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

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(Last updated: May 21, 2020)

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NEAREST SITE: 3 miles
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
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?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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
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?

People 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
University of California San Francisco Medical Center
San Francisco,CA

VISITS: 4 visits over 2 months

PHASE: I

NCT ID: NCT03517488

XmAb20717 Immunotherapy for Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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

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

VISITS: 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?

People 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: 3 miles
UCSF Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03454451

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

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

Purpose

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

Who is this for?

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

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">CPI-444, by mouth, twice daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006 is an investigational immunotherapy that gets the immune system to after cancer cells by targeting CD73. </li> <li class="seamTextUnorderedListItem">CPI-444 is an investigational immunotherapy that targets the adenosine-A2A receptor (ADORA2A) on immune cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03454451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.2505' target='_blank'>Journal of Clinical Oncology: CPI-006, an anti-CD73 antibody with immune modulating activity, in a phase 1 trial in advanced cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/adenosine-a2a-receptor-antagonist-cpi-444' target='_blank'>NCI Drug Dictionary: adenosine-A2A receptor antagonist CPI-444</a> </li></ul>

NEAREST SITE: 3 miles
University of California 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 conjugates (ADCs) are cancer therapies that combine 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
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?

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

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

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

Sacituzumab Govitecan in Advanced Hormone Positive, HER2 Negative 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 sacituzumab govitecan to standard of care chemotherapy.

Who is this for?

People with metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has already been treated with 2 to 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 approved for use in some people with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer.</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 TROP2 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.cancer.org/latest-news/fda-approves-trodelvy-sacituzumab-govitecan-hziy-for-triple-negative-breast-cancer.html' target='_blank'>American Cancer Society: FDA Approves Trodelvy (Sacituzumab Govitecan-Hziy) for Triple Negative Breast Cancer</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
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?

People 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
UCSF ( Site 0015)
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?

People 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: 8 miles
Kaiser Permanente - South San Francisco
South 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?

People 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> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA, AKT1, or PTEN</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: 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?

People 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
Exelixis Clinical Site #21
Stanford,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03170960

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy 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 Hospital and Clinics
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03330405

Avelumab Plus Talazoparib For Advanced, Triple Negative or Hormone Positive 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 study the safety and effects (good and bad) of using an immunotherapy agent along with a targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+) breast cancer. 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 (Talzenna®)</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 (Talzenna®) 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><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29063313' target='_blank'>PubMed: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com' target='_blank'>Pfizer Oncology Information Page: Talazoparib</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02401347

Talazoparib for Advanced, HER2 Negative 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 (Talzenna®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is HER2 negative (HER2-), but not BRCA positive. You must have had at least one prior 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 (Talzenna®), 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 (Talzenna®) is a PARP inhibitor that is approved to treat people with advanced or metastatic, HER2 negative (HER2-) breast cancer and an inherited BRCA 1 or BRCA 2 mutation. </li> <li class="seamTextUnorderedListItem">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><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com' target='_blank'>Pfizer Oncology Information Page: Talazoparib</a> </li></ul>

NEAREST SITE: 27 miles
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?

People 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: 28 miles
Stanford University Medical Center
Palo Alto,CA

VISITS: 4 visits every 6 weeks for 2 years

PHASE: II

NCT ID: NCT03567720

Tavo & Pembrolizumab (Immunotherapy) in Advanced Triple Negative Tumors

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

Purpose

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

Who is this for?

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

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

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03621982

ADCT-301 in 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®-TACâ„¢ with a new type of chemotherapy drug called PBD.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301, by IV, 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®-TACâ„¢ 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: 53 miles
St. Joseph Heritage Healthcare ( Site 0104)
Santa Rosa,CA

VISITS: At least 3 visits a month, ongoing

PHASE: II-III

NCT ID: NCT04191135

Carboplatin, Keytruda®, & Gemcitabine With or Without Lynparza® in Advanced Triple Negative Breast Cancer

An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009) Scientific Title

Purpose

To study the safety and effects (good and bad) of adding olaparib (Lynparza®) to the treatment combination carboplatin (Paraplatin®), gemcitabine (Gemzar®), and pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not started treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly (2 weeks on, 1 week off), for 3 to 5 months</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly (2 weeks on, 1 week off), for 3 to 5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 3 to 5 months</li> </ul> Then you will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, weekly (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). </li> <li class="seamTextUnorderedListItem">It is approved to treat HER2-negative metastatic breast cancer in women with a hereditary BRCA genetic mutation. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug routinely used to treat advanced and metastatic triple negative breast cancer. </li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®)is a chemotherapy drug used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PDL-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/NCT04191135' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/breast-cancer/breast-cancer-types/triple-negative.html' target='_blank'>AstraZeneca Information Page: Lynparza® (Olaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/carboplatin' target='_blank'>Breast Cancer Now: Carboplatin</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Gemcitabine' target='_blank'>Wikipedia: Gemcitabine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology: Keytruda®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/publications/cure/2019/immunotherapy-2019/breast-cancer-gets-a-boost-from-immunotherapy' target='_blank'>Cure Today: Breast Cancer Gets a Boost From Immunotherapy</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, for 2 years

PHASE: I-II

NCT ID: NCT03761914

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

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

Purpose

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

Who is this for?

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

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What's being studied?
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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
University of California Davis Comprehensive Cancer Center
Sacramento,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?

People 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: 86 miles
Pacific Cancer Care
Monterey,CA

VISITS: 3 visits per month, ongoing

PHASE: II

NCT ID: NCT03961698

IPI-549, Tecentriq® and Abraxane® for Advanced Triple-Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 336 miles
Ronald Reagan UCLA Medical Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03674827

A Vaccine-Based Immunotherapy For Stage IV Triple Negative Breast Cancer

A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Escalating Doses And Treatment Intensification Of A Vaccine-based Immunotherapy Regimen-2 (Vbir-2) (Pf-06936308) For Advanced Non-small Cell Lung Cancer And Metastatic Triple-negative Breast Cancer Scientific Title

Purpose

To investigate the safety and effects (good and bad) of increasing doses of a vaccine-based immunotherapy called TPF-06936308.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06936308, 4 times every 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The vaccine (TPF-06936308) is designed to make immune cells find and then stop the growth of cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with advanced 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/NCT03674827' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795350' target='_blank'>Cancer.gov: Adenoviral cancer vaccine PF-06936308</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/what-are-cancer-vaccines' target='_blank'>Cancer.net: What are Cancer Vaccines?</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03401385

DS-1062a in Advanced Triple Negative Breast Cancer

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of DS-1062a.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a</li> <li class="seamTextUnorderedListItem">2 biopsies</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a is an investigational antibody-drug conjugate (ADC). This type of drug uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets Trop-2 proteins. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03401385' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793720' target='_blank'>NCI Drug Dictionary: DS-1062a</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03849469

XmAb®22841 and Pembrolizumab in Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®22841</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®22841</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb22841 is a new type of immunotherapy that targets CTLA-4 and LAG-3. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to certain types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03849469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.xencor.com/pipeline/' target='_blank'>Drug company information page: XmAb®22841</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/latest-news/fda-approves-keytruda-pembrolizumab-for-any-tumor-with-specific-genetic-change.html' target='_blank'>Cancer.org: FDA Approves Keytruda (Pembrolizumab) for Any Tumor with Specific Genetic Change</a> </li></ul>

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?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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: 338 miles
Research site
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04293094

AMG 650 for People With Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive the following: AMG 650, by mouth, ongoing
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04293094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

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?

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

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03674567

Immunotherapy for Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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What's being studied?
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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>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03665285

NC318 for Advanced Triple-Negative Breast Cancer

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

Purpose

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

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer that has low levels of the protein PD-L1 and have no standard treatment options. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NC318, by injection</li> </ul> Please contact research site for treatment schedule Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 or 2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NC318 is designed to block a protein, called S15, that keeps the immune system from killing cancer cells. </li> <li class="seamTextUnorderedListItem">Blocking this protein could help the immune system see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03665285' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796496' target='_blank'>NCI Drug Dictionary: NC318</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.nextcure.com/pipeline/' target='_blank'>Drug Company Information Page: NC318</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808' target='_blank'>Mayo Clinic: Monoclonal Antibody Drugs for Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2018/03/monoclonal-antibody-therapy-cancer/' target='_blank'>Dana-Farber Cancer Institute: What is Monoclonal Antibody Therapy for Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/keytruda-faq/what-are-pd1-and-pdl1/' target='_blank'>Merk Oncology: What are PD-1 and PD-L1?</a> </li></ul>

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?

People 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>

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?

People 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>

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?

People 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>

NEAREST SITE: 339 miles
UCLA School of Medicine
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?

People, 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 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?

People 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>

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?

People 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>

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?

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

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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>

NEAREST SITE: 353 miles
City Of Hope National Medical Center
Duarte,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02419417

BMS-986158 for Advanced Triple Negative Breast (and Other) Cancer

A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Advanced Solid Tumors Scientific Title

Purpose

To investigate whether a new targeted drug for triple negative breast cancer is safe and effective.

Who is this for?

