </li> <li class="seamTextUnorderedListItem">Giving therapy before surgery allows researchers to study the effect the therapy has on the breast tumor. </li> <li class="seamTextUnorderedListItem">Gedatolisib kills cancer cells by blocking the PI3K/mTOR pathway. </li> <li class="seamTextUnorderedListItem">Faslodex® is a hormone therapy approved to treat advanced breast cancer in postmenopausal women. </li> <li class="seamTextUnorderedListItem">Ibrance® is a type of targeted therapy called a CDK 4/6 inhibitor. It is approved to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">If you are premenopausal, you will also be given the drug goserelin (Zoladex®), which will put you in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02626507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancer-news.com/2017/11/15/advanced-breast-cancer-therapy-combo-faslodex-fulvestrant-ibrance-palbociclib-approved-eu/' target='_blank'>Breast Cancer News: European Commission Approves Faslodex-Ibrance Combo for Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/palbociclib' target='_blank'>NCI Drug dictionary: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/fulvestrant' target='_blank'>NCI Drug dictionary: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/goserelinacetate' target='_blank'>NCI Drug dictionary: Goserelin (Zoladex®)</a> </li></ul>

118

NEAREST SITE: 347 miles
City of Hope South Pasadena
South Pasadena,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT01905046

Metformin to Reduce Breast Cancer Risk in Women with Increased Risk of Developing Breast Cancer

Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology After 12 Months Metformin (1,1-Dimethylbiguanide Hydrochloride) Chemoprevention Versus Placebo Control in Premenopausal Women Scientific Title

Purpose

To determine whether metformin is better than a placebo at reducing breast cancer risk.

Who is this for?

Women who are at increased risk of breast cancer due to family history, BRCA mutation, or breast changes including atypical hyperplasia, DCIS or LCIS. Full eligibility criteria

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All participants will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Metformin, by mouth, daily for 2 years</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily for 1 year (may crossover to Group 1 for 1 year)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Women who have been diagnosed with atypical hyperplasia, DCIS or LCIS are at increased risk of developing breast cancer. </li> <li class="seamTextUnorderedListItem">Researchers are trying to find drugs (chemoprevention) that can reduce this risk. </li> <li class="seamTextUnorderedListItem">Findings from previous studies suggest that metformin, a drug used to treat diabetes, can reduce breast cancer risk in high-risk women.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01905046' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/about-cancer/causes-prevention/research/metformin' target='_blank'>NCI: Metformin Help Prevent Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/navigating-cancer-care/prevention-and-healthy-living/chemoprevention' target='_blank'>Cancer.net: Chemoprevention</a> </li></ul>

119

NEAREST SITE: 347 miles
South Pasadena Cancer Center
South Pasadena,CA

VISITS: 2 visits

PHASE: NA

NCT ID: NCT01992432

Studying the Effect of Chemotherapy on the Brain in Older Women

A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer Scientific Title

Purpose

To study how advanced MRI techniques characterize the changes that occur in the brain.

Who is this for?

Women age 65 and older receiving adjuvant chemotherapy. Full eligibility criteria

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All participants undergo: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain fMRI (functional MRI) before and after chemotherapy</li> <li class="seamTextUnorderedListItem">Cognitive testing before and after chemotherapy</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01992432' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://breakthroughs.cityofhope.org/chemo-brain-questions-cancer' target='_blank'>City of Hope: Chemo Brain</a> </li></ul>

120

NEAREST SITE: 347 miles
Chan Soon-Shiong Institute for Medicine
El Segundo,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03552718

Personalized Vaccine After Completing Treatment for Breast Cancer

QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers. (QUILT-2.025) Scientific Title

Purpose

To test the safety, effects (good and bad) and best dose of an immunotherapy vaccine that can be personalized to each patient's tumor profile.

Who is this for?

Women and men who have completed treatment for stage I, stage II or stage III breast cancer. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">YE-NEO-001, by injection</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">YE-NEO-001 is a personalized vaccine. It is produced based on an individual's tumor profile.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03552718' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/797413' target='_blank'>NCI Drug Dictionary: Personalized neoepitope yeast vaccine YE-NEO-001</a> </li></ul>

121

NEAREST SITE: 348 miles
University of Southern California Keck School of Medicine
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT01670877

Neratinib For HER2-Negative Metastatic Breast Cancer

A Phase II Study of Neratinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer Scientific Title

Purpose

To see if neratinib is effective in patients with HER2- tumors that test positive for the HER2 genetic mutation.

Who is this for?