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

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You will receive the following at increasing does until the maximum tolerated dose is reached: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986158, by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The new drug being studied is called BMS-986158. It is currently only available in clinical trials. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02419417' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: 2 visits every 3 weeks, ongoing

PHASE: I

NCT ID: NCT02996825

Mirvetuximab Soravtansine & Chemotherapy in FRa+ Metastatic Triple Negative Breast Cancer

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To test the safety and effects (good and bad) of a new drug called mirvetuximab soravtansine when it is given with the chemotherapy drug gemcitabine (Gemzar®).

Who is this for?

People with stage IV metastatic breast cancer that is triple negative (ER-, PR- and HER2-) and folate receptor (FR) alpha-positive. You must not have had more than four lines of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mirvetuximab soravtansine, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine/Gemzar®, by IV, twice every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mirvetuximab soravtansine is an antibody drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">It uses a drug that targets folate receptors on cancer cells to deliver the chemotherapy drug soravtansine directly to the tumor. </li> <li class="seamTextUnorderedListItem">Gemzar® is a chemotherapy drug approved to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of FR+ tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02996825' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mirvetuximab-soravtansine' target='_blank'>NCI Dictionary: Mirvetuximab Soravtansine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/gemcitabine-hydrochloride' target='_blank'>NCI Dictionary: Gemcitabine Hydrochloride</a> </li></ul>

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

VISITS: 2-3 visits every month, ongoing

PHASE: I-II

NCT ID: NCT03853707

Ipatasertib, Carboplatin and Paclitaxel in Metastatic Triple Negative Breast Cancer

A Phase I/IB Study of Ipatasertib in Combination With Carboplatin or Carboplatin/Paclitaxel in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To determine the best dose of ipatasertib (GDC-0068) when it is used along with paraplatin (Carboplatin®) alone or with paraplatin (Carboplatin®) and paclitaxel (Taxol®).

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1: With Paclitaxel <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, once daily, ongoing</li> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, 2 or 3 times a month, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, 2 or 3 times a month, ongoing</li> </ul> Group 2: Without Paclitaxel <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, once daily, ongoing</li> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, 2 or 3 times a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells grow and divide. </li> <li class="seamTextUnorderedListItem">Carboplatin and Taxol are chemotherapy drugs 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/NCT03853707' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/News/57955' target='_blank'>ASCO Post: AKT Inhibitor Ipatasertib in Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2018/data-support-phase-3-trial-with-akt-inhibitor-in-triple-negative-breast-cancer' target='_blank'>OncLive: Early OS Data Support Phase III Trial With AKT Inhibitor Ipatasertib for TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdz133/5485241' target='_blank'>Annals of Oncology: Targeting the PI3-kinase pathway in triple-negative breast cancer</a> </li></ul>

NEAREST SITE: 359 miles
Research Site
Whittier,CA

VISITS: 3 visits a month for at least 6 months

PHASE: III

NCT ID: NCT03997123

Capivasertib & Paclitaxel as First Line Treatment for Advanced Triple Negative Tumors

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC. (CapItello290) Scientific Title

Purpose

To compare the effects (good and bad) and effectiveness of paclitaxel (Taxol®) and capivasertib to paclitaxel (Taxol®) and a placebo.

Who is this for?

People who are receiving their first treatment for advanced (some stage III) or metastatic (stage IV) 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: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, 4 times a week, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on, 1 week off, for at least 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, 4 times a week, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on, 1 week off, for at least 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy drug that blocks Akt.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03997123' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/akt-inhibitor-azd5363' target='_blank'>NCI Drug Dictionary: Capivasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>Oncolive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/80249' target='_blank'>Medpage Today: AKT Inhibitor Doubles PFS in Advanced Breast Cancer</a> </li></ul>

NEAREST SITE: 363 miles
Pacific Shores Medical Group
Long Beach,CA

VISITS: 1 visit weekly

PHASE: I

NCT ID: NCT03800836

Ipatasertib with Atezolizumab & Paclitaxel or Nab-Paclitaxel in Advanced TNBC

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using ipatasertib in combination with atezolizumab (Tecentriq®) and either paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®).

Who is this for?

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

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What's involved?
What's being studied?
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You will be assigned to 1 of 2 groups: Group 1: with Paclitaxel <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 2 weeks </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Group 2: with Nab-Paclitaxel <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 2 weeks </li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells divide and grow. </li> <li class="seamTextUnorderedListItem">Tecentriq is an immunotherapy that is approved for use in combination with Taxol to treat PD-L1-positive advanced triple negative breast cancer. </li> <li class="seamTextUnorderedListItem">Taxol and Abraxane are chemotherapy drugs 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/NCT03800836' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/04/01/mbc-news-10/' target='_blank'>MetastaticTrialTalk: Tecentriq® (Atezolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biooncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Drug information page: Ipatasertib</a> </li></ul>

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

VISITS: At least 1 visit per month

PHASE: II

NCT ID: NCT03207867

Combination Immunotherapies for Advanced Triple Negative Breast Cancer

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

Purpose

To study the safety and effects (good and bad) of using two different types of immunotherapy drugs at the same time to treat advanced triple negative breast cancer.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIR178, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">PDR001, by IV, monthly, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two experimental immunotherapies being used in this study are NIR178 and PRD001.</li> <li class="seamTextUnorderedListItem">NIR178 is an adenosine receptor antagonist. It blocks adenosine, which is found in the microenvironment that surrounds the tumor. </li> <li class="seamTextUnorderedListItem">PDR001 is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03207867' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/understanding-immunotherapy' target='_blank'>Cancer.net: Understanding Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pdr001/' target='_blank'>Immuno-Oncology News: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/news/media-releases/novartis-continues-grow-immuno-oncology-pipeline-through-collaboration-and' target='_blank'>Novartis: NIR178</a> </li></ul>

NEAREST SITE: 421 miles
Las Vegas, NV
Las Vegas,NV

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

PHASE: I

NCT ID: NCT03719326

Immunotherapy Plus Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast and Gynecologic Malignancies Scientific Title

Purpose

To evaluate the best dose, safety and effects (good and bad) of AB928 when it is used along with pegylated liposomal doxorubicin (PLD).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB928, by injection, once a week for 6 weeks, then once every 3 weeks for 2 years </li> <li class="seamTextUnorderedListItem">Pegylated liposomal doxorubicin (DOXIL®), by IV, once every 3 weeks for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB928 is a targeted therapy that researchers think can boost the immune system.</li> <li class="seamTextUnorderedListItem">Pegylated liposomal doxorubicin (Doxil®) 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/NCT03719326' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncolink.org/cancer-treatment/oncolink-rx/doxorubicin-liposomal-doxil-r' target='_blank'>OncoLink: Doxorubicin Liposomal (Doxil®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arcusbio.com/pipeline/ab928/' target='_blank'>Arcus: AB928</a> </li></ul>

NEAREST SITE: 426 miles
Research Site
Palm Springs,CA

VISITS: 5 initial visits, then 1 visit every 2 months for 18 months, then 1 visit every 3 months

PHASE: II

NCT ID: NCT03330847

Lynparza Alone or With a New Drug That Targets DNA Repair in Metastatic TNBC

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant... (VIOLETTE) Scientific Title

Purpose

To compare the safety and effect (good and bad) of using olaparib (Lynparza®) alone to using Lynparza along with a new drug that targets DNA repair.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. You may have had up to two prior treatments for advanced disease and have a genetic mutation that is related to BRCA. 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">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">AZD6738, by mouth, once a day for one week out of every 4 weeks</li> </ul> Group 3: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">AZD1775, by mouth, twice a day for 6 days out of every 3 weeks</li></ul>
Lynparza is a type of drug called a PARP inhibitor. <ul class="seamTextUnorderedList"> <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">The experimental drugs used in this study, AZD6738 and AZD1775, also target DNA damage repair.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03330847' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm592357.htm' target='_blank'>FDA approves olaparib for germline BRCA-mutated metastatic breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/' target='_blank'>Lynparza.com</a> </li></ul>

NEAREST SITE: 441 miles
UC San Diego Moores Cancer Center
San Diego,CA

VISITS: 1 visit every 2 weeks, for 2 months

PHASE: I

NCT ID: NCT03752398

XmAb®23104 for Advanced Triple Negative Breast Cancer (DUET-3)

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad) and the best dose of an experimental immunotherapy called XmAb®23104.

Who is this for?

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

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®23104, by IV, every 2 weeks, for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®23104 targets both PD-1 (programmed cell death protein 1) and ICOS (inducible T-cell co-stimulator). </li> <li class="seamTextUnorderedListItem">This study is enrolling patients with other types of metastatic cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03752398' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796973' target='_blank'>NCI drug dictionary: XmAb23104</a> </li></ul>

NEAREST SITE: 441 miles
University of California San Diego Medical Center; Moores Cancer Center
La Jolla,CA

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03424005

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 441 miles
University of California, San Diego
La Jolla,CA

VISITS: Visits weekly over 6 months

PHASE: I

NCT ID: NCT02776917

A New Targeted Therapy and Taxol for Advanced Breast Cancer

A Phase 1b Pilot Clinical Trial of Cirmtuzumab, an Anti-ROR1 Monoclonal Antibody, in Combination With Paclitaxel for the Treatment of Patients With Metastatic, or Locally Advanced, Unresectable Breast Cancer Scientific Title

Purpose

To investigate the safety and effects (good and bad) of a new type of targeted therapy when it is given along with the chemotherapy drug paclitaxel (Taxol®) to treat advanced breast cancer.