Women and men metastatic (stage IV) breast cancer that is HER2 negative. Your tumor can be estrogen receptor positive or negative. Full eligibility criteria

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All participants will receive the following treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib by mouth daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer tumors are tested to determine whether they are producing too many HER2 proteins. Those that do are called HER2-positive; those that don't are HER2-negative. </li> <li class="seamTextUnorderedListItem">Using a new type of test, researchers can determine whether a HER2-negative tumor has a HER2 mutation in its DNA. It is possible that HER2-negative tumors with a HER2 genetic mutation will respond to drugs used to treat HER2-positive tumors. </li> <li class="seamTextUnorderedListItem">Neratinib is type of new cancer drug called a tyrosine kinase inhibitor. It works by blocking the HER2 and the EGFR pathways. Neratinib has been studied in patients with HER2+ tumors. </li> <li class="seamTextUnorderedListItem">Patients who meet the criteria for this study will have their tumor tested for the HER2 mutation. Only those who are found to have a HER2 mutation will be able to take part in the study.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01670877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/publications/obtn/2013/January-2013/HER2-Mutations-Identified-as-Treatment-Targets-in-Patients-With-HER2-Negative-Breast-Cancer' target='_blank'>OncLive: HER2 Mutations article</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.aacr.org/home/public--media/aacr-in-the-news.aspx?d=3000' target='_blank'>AACR: News</a> </li></ul>

122

NEAREST SITE: 348 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: 1 visit

PHASE: NA

NCT ID: NCT01755208

Using Light-Scattering Spectroscopy to Analyze Breast Tissue

Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study Scientific Title

Purpose

To investigate whether light-scattering spectroscopy can differentiate between women who have stage II or III breast cancer and women who do not have breast cancer.

Who is this for?

Women with stage II or stage III breast cancer, or without breast cancer, scheduled to have a mammogram at the University of Southern California. Full eligibility criteria

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All participants will receive the following procedure: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Light-scattering spectroscopy in addition to standard of care</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A doctor will perform a breast biopsy to learn more about an area of concern seen on a mammogram. </li> <li class="seamTextUnorderedListItem">Light-scattering spectroscopy (LSS) is an imaging technique that does not require removal of tissue samples and can provide quick results. </li> <li class="seamTextUnorderedListItem">LSS may be able to identify cell abnormalities more effectively than a biopsy.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01755208' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ncbi.nlm.nih.gov/pubmed/17280544' target='_blank'>PubMed: Light spectroscopy for early cancer detection</a> </li></ul>

123

NEAREST SITE: 348 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT01802346

Low-Calorie Diet To Reduce Side Effects of Chemotherapy

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy Scientific Title

Purpose

To study whether patients with breast cancer who eat a controlled low-calorie diet will have fewer side effects and a better response to chemotherapy than patients who eat a normal diet. (This trial also is enrolling men with prostate cancer.)

Who is this for?

Women and men with breast cancer 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">Eat a special low-calorie diet during before, during and after chemotherapy (All food provided)</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eat a normal diet, receive dietary advice from a nutritionist</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy drugs attack cells that are rapidly dividing, which is why they are an effective cancer treatment. </li> <li class="seamTextUnorderedListItem">However, other cells in the body that also divide rapidly, like those in the bone marrow, mouth, intestines, and hair follicles, are also likely to be affected by chemotherapy®which can lead to side effects. </li> <li class="seamTextUnorderedListItem">It is possible that eating a low-calorie diet may reduce chemotherapy-related side effects as well as improve how the tumor responds to treatment.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01802346' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/chemotherapy/side_effects' target='_blank'>BreastCancer.org: Chemotherapy Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-chemotherapy' target='_blank'>Cancer.gov: Chemotherapy</a> </li></ul>

124

NEAREST SITE: 348 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02264678

AZD6738 with Chemotherapy and/or Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies. Scientific Title

Purpose

To study the safety, effects, and best dose of AZD6738 when it is used alone or with the chemotherapy drug carboplatin or the PARP inhibitor olaparib (Lynparza®).

Who is this for?

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

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

You will be assigned to 1 of 3 groups: Group 1: Open to all MBC patients <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738, by mouth </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 4.5 months</li> </ul> Group 2: Open to all MBC patients <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738, by mouth</li> </ul> Group 3: Open to Triple Negative Breast Cancer MBC patients with or without a BRCA mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 biopsies (at baseline, last day of dosing and following progression of disease)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6738 is a new type of targeted therapy called an ATR inhibitor. </li> <li class="seamTextUnorderedListItem">It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. </li> <li class="seamTextUnorderedListItem">Carboplatin is a chemotherapy drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor approved to treat BRCA positive metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02264678' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: AZD6738</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/olaparib' target='_blank'>NCI Drug Dictionary: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/targeting-cancers-achilles-heel-dna-damage-response-networks-beyond-parp' target='_blank'>OncLive: DNA Damage Response Networks Beyond PARP</a> </li></ul>

125

NEAREST SITE: 348 miles
USC / Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: 3 visits a week for 12 weeks

PHASE: NA

NCT ID: NCT02454777

High-Intensity Interval Training for Patients with Early-Stage Breast Cancer

High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use Scientific Title

Purpose

To determine if women receiving chemotherapy and Herceptin can take part in high-intensity interval training to improve their heart and overall health.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who are planning to receive trastuzumab (Herceptin®) and chemotherapy. You must speak English and/or Spanish and be between the ages of 30 and 60. Full eligibility criteria