Who is this for?

People with triple negative (ER-, PR-, or HER2-) or hormone receptor positive (ER+ or PR+), 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">Cirmtuzumab, by IV, weekly (2 weeks on, 2 weeks off), over 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, ongoing</li> <li class="seamTextUnorderedListItem">Blood and tissue sample collection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The experimental targeted therapy is cirmtuzumab. It targets ROR1, a protein found only on cancer cells. </li> <li class="seamTextUnorderedListItem">Taxol is commonly used to treat breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02776917' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.ucsd.edu/news/releases/Pages/2018-08-27-researchers-to-test-novel-drug-combination-against-toughest-breast-cancer.aspx' target='_blank'>UCSD Health Article</a> </li></ul>

NEAREST SITE: 455 miles
Kaiser Permanente-SCPMG; Oncology Research
San Diego,CA

VISITS: 3 visits a month, ongoing

PHASE: III

NCT ID: NCT04177108

Paclitaxel Alone or With Ipatasertib and/or Atezolizumab for People with Advanced TNBC

A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer. Scientific Title

Purpose

To look at at the safety and effects (good and bad) of the experimental targeted therapy ipatasertib (GDC-0068) when it is used along with the chemotherapy drug paclitaxel (Taxol®) and the immunotherapy atezolizumab (Tecentriq®).

Who is this for?

People who are starting treatment for advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. Full eligibility criteria

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If your tumor is negative for PD-L1, you will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> If your tumor is positive for PD-L1, you will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib is a type of targeted therapy called an AKT inhibitor. AKT is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Tecentriq® is a type of immunotherapy called a PD-L1 (programmed death-ligand 1) inhibitor. It is approved for use along with Taxol to treat metastatic triple negative breast cancer that 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/NCT04177108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2017/05/what-is-a-pd-l1-test/' target='_blank'>Dana-Farber Cancer Institute: What is PD-L1?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI Cancer Currents Blog: Atezolizumab Approved for Some Patients with Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biooncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Information Page: Ipatasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/taxol-better-than-ixempra-or-abraxane' target='_blank'>Breastcancer.org: Study Confirms Taxol Better Than Ixempra or Abraxane for Locally Advanced or Metastatic Disease</a> </li></ul>

NEAREST SITE: 533 miles
OHSU Knight Cancer Institute
Portland,OR

VISITS: Monthly visits for 1 year

PHASE: II

NCT ID: NCT03801369

Olaparib and Durvalumab in Metastatic Triple Negative Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using the combination of olaparib (Lynparza®) and durvalumab (Imfinzi®).

Who is this for?

People 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">Olaparib (Lynparza®), by mouth, twice daily for 1 month, then once a month for 1 year</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly, for 1 year</li> </ul> Additional procedures: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2-3 tumor biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of ovarian cancer. </li> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy drug called a PD-L1 inhibitor. It gets the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of lung cancer. </li> <li class="seamTextUnorderedListItem">Preclinical studies suggest this drug combination may be effective in patients with 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/NCT03801369' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ex&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>Durvalumab (Imfinzi®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html?source=lyn_d_c_2&umedium=cpc&uadpub=google&ucampaign=lynparzadtcbranded_alone_2019&ucreative=branded_alone_ex&uplace=olapariblynparza&outcome=dtc&cmpid=1' target='_blank'>Olaparib (Lynparza®) Drug Information Page</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03435640

NKTR-262 and NKTR-214 with or without Opdivo for Advanced TNBC (and Other) Cancers

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-262 in Combination With NKTR-214 and in Combination With NKTR-214 Plus Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumor Malignancies (REVEAL) Scientific Title

Purpose

To evaluate the safety and best dose of two experimental immunotherapy drugs when they are given with or without the immunotherapy drug nivolumab (Opdivo®) to treat advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is 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">NKTR-262, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">NKTR-214, by IV, every 3 weeks, ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKTR-262, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">NKTR-214, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks, ongoing</li></ul>
INKTR-262 and NKTR-214 are the experimental immunotherapy drugs being used in this study. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03435640' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/web-exclusives/nktr-214-nivolumab-combination-shows-promise-in-early-study' target='_blank'>OncLive: NKTR-214 and Nivolumab</a> </li></ul>

NEAREST SITE: 602 miles
Novartis Investigative Site
Salt Lake City,UT

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT02947165

NIS793 with Spartalizumab (PDR001) in Patients With Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies Scientific Title

Purpose

To study the safety, effects (good and bad) and best dose of NIS793 when it is used alone or with an immunotherapy.

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIS793, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab (PDR001), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">NIS793, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIS793 is a targeted therapy that binds to the transforming growth factor-beta receptor. </li> <li class="seamTextUnorderedListItem">Spartalizumab is the investigational immunotherapy being used in this study. It is a type of immunotherapy called a PD-L1 checkpoint inhibitor. </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/NCT02947165' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Dictionary: Spartalizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-tgf-beta-monoclonal-antibody-nis793' target='_blank'>NCI Dictionary: NIS793</a> </li></ul>

NEAREST SITE: 637 miles
Research Site
Goodyear,AZ

VISITS: Approximately 1 visit a week

PHASE: I-II

NCT ID: NCT03742102

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA) Scientific Title

Purpose

To look at the safety and effects (good and bad) of the combination of durvalumab (Imfinzi®) and paclitaxel (Taxol®) when used alone or with one of three additional therapies.

Who is this for?

Women with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) being treated for the first time for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Capivasertib (AZD5363), by mouth, twice a day, 3 weeks on and 1 week off</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Danvatirsen (AZD9150), by IV, 3 times in the first week and then weekly</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Oleclumab (MEDI9447), by IV, once every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain types of cancers, and its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxol is a chemotherapy drug routinely used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">The three additional therapies are capivasertib, a targeted therapy that blocks Akt; danvatirsen, a targeted therapy that blocks the STAT3 protein; and oleclumab, which targets CD73.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742102' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>OncLive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/stat3-antisense-oligonucleotide-isis-481464' target='_blank'>NCI Drug Dictionary: Danvatirsen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd73-monoclonal-antibody-medi9447' target='_blank'>NCI Drug Dictionary: Oleclumab</a> </li></ul>

NEAREST SITE: 671 miles
Banner MD Anderson Cancer Center
Gilbert,AZ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04115306

Targeted Therapy PMD-026 for Metastatic Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 671 miles
Banner MD Anderson Cancer Center
Gilbert,AZ

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03901469

ZEN003694 and Talazoparib for Triple Negative Breast Cancer

A Phase 2 Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer Scientific Title

Purpose

To look at the safety and effects (good and bad) of using the experimental drug ZEN003694 along with talazoparib (Talzenna®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have been tested for and found to not have inherited a BRCA1 or BRCA2 mutation Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694, by mouth, once daily </li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, once daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694 is a drug taken by mouth that targets the protein BET. </li> <li class="seamTextUnorderedListItem">This protein helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">It prevents the PARP protein from repairing damaged DNA inside tumor cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat HER2-negative locally advanced or metastatic breast cancer in people with an inherited BRCA mutation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03901469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-approves-talazoparib-for-brcamutated-her2negative-breast-cancer' target='_blank'>OncLive: FDA Approves Talazoparib for BRCA-Mutated, HER2-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/bet-bromodomain-inhibitor-zen-3694' target='_blank'>NCI Drug Dictionary: BET bromodomain inhibitor ZEN-3694</a> </li></ul>

NEAREST SITE: 682 miles
University of Washington Seattle Cancer Center
Seattle,WA

VISITS: At least 1 visit every 2 months

PHASE: I-II

NCT ID: NCT03997968

CYT-0851 for Advanced Solid Tumors and Some Types of Blood Cancers

A Multi-Center, Open Label Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors Scientific Title

Purpose

To study the safety and best dose of CYT-0851, a type of targeted therapy called a RAD51 inhibitor.

Who is this for?

People with triple negative (ER-, PR-, HER2-) metastatic (stage IV) breast cancer that tests positive for a protein called activation-induced cytidine deaminase (AID). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CYT-0851, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RAD51 is a protein that helps cells repair DNA damage. Blocking this process may keep tumors from growing. </li> <li class="seamTextUnorderedListItem">Tumors that test positive for a protein called activation-induced cytidine deaminase (AID) may have high rates of DNA damage. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03997968' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/breast-cancer/rad51-linked-parp-inhibitor-resistance-brca-mutated-breast-cancer' target='_blank'>CancerNetwork.com: RAD51</a> </li></ul>

NEAREST SITE: 941 miles
University of Colorado Cancer Center
Aurora,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02719691

MLN0128 and Alisertib for Metastatic Triple-Negative Breast (and Other Advanced) Cancers

A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Triple-negative Breast Cancer (TNBC) Scientific Title

Purpose

To determine if the combination of Alisertib and MLN0128, an mTOR inhibitor, is safe and effective.

Who is this for?

People with metastatic (stage IV) triple negative breast cancer. You must have received one prior round of chemotherapy, either following surgery for early breast cancer or for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib (MLN8237), by mouth, twice daily, for 1 week every month</li> <li class="seamTextUnorderedListItem">MLN0128, by mouth daily, for 2-3 weeks every month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MLN0128 is a new type of targeted therapy called an mTOR inhibitor.</li> <li class="seamTextUnorderedListItem">Alisertib (MLN8237) is a new targeted therapy that blocks an enzyme--Aurora A kinase--that helps cancer cells grow.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02719691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/study/NCT02719691#contacts' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li></ul>

NEAREST SITE: 941 miles
University of Colorado Aurora
Aurora,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03739931

mRNA-2752 & Durvalumab for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36Î³, for Intratumoral Injection Alone and in Combination With Immune Checkpoint Blockade Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of mRNA-2752 when it is combined with durvalumab (Imfinzi®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has already been treated with adequate standard of care therapies. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"> mRNA-2752, by injection</li> <li class="seamTextUnorderedListItem">IMFINZI® (durvalumab), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">mRNA-2752 is injected directly into a tumor. It is designed to make a tumor more responsive to an immunotherapy drug. </li> <li class="seamTextUnorderedListItem">Imfinzi® is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers. 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/NCT03739931' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ph&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>AstraZeneca Drug Information Page: Imfinzi®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796816' target='_blank'>NCI Drug Dictionary: mRNA-2752</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/79/13_Supplement/CT210' target='_blank'>AACR Abstract: mRNA-2752</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.modernatx.com/pipeline/therapeutic-areas/immuno-oncology' target='_blank'>Drug Company Information Page: Intratumoral Immuno-Oncology Therapeutics</a> </li><li class='seamTextUnorderedListItem'><a href='https://stm.sciencemag.org/content/11/477/eaat9143.full?ijkey=nRihB/hFvaoUw&keytype=ref&siteid=scitransmed' target='_blank'>Journal Article: Durable anticancer immunity from intratumoral administration of IL-23, IL-36γ, and OX40L mRNAs</a> </li></ul>

NEAREST SITE: 948 miles
GSK Investigational Site
Denver,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02783300

Targeted Therapy GSK3326595 for Advanced HER2- Breast (and Other) Cancers

A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma Scientific Title

Purpose

To assess the safety, effects (good and bad) and best dose of an experimental targeted therapy called GSK3326595 that blocks a protein called arginine methyltransferase 5.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is either triple negative (ER-, PR-, HER2-) or hormone positive (ER+ or PR+) and HER2 negative, has progressed on a prior therapy, and, if hormone sensitive, has been treated with a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK3326595, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study will assess the safety, effects (good and bad) and best dose of an experimental targeted therapy called GSK3326595 that blocks a protein called arginine methyltransferase 5. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02783300' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/protein-arginine-methyltransferase-5-inhibitor-gsk3326595' target='_blank'>NCI Drug Dictionary: GSK3326595</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/personalized-and-targeted-therapies/understanding-targeted-therapy?fbclid=IwAR3gFr1adHefp7nRg997kYNvNM6g5sH8qJc3ko5tlY2DoGAtfFa_rRp8H9k' target='_blank'>ASCO: Understanding Targeted Therapy</a> </li></ul>

NEAREST SITE: 948 miles
Sarah Cannon Research Institute at HealthOne
Denver,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04148937

The Targeted Therapy LY3475070 Alone or With Pembrolizumab in Advanced Breast Cancer

A Phase 1 Multicenter Global First in Human Study of the CD73 Inhibitor LY3475070 as Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies Scientific Title

Purpose

To study the safety, anti-cancer activity, and effects (good and bad) of the experimental targeted therapy LY3475070 when it is given alone or with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) breast cancer who have no other standard treatment options. 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">LY3475070, by mouth, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3475070, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3475070 is a type of investigational therapy called a CD73 inhibitor. </li> <li class="seamTextUnorderedListItem">CD73 is a protein that may be a new biomarker in triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat certain other types of cancers. Its use in breast cancer is considered experimental. </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/NCT04148937' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lillytrialguide.com/en-US/studies/advanced-cancer/jzma' target='_blank'>Eli Lilly & Company Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=pembrolizumab&utm_kxconfid=sq7irm3mh&gclid=CjwKCAiA1L_xBRA2EiwAgcLKA1rjY2sDvGijJBKlq4pryVynCh4LO-tR1STTRbK7a6-qFcn3XQre2RoC' target='_blank'>Merck Oncology: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='http://tcr.amegroups.com/article/view/21463/html' target='_blank'>Journal Article: CD73, A New Biomarker in Triple-negative Breast Cancer</a> </li></ul>

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

A Registry for Patients with a Breast Cancer Genetic Mutation or Triple Negative Tumor

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

Purpose

To learn more about the relationship between genetic mutations and cancer outcomes based on the cancer-related information collected.

Who is this for?

Women with triple negative breast cancer and/or inherited genetic mutations. Full eligibility criteria

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This is a data collection (registry) study. Participants will undergo 1 blood test upon enrolling in this study.
People who carry an inherited genetic mutation are at increased risk of developing breast cancer. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BRCA1 and BRCA2 are the most common genetic mutations associated with breast cancer risk. But there are other mutations that also increase breast cancer risk, including PTEN, P53, PALB2, and others. </li> <li class="seamTextUnorderedListItem">Previous studies have found that individuals with triple-negative breast cancer are likely to carry the BRCA mutation.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>Cancer.net: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Mutations</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03775850

Immunotherapy EDP1503 With Pembrolizumab For Advanced Triple Negative Breast Cancer

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

Purpose

To assess the safety and the effects (good and bad) of the immunotherapy EDP1503 when it is given along with pembrolizumab (Keytruda®).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503, by mouth, twice daily, for 2 weeks</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 is an experimental immunotherapy that may work by changing the microenvironment that surrounds the cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">It is only approved to treat certain types of breast cancers. Its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03775850' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795263' target='_blank'>NCI: Monoclonal microbial EDP1503</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pharmacychoice.com/News/article.cfm?Article_ID=2142547' target='_blank'>Pharmacy Choice: Evelo Enters into Clinical Trial Collaboration Agreement with Merck</a> </li><li class='seamTextUnorderedListItem'><a href='https://globenewswire.com/news-release/2019/01/04/1680530/0/en/Evelo-Biosciences-Announces-Dosing-of-First-Patient-in-Phase-1-2-Clinical-Trial-of-EDP1503-in-Combination-with-KEYTRUDA-pembrolizumab-in-Multiple-Oncology-Indications.html' target='_blank'>Evelo Press Release: EDP1503</a> </li></ul>

NEAREST SITE: 1387 miles
University of Oklahoma
Oklahoma City,OK

VISITS: 2 visits per week, ongoing

PHASE: I

NCT ID: NCT03364400

VT1021 in Metastatic Triple Negative Breast Cancer

A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the effects (good and bad) of the experimental drug VT1021.

Who is this for?

People with metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have already received at least three lines of therapy in the metastatic setting. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VT1021, by IV, twice a week, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VT1021 is an experimental targeted therapy that researchers believe may work by affecting the tumor's microenvironment (the tissue surrounding the tumor).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03364400' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://vigeotherapeutics.com' target='_blank'>Drug Company Information Page: VT1021</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2020/03/03/mbc-news-20/' target='_blank'>Metastatic Trial Talk: The Tumor Microenvironment</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

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

VISITS: 1 to 4 visits monthly, ongoing

PHASE: I

NCT ID: NCT03829436

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

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

Purpose

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

Who is this for?

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

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once a month</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, once every 3 weeks</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV, once a week</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120 is an investigational drug that targets a protein called PPARα. </li> <li class="seamTextUnorderedListItem">The other drugs it may be given with are nivolumab (Opdivo®), docetaxel (Taxotere®), and cetuximab (Erbitux®). </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a PD-1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxotere is a chemotherapy drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Erbitux is a targeted therapy that blocks EGFR. It is approved to treat head, neck and colorectal cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03829436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/reading-room/asco/breast-cancer/79947' target='_blank'>Medpage Today: Cetuximab in Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.esmo.org/Oncology-News/Promising-Response-Rates-in-Patients-with-Metastatic-TNBC-Treated-with-Nivolumab-After-Induction-Treatment' target='_blank'>ESMO 2017: Promising Response Rates in Patients with Metastatic TNBC Treated with Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Cancer Research UK: Docetaxel</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/79/13_Supplement/3606' target='_blank'>Cancer Research: TPST-1120 suppresses tumor growth and stimulates anti-tumor immunity</a> </li></ul>

NEAREST SITE: 1479 miles
Mary Crowley Cancer Research Centers
Dallas,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03150810

BGB-290 with Temozolomide for Advanced Breast (and Other) Cancer

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using an oral chemotherapy along with a new targeted drug to treat advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. If you have triple negative disease, you must have received less than three prior therapies for advanced disesse. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-290, by mouth</li> <li class="seamTextUnorderedListItem">Temolozomide, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs being used in this study are temozolomide (Temodar) and BGB-290. </li> <li class="seamTextUnorderedListItem">Temodar is used to treat brain cancer. </li> <li class="seamTextUnorderedListItem">BGB-290 is a type of targeted therapy called a PARP inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03150810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a601250.html' target='_blank'>MedlinePlus: Temozolomide</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.beigene.com/pipeline/clinical-candidates/bgb-290/' target='_blank'>BeiGene: BGB-290</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/temozolomide' target='_blank'>CancerResearchUK: Temozolomide</a> </li></ul>

NEAREST SITE: 1481 miles
South Texas Accelerated Research Therapeutics, LLC
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03875313

Telaglenastat and Talazoparib for Advanced Triple Negative Breast Cancer

A Phase 1b/2 Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor CB-839 in Combination With the PARP Inhibitor Talazoparib in Patients With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of CB-839 (Telaglenastat) when it is used along with talazoparib (Talzenna®).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CB-839 (Telaglenastat), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, twice daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CB-839 (Telaglenastat) is an investigational targeted therapy that blocks an enzyme called glutaminase. </li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It is approved to treat advanced HER2 negative breast cancer in people with an inherited BRCA mutation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03875313' 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: FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/glutaminase-inhibitor-cb-839' target='_blank'>NCI Drug Dictionary: Glutaminase inhibitor CB-839</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology /ID# 210717
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03893955

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-927, by IV</li> <li class="seamTextUnorderedListItem">ABBV-368, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-927 is an immunotherapy that gets the immune system to go after cancer cells by targeting a protein called CD40. </li> <li class="seamTextUnorderedListItem">ABBV-368 is an immunotherapy that targets OX40, which is found on certain T cells. </li> <li class="seamTextUnorderedListItem">This study is also recruiting patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03893955' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-abbv-927' target='_blank'>NCI Drug Dictionary: ABBV-927</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-368.html' target='_blank'>Drug company information page: ABBV-368</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology /ID# 208930
San Antonio,TX

VISITS: 1 visit every month, ongoing

PHASE: I

NCT ID: NCT03821935

ABBV-151 and ABBV-181 for Advanced Triple Negative Breast Cancer

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To investigate the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181.

Who is this for?

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

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You will be assigned to 1 of the 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">ABBV-181, by IV, once a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. </li> <li class="seamTextUnorderedListItem">ABBV-181 is an experimental PD-1 inhibitor. This type of immunotherapy, called a checkpoint inhibitor, gets the immune system to 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/NCT03821935' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-151.html' target='_blank'>Drug company information page: ABBV-151</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/abbv-181/' target='_blank'>Immuno-oncology news: ABBV-181</a> </li></ul>

NEAREST SITE: 1481 miles
South Texas Accelerated Research Therapeutics (START)
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04344795

TPST-1495 Alone or With Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase 1a/1b Open Label Dose-escalation and Expansion Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of TPST-1495 alone and in combination with pembrolizumab (Keytruda®).

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1495, by mouth, twice a day, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1495, by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1495 is an experimental (only available in clinical trials) targeted therapy.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat only certain types of breast cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04344795' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwv4_1BRAhEiwAtMDLsqE2Q3a74MSBt-Qt-jPAPtFkWZ4hjxPY6s9hW1c5ZyCjJkFSvzZULhoCbjYQA' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tempesttx.com/file.cfm/33/docs/2019-sitc-poster-p311.pdf' target='_blank'>Drug Company Information Page: TPST-1495</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 1481 miles
Novartis Investigative Site
San Antonio,TX

VISITS: 5 visits over the first 3 weeks, then one visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT02829723

BLZ945 Alone or With PDR001 For Metastatic Breast (and Other) Cancer

A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors Scientific Title

Purpose

To investigate whether a new type of targeted cancer drug is safe and effective when it is given alone or with an immunotherapy drug.

Who is this for?

This study has two phases: Phase 1 is for people with any type of metastatic (stage iV) breast cancer; Phase II is for people with metastatic, triple negative breast cancer. Full eligibility criteria

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You will receive one of the following treatments: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLZ945</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLZ945 and PDR001</li> </ul> Please contact research site for treatment schedule.
The targeted drug being used in this study is called BLZ945. It targets a receptor called CSF1R that plays a role in tumor growth. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This is the first study to test this new targeted drug in cancer patients. </li> <li class="seamTextUnorderedListItem">Some patients who enroll in this study will also receive an immunotherapy drug called PDR001.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02829723' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=770801' target='_blank'>NCI Drug Dictionary: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3902121/' target='_blank'>OncoImmunology: CSF1R</a> </li></ul>

NEAREST SITE: 1482 miles
Baylor Scott and White University Medical Center
Dallas,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04032080

LY3023414 Followed by Prexasertib in Metastatic Triple Negative Breast Cancer

Pilot Clinical Trial Of Treatment With Oral LY3023414 To Inhibit Homologous Recombination (HR) Followed By Prexasertib In Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer (ExIST) Scientific Title

Purpose

To look at the safety and effects (good and bad) of treating patients with the investigational targeted therapy LY3023414 followed by the investigational targeted therapy prexasertib.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer who have not had more than 3 chemotherapy regimens. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3023414, by mouth, twice a day, until disease progression </li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Prexasertib, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3023414 is a type of targeted therapy called a PI3K/mTOR inhibitor. </li> <li class="seamTextUnorderedListItem">Prexasertib is a targeted therapy that blocks checkpoint kinase1 (chk1), which plays a role in chemotherapy drug resistance.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04032080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/prexasertib' target='_blank'>NCI Drug Dictionary: Prexasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-mtor-inhibitor-ly3023414' target='_blank'>NCI Drug Dictionary: LY3023414</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.1064' target='_blank'>Journal of Clinical Oncology: Safety and tolerability of LY3023414 in combination with fulvestrant in treatment refractory advanced breast cancer</a> </li></ul>

NEAREST SITE: 1482 miles
Baylor University Medical Center
Dallas,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03193853

Targeted therapy followed by Chemotherapy for Metastatic Triple Negative Breast Cancer

Phase II Clinical Trial of Treatment With TAK-228 and TAK-117 to Inhibit Homologous Recombination (HR) Followed by Cisplatin and Nab Paclitaxel in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using two targeted drugs (TAK-228 and TAK-117) followed by chemotherapy.

Who is this for?

Women with triple negative metastatic (stage IV) breast cancer. Your tumor must test negative for androgen receptors. In addition, you must have already had chemotherapy (anthracycline, cyclophosphamide, and taxane). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAK-228 and TAK-117, by mouth, until disease progression</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Paraplatin®) and nab-paclitaxel (Abraxane®), by IV, as long as benefit is shown</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted drugs used in this study are TAK-228 and TAK-117. Both are mTOR inhibitors. </li> <li class="seamTextUnorderedListItem">mTOR is a kinase, a type of protein found in the body. Kinases help all cells -- both healthy and cancerous – get the energy they need. When kinases don’t act normally or are overactive, they help certain breast cancers grow. mTOR inhibitors interfere with the mTOR kinase, which stops cancer cells from getting the energy they need to grow. (Breastcancer.org)</li> <li class="seamTextUnorderedListItem">Cisplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) are the chemotherapy 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/NCT03193853' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1482 miles
Texas Oncology, PA
Dallas,TX

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?

People 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: 1482 miles
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03952325

Tesetaxel and Immunotherapy in Advanced HER2- Breast Cancer

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC (CONTESSA TRIO) Scientific Title

Purpose

To compare the safety and effects (good and bad) of an experimental oral chemotherapy drug called tesetaxel when it is given with one of three immunotherapy drugs as well as the safety and effects of tesetaxel when it is given alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) who have not received prior chemotherapy for advanced disease; or people, 65 or older, who have advanced or metastatic HER2 negative breast cancer and have not received prior chemotherapy for advanced disease. Full eligibility criteria

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Cohort 1: You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nivolumab, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li> <li class="seamTextUnorderedListItem">Atezolizumab, by IV, every 3 weeks</li> </ul> Cohort 2: For over 65 years old with HER2 negative breast cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tesetaxel, by mouth, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To take part in the first cohort, you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have not received prior chemotherapy for advanced disease. </li> <li class="seamTextUnorderedListItem">To be part of the second cohort, you must be age 65 or older, have advanced or metastatic HER2 negative breast cancer, and have not received prior chemotherapy for advanced disease. </li> <li class="seamTextUnorderedListItem">In the first cohort, this study is comparing the safety and effects (good and bad) of an experimental oral chemotherapy drug called tesetaxel when it is given with one of three immunotherapy drugs. </li> <li class="seamTextUnorderedListItem">In the second cohort, the study is investigating the safety and effects (good and bad) of tesetaxel when it is given alone. </li> <li class="seamTextUnorderedListItem">The three immunotherapy drugs being used in this study are nivolumab (Opdivo®), pembrolizumab (Keytruda®), and atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Opdivo and Keytruda are PD-1 inhibitors. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). Both are approved for certain types of cancers. Their use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a PD-L1 inhibitor. It gets the immune system to go after cancer cells by blocking PD-L1. </li> <li class="seamTextUnorderedListItem">Tecentriq in combination with Abraxane is an FDA-approved treatment for 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/NCT03952325' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/issues/july-25-2018/oral-taxane-shows-strong-activity-and-good-tolerability-in-metastatic-breast-cancer/' target='_blank'>ASCO post: Oral Taxane Shows Strong Activity and Good Tolerability in MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/peer-exchange/unmet-needs-mbc/tesetaxel-an-oral-taxane-for-hr-positive-mbc' target='_blank'>OncLive: Tesetaxel: An Oral Taxane for HR-Positive mBC</a> </li></ul>

NEAREST SITE: 1482 miles
Texas Oncology-Baylor -Charles A. Sammons Cancer Center
Dallas,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03094169

AVID100 in Advanced Epithelial Carcinomas

Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin Scientific Title

Purpose

To determine the safety and effects (good and bad) of using an experimental targeted therapy called AVID100.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVID100 IV, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVID100 is a targeted antibody-drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">It targets EGFR proteins to deliver a chemotherapy drug called maytansinoid mertansine (DM1).</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of tumors that test EGFR positive.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03094169' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/792639' target='_blank'>NCI Drug Dictionary: AVID100</a> </li></ul>

NEAREST SITE: 1506 miles
HCA Midwest Division
Kansas City,MO

VISITS: 2 visits every 3 weeks

PHASE: III

NCT ID: NCT03371017

Atezolizumab plus Chemotherapy for Early Relapsing Recurrent Triple Negative Breast Cancer

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer Scientific Title

Purpose

To determine the safety and effects (good and bad) of giving chemotherapy with an immunotherapy agent to giving chemotherapy alone for advanced breast cancer.

Who is this for?

People with triple negative (ER-/PR-/HER2-) advanced (some stage III) or metastatic (stage IV) breast cancer. You must not have received any prior anti-cancer therapy for stage III or stage IV breast cancer. Your cancer must have progressed within 1 year from receiving treatment for early stage breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) by IV, once every 3 weeks </li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) by IV, twice every 3 weeks </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, twice every 3 weeks </li> <li class="seamTextUnorderedListItem">Capacitabine (Xeloda®), by mouth, daily, for 2 weeks, followed by a 7-day rest period </li> </ul> Group 2: Placebo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo by IV, once every 3 weeks </li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) by IV, twice every 3 weeks </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, twice every 3 weeks </li> <li class="seamTextUnorderedListItem">Capacitabine (Xeloda®), by mouth, daily, for 2 weeks, followed by a 7-day rest period</li></ul>
The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The chemotherapy drugs used in this study are gemcitabine (Gemzar®), carboplatin (Paraplatin®) and capecitabine (Xeloda®). </li> <li class="seamTextUnorderedListItem">Gemzar is a chemotherapy drug used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Paraplatin is a platinum-based chemotherapy drug that is commonly used to treat triple negative breast cancer. </li> <li class="seamTextUnorderedListItem">Xeloda is commonly used to treat metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03371017' 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: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: 1 visit per month, ongoing

PHASE: II

NCT ID: NCT03941730

Estradiol in Advanced Triple Negative Tumors that Test Positive for ER Beta

Therapeutic Targeting of ER Beta in Triple Negative Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) of estradiol in the subset of triple negative tumors that test positive for ER beta.

Who is this for?

Women with with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer who have a tumor that tests positive for estrogen receptor beta (ER beta). Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 3 times a day</li> <li class="seamTextUnorderedListItem">2 biopsies (at the start of treatment and after 1 month)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early studies suggest that estradiol--a type of estrogen--slows the growth of tumors that are ER-beta positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03941730' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/estradiol.html' target='_blank'>Drugs.com: Estradiol</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/30338035' target='_blank'>Pubmed: Estrogen receptor-beta is a potential target for TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/centers-programs/cancer-research/research-programs/womens-cancer-program/breast-cancer-spore/research-projects/therapeutic-targeting-estrogen-receptor-beta-triple-negative-breast-cancer' target='_blank'>Mayo Clinic: Therapeutic Targeting Estrogen receptor-beta in TNBC</a> </li></ul>

NEAREST SITE: 1643 miles
Houston Methodist Hospital
Houston,TX

VISITS: Visits daily, ongoing

PHASE: I-II

NCT ID: NCT02834403

L-NMMA plus Taxotere for Advanced Triple Negative Breast Cancer

Clinical Phase Ib Trial of L-NMMA Plus Docetaxel in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients Scientific Title

Purpose

To determine the best dose, safety and effects of L-NMMA when it is given with a chemotherapy drug that is used to treat advanced breast cancer.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. If you are stage III, you must have received at least 3 types of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">L-NMMA, by IV, daily for 5 days, every 3 weeks</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, once every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Scientists have created new drugs to treat triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">One of these new drugs is called L-NMMA. </li> <li class="seamTextUnorderedListItem">L-NMMA targets the NOS (nitric oxide synthase) inhibitor.</li> <li class="seamTextUnorderedListItem">The chemotherapy drug being used is docetaxel (Taxotere®).</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02834403' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02834403?term=NCT02834403&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li></ul>

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02926690

OTS167PO: A Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer Scientific Title

Purpose

To determine the safety and effects (good and bad) of using an experimental drug called OTS167PO to treat advanced and metastatic breast cancer.

Who is this for?

People 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 receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OTS167PO </li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The drug used in this trial is OTS167PO. It is a type of new treatment called a MELK inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02926690' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03654547

TT-00420 For Advanced Triple Negative Breast Cancer

A Phase I, First-In-Human, Multicenter, Open-Label Study of TT-00420, Administered Orally in Adult Patients With Advanced Solid Tumors and Triple Negative Breast Cancers Scientific Title

Purpose

To study the best dose, safety, and effects (good and bad) of an investigational targeted therapy called TT-00420.

Who is this for?

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

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TT-00420, by mouth, once daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TT-00420 blocks the growth of the new blood vessels tumors need to grow and targets tumor inflammation.</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/NCT03654547' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://abstracts.asco.org/239/AbstView_239_266885.html' target='_blank'>ASCO abstract: TT-00420</a> </li></ul>

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

VISITS: 4 visits every 6 weeks, ongoing

PHASE: I

NCT ID: NCT03579472

M7824 and Halaven for Metastatic Triple Negative Breast Cancer

A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To find the best dose of M7824 to use with eribulin (Halaven).

Who is this for?

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

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M7824, by IV, weekly, for 3 out of every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Eribulin, by IV, weekly, for 4 out of every 6 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M7824 is an investigational immunotherapy drug. </li> <li class="seamTextUnorderedListItem">It gets immune cells to see cancer cells by blocking PD-L1 and TGF-beta. </li> <li class="seamTextUnorderedListItem">Halaven is used to treat patients who have already had at least two other anticancer medicines for their metastatic breast cancer and who have already been treated with an anthracycline and a taxane for either early or 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/NCT03579472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/io-m7824/' target='_blank'>Immuno-Oncology News: M7824</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.halaven.com/metastatic-breast-cancer' target='_blank'>Drug Company Information Page: Halaven</a> </li></ul>

NEAREST SITE: 1643 miles
Kymab investigator site 1101
Houston,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03829501

KY1044 and Atezolizumab Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies Scientific Title

Purpose

To study the safety and the effects (good and bad) of using KY1044 alone or with Tecentriq® (atezolizumab) to treat advanced breast cancer.

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1: Monotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044</li> </ul> Group 2: Combination Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044 stimulates immune cells to go after and kill cancer cells. </li> <li class="seamTextUnorderedListItem">It also kills the T regulatory cells that keep immune cells from killing the cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq® (atezolizumab) is a type of immunotherapy called a PD-L1 (programmed cell death-ligand 1) inhibitor. </li> <li class="seamTextUnorderedListItem">It is approved to treat advanced triple negative breast cancer, as well as 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/NCT03829501' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.statnews.com/2019/03/08/roche-tecentriq-first-breast-cancer-immunotherapy/' target='_blank'>StatNews: Tecentriq approval for breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.kymab.com/news-and-events/news/2017/nov/8/ky1044-anti-icos-antibody-sitc/' target='_blank'>Drug Sponsor Site: KY1044</a> </li></ul>

NEAREST SITE: 1643 miles
Houston Methodist Cancer Center
Houston,TX

VISITS: 1 visit daily for 2 weeks, then every 3 weeks ongoing

PHASE: II

NCT ID: NCT03004183

Radiation & A New Immunotherapy Before Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Oncolytic Virus Therapy in Metastatic Triple Negative Breast Cancer and Metastatic Non-Small Cell Lung Cancer Followed by Pembrolizumab (STOMP) Scientific Title

Purpose

To investigate the safety and effects (good and bad) of delivering radiation (SBRT) and vaccine therapy prior to the immunotherapy Keytruda®.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADV/HSV-tk, by injection, once</li> <li class="seamTextUnorderedListItem">followed by valacyclovir (anti-viral drug), by mouth, daily, for 2 weeks</li> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), 5 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">followed by pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The vaccine is called ADV/HSV-tk. It is given along with the anti-viral drug valacyclovir. </li> <li class="seamTextUnorderedListItem">The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">This study is also recruiting patients with advanced 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/NCT03004183' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.nature.com/nrd/journal/v14/n9/full/nrd4663.html?foxtrotcallback=true' target='_blank'>Nature Reviews Drug Discovery: Oncolytic viruses: a new class of immunotherapy drugs</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/20659' target='_blank'>ASCO: Pembrolizumab for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.webmd.com/drugs/2/drug-6279/valacyclovir-oral/details' target='_blank'>WebMD: Valacyclovir</a> </li></ul>

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: 2 visits every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03992131

Rubraca & Sacituzumab Govitecan to Treat Metastatic Triple Negative or BRCA+ Tumors

SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor Scientific Title

Purpose

To study the safety and effects (good and bad) of the combination of rucaparib (Rubraca®) and sacituzumab govitecan.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has been treated with at least one standard therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (IMMU-132), by IV, 2 times every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rubraca is a PARP inhibitor approved to treat recurrent ovarian, fallopian tube, and primary peritoneal cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan is a type of cancer therapy called an antibody-drug conjugate. It uses an antibody that targets cancer cells to deliver the drug SN-38 directly to these cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03992131' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/rucaparib-phosphate' target='_blank'>NCI Drug Dictionary: Rucaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clovisoncology.com/pipeline/rucaparib/' target='_blank'>Drug company information site: Rucaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sacituzumab-govitecan' target='_blank'>NCI Drug Dictionary: Sacituzumab govitecan</a> </li></ul>

NEAREST SITE: 1643 miles
Novartis Investigative Site
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03549000

NZV930, PDR001 and NIR178 Immunotherapies in Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies. Scientific Title

Purpose

To compare the safety and effects (good and bad) of NZV930 alone or in combination with PDR001 and/or NIR178.

Who is this for?

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

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You will be assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV </li> <li class="seamTextUnorderedListItem">PDR001, by IV</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV</li> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV</li> <li class="seamTextUnorderedListItem">PDR001, by IV</li> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> </ul> Please contact research site for treatment schedule Additional procedures: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies (a new tumor biopsy at screening and during treatment)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930 is an investigational targeted therapy that blocks the CD73 protein. Blocking this protein allows T cells and other immune cells to attack the tumor. </li> <li class="seamTextUnorderedListItem">PDR001 is an investigational immunotherapy. It is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">NIR178 is an investigational immunotherapy. It is an immune checkpoint inhibitor that gets the immune system to attack cancer cells by blocking the adenosine A2A receptor (A2AR).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03549000' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.surfaceoncology.com/our-science/srf373-nzv930-cd73-antibody/' target='_blank'>Sponsor site: AZV930</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793151' target='_blank'>NCI Drug Dictionary: NIR178</a> </li></ul>

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04234113

SO-C101 (Immunotherapy) Alone or With Pembrolizumab In Advanced Triple Negative Breast Cancer

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, anti-tumor activity and effects (good and bad) of the experimental immunotherapy drug SO-C101 (RLI-15) when it is given alone or in combination with pembrolizumab (Keytruda®).

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SO-C101</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SO-C101</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SO-C101 (RLI-15) is a new type of immunotherapy that works by getting immune cells called natural killer cells to kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (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> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04234113' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sotio.com/pipeline/so-c101' target='_blank'>Drug Company Information Page: SO-C101 (RLI-15)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAiA1rPyBRAREiwA1UIy8AIFO2xkZ72nv59oRzgEL2_j5xbdlfT_f9w1NuFPTrkeUqYvN9yqxxoCBOYQA' target='_blank'>Merk Oncology Drug Information: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerhealth.com/article/immunotherapies-show-mixed-results-triplenegative-breast-cancer' target='_blank'>Cancer Health: Immunotherapies Show Mixed Results for Triple-Negative Breast Cancer</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03207529

Alpelisib & Enzalutamide in Advanced Breast Cancer That Tests AR+ and PTEN+

Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer Scientific Title

Purpose

To determine the best dose, safety, and effects (good and bad) of alpelisib (Piqray®) when it is used along with enzalutamide (Xtandi®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER positive and/or PR positive) or triple negative (ER-, PR-, HER2-) breast cancer that tests AR-positive and PTEN-positive and has been treated with at least one standard therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Piqray is a targeted therapy that inhibits PI3K. It is approved to treat advanced hormone receptor positive, HER2 negative breast cancer in patients with a tumor that has a PIK3CA mutation. </li> <li class="seamTextUnorderedListItem">Xtandi is an oral drug that targets the androgen receptor (AR). It is approved to treat advanced prostate cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AR, PTEN</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03207529' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/news/media-releases/novartis-investigational-byl719-alpelisib-plus-fulvestrant-consistently-improved-pfs-patients-pik3ca-mutated-hrher2-advanced-breast-cancer-new-solar-1-analyses' target='_blank'>Novartis Press Release: BYL719 (alpelisib) plus fulvestrant for PIK3CA mutated HR+/HER2- advanced breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/enzalutamide' target='_blank'>NCI Drug Dictionary: Enzalutamide</a> </li></ul>

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

VISITS: Visits every 3 weeks

PHASE: II

NCT ID: NCT02411656

Keytruda for Metastatic Inflammatory Breast Cancer

A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer Who Have Received Prior Chemotherapy With Clinical Response Scientific Title

Purpose

To look at the safety and effects (good and bad) of using Keytruda.

Who is this for?

People with metastatic (stage IV) triple negative or inflammatory breast cancer. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-3475, by IV, every 3 weeks, up to 2 years</li></ul>
Pembrolizumab (Keytruda®) is an immunotherapy that helps the body's immune system slow or stop cancer cell growth by blocking a protein known as programmed cell death receptor-1 (PD-1). <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda® is approved for treating certain types of cancers. </li> <li class="seamTextUnorderedListItem">Early studies suggest Keytruda® may also be effective for treating metastatic inflammatory breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02411656' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.mdanderson.org/publications/oncolog/previous-issues/2015-july/immunotherapy-trials-offer-hope-to-patients-with-high-risk-or-metastatic-breast-cancer.html' target='_blank'>MD Anderson: Immunotherapy Trials for High-Risk or Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www2.mdanderson.org/depts/oncolog/articles/12/9-sep/9-12-2.html' target='_blank'>MD Anderson: Inflammatory Breast Cancer</a> </li></ul>

NEAREST SITE: 1655 miles
University of Iowa Hospital and Clinics
Iowa City,IA

VISITS: Weekly visits, ongoing

PHASE: I-II

NCT ID: NCT03911973

Gedatolisib and Talazoparib in Advanced Triple Negative or Inherited BRCA 1/2 Positive, HER2 Negative Breast Cancer

Phase 2 Trial With Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Big Ten Cancer Research Consortium BTCRC-BRE18-337 Scientific Title

Purpose

To determine the safety, best dose, and effects (good and bad) of gedatolisib when it is used in combination with talazoparib (Talzenna®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose cancer is triple negative (ER-, PR-, HER2-) or HER2 negative (HER2-) and they have an inherited BRCA1 or BRCA2 mutation. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by IV, once a week </li> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, once a day</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy that works by blocking two proteins, called PI3K and mTOR, that help tumors grow. </li> <li class="seamTextUnorderedListItem">Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat HER2 negative advanced or metastatic breast cancer in people with an inherited BRCA mutation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03911973' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-approves-talazoparib-for-brcamutated-her2negative-breast-cancer' target='_blank'>OncLive: FDA Approves Talazoparib for BRCA-Mutated, HER2- Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/files/news/asco/Pfizer_IO_GetaPI3KFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 1754 miles
Cancer Care Specialists of Central Illinois-Swansea
Swansea,IL

VISITS: 1 visit every 3 weeks, for up to 2 years

PHASE: II

NCT ID: NCT04024800

AE37 Vaccine and Keytruda in Metastatic Triple Negative Breast Cancer

A Phase II Clinical Trial of Pembrolizumab in Combination With the AE37 Peptide Vaccine in Patients With Metastatic Triple-Negative Breast Cancer (NSABP FB-14) Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of an AE37 peptide vaccine (AE37) when it is given along with pembrolizumab (Keytruda®).

Who is this for?

People with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) who have 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">AE37 Peptide vaccine, by injection, once every 3 weeks, for 4 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda® ), by IV, once every 3 weeks, for up to 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The vaccine is a type of immunotherapy. It gets the immune cells to see and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to see and kill cancer cells by blocking a checkpoint called PD-1. It is approved to treat metastatic breast tumors that genomic testing has shown are microsatellite instability-high (MSI-H) or have a DNA mismatch repair deficiency (dMMR).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04024800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/news/pembrolizumab-and-chemotherapy-met-primary-endpoint-in-phase-iii-tnbc-trial' target='_blank'>Targeted Oncology: Pembrolizumab and Chemotherapy Met Primary Endpoint in Phase III TNBC Trial</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ae37-peptide-gm-csf-vaccine' target='_blank'>NCI Drug Dictionary: AE37 peptide</a> </li></ul>

NEAREST SITE: 1857 miles
University of Chicago
Chicago,IL

VISITS: Weekly visits, ongoing

PHASE: II

NCT ID: NCT02788981

Abraxane & Mifepristone in Advanced Triple Neg Breast Cancer with Glucocorticoid Receptors

A Randomized, Placebo-Controlled, Double-Blind, Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel, Abraxane®) With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer Scientific Title

Purpose

To determine the safety and effects (good and bad) of using chemotherapy along with a steroid.

Who is this for?

People with triple negative (ER-, PR-, HER2-) 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">Mifepristone, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on, 1 week off)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The chemotherapy drug being used in this study is nab-paclitaxel (Abraxane®). It is approved to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">The steroid being used in this study is mifepristone. </li> <li class="seamTextUnorderedListItem">Researchers believe blocking the glucocorticoid receptor may make chemotherapy more effective.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02788981' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3860283/' target='_blank'>Glucocorticoid receptor antagonism for TNBC</a> </li></ul>

NEAREST SITE: 1946 miles
Indiana University Health Melvin Bren Simon Cancer Center
Indianapolis,IN

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03206203

Carboplatin plus Atezolizumab for Metastatic Triple Negative Breast Cancer

A Phase II Trial of Atezolizumab (Anti-PDL1) With Carboplatin in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To investigate whether using a combination of immunotherapy and chemotherapy is better than using chemotherapy alone to treat triple negative metastatic breast cancer.

Who is this for?

People with metastatic (stage IV) triple negative breast cancer. You may have had up to one prior regimen of chemotherapy for metastatic disease that did not include carboplatin. 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">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing</li></ul>
Carboplatin (Paraplatin®) is the chemotherapy drug used in this study. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is the immunotherapy drug used in this study. It is an anti-PDL1 medicine.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03206203' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1946 miles
IU Simon Cancer Center
Indianapolis,IN

VISITS: Weekly visits, ongoing

PHASE: I

NCT ID: NCT03243331

Gedatolisib plus PTK7-ADC for Metastatic Triple Negative Breast Cancer

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using two investigational drugs to treat metastatic triple negative breast cancer.

Who is this for?

People with metastatic (stage IV) breast cancer that is triple negative. You must have received at least 1 prior chemotherapy regimen for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly (3 weeks on, 1 week off), ongoing </li> <li class="seamTextUnorderedListItem">PTK7-ADC (PF-06647020), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs are gedatolisib and PTK7-ADC. </li> <li class="seamTextUnorderedListItem">Gedatolisib is a targeted therapy that works by blocking PI3K and mTOR kinase proteins, which play a role in the cellular pathways that help tumors grow. </li> <li class="seamTextUnorderedListItem">PTK7-ADC (PF-06647020) targets a protein called PTK7, which is often found on cancer cells. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a drug that can kill these cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03243331' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/files/news/asco/Pfizer_IO_GetaPI3KFactSheet.pdf' target='_blank'>Pfizer: Gedatolisib</a> </li></ul>

NEAREST SITE: 1946 miles
Indiana University
Indianapolis,IN

VISITS: Visits weekly, ongoing

PHASE: II

NCT ID: NCT02755272

Keytruda with Chemotherapy for Metastatic Triple Negative Breast Cancer

A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To learn how well Keytruda immunotherapy works with chemotherapy to treat metastatic triple negative breast cancer.

Who is this for?

Women with metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-) 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</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and gemcitabine (Gemzar®) by IV, once a week, 2 weeks on 1 week off</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and gemcitabine (Gemzar®) by IV, once a week, 2 weeks on 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an immunotherapy drug that gets the immune system to seek out cancer cells. It is used to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">In this study, Keytruda will be combined with two chemotherapy drugs currently used to treat advanced breast cancer that has not responded to other chemotherapy drugs: carboplatin (Paraplatin®) and gemcitabine (Gemzar®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02755272' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02755272?term=NCT02755272&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li></ul>

NEAREST SITE: 1946 miles
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis,IN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04134884

ASTX727 and Talazoparib in Advanced HER2 Negative Breast Cancer

A Phase I Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using the PARP inhibitor Talazoparib (Talzenna®) along with the targeted therapy ASTX727.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have already received chemotherapy or a CDK 4/6 inhibitor with hormone therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">ASTX727, by mouth, first 5 days of every cycle (28 days), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of drug called a PARP inhibitor. It works by preventing the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is approved to treat advanced or metastatic HER2 negative (HER2-) breast cancer in people with an inherited BRCA 1 or BRCA 2 mutation.</li> <li class="seamTextUnorderedListItem">ASTX727 is an investigational targeted therapy that is only available in clinical trials.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04134884' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_+pfizer++talazoparib&skwid=43700051780428716' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/expertconnections/parp-inhibition-brca-mutated-breast-cancer/benefit-of-parp-inhibitors-in-brca-positive-breast-cancer' target='_blank'>Cure Today: Benefit of PARP Inhibitors in BRCA+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cda-inhibitor-e7727-decitabine-combination-agent-astx727' target='_blank'>NCI Drug Dictionary: ASTX727 (CDA Inhibitor E7727)</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/astx727-oral-dnmt-inhibitor-hematological-malignancies/' target='_blank'>Drug Company Information Page: ASTX727 (Cedazuridine and Decitabine)</a> </li></ul>

NEAREST SITE: 1959 miles
Novartis Investigative Site
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03891953

Immunotherapy DKY709 Alone or With PDR001 in Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center, Study of DKY709 as a Single Agent and in Combination With PDR001 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To compare the safety and effects (good and bad) of DKY709 alone and in combination with PDR001.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not been treated with a PD-1 or PD-L1 checkpoint inhibitor. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709</li> <li class="seamTextUnorderedListItem">PDR001 (Spartalizumab)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709 is an investigational immunotherapy. </li> <li class="seamTextUnorderedListItem">PDR001 (spartalizumab) is an investigational immunotherapy that targets PD-1 .</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03891953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: Spartalizumab</a> </li></ul>

NEAREST SITE: 1959 miles
Novartis Investigative Site
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03742349

Four Immunotherapy Combinations in Advanced Triple Negative Breast Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of spartalizumab and LAG525 when they are used in combination with NIR178, capmatinib, MCS110, or canakinumab.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not received more than two prior lines of chemotherapy, including neoadjuvant or adjuvant chemotherapy; and have had a taxane-based chemotherapy as neoadjuvant or metastatic treatment. Full eligibility criteria

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What's involved?
What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab (PDR001), by IV</li> <li class="seamTextUnorderedListItem">LAG525, by IV</li> </ul> with 1 of the following 4 drugs: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> <li class="seamTextUnorderedListItem">Capmatinib (INC280), by mouth</li> <li class="seamTextUnorderedListItem">MCS110 (INC280), by IV</li> <li class="seamTextUnorderedListItem">Canakinumab (ACZ885), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab is an investigational PD-1 immune checkpoint inhibitor. </li> <li class="seamTextUnorderedListItem">LAG525 is an investigational immune checkpoint inhibitor that targets LAG-3. </li> <li class="seamTextUnorderedListItem">NIR178 is an investigational immunotherapy. </li> <li class="seamTextUnorderedListItem">Capmatinib is a targeted therapy that blocks c-Met, which plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">MCS110 is an investigational immunotherapy that targets M-CSF. </li> <li class="seamTextUnorderedListItem">Canakinumab is an investigational monoclonal antibody that targets human interleukin-1 beta (IL-1b), which plays a role in inflammation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742349' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: Spartalizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-lag-3-monoclonal-antibody-lag525' target='_blank'>NCI Drug Dictionary: LAG525</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/capmatinib' target='_blank'>NCI Drug Dictionary: Capmatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-m-csf-monoclonal-antibody-mcs110' target='_blank'>NCI Drug Dictionary: MCS110</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795723' target='_blank'>NCI Drug Dictionary: Canakinumab</a> </li></ul>

NEAREST SITE: 1959 miles
Tennessee Oncology, PLLC
Nashville,TN

VISITS: 1 visit a week, ongoing

PHASE: I-II

NCT ID: NCT04180371

BT5528 Alone or With Nivolumab in Advanced Triple Negative Breast Cancer That Tests EphA2+

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of an experimental therapy called BT5528 when it is given alone or with nivolumab (Opdivo®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-), have already tried other cancer treatments, have no other standard treatment options, and have a tumor that tests positive for a protein called EphA2. Full eligibility criteria

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What's being studied?
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This trial is being conducted in two parts. You will participate in 1 of 2 parts depending on when you enroll: Part 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> </ul> Part 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once every 4 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528 targets a protein called EphA2 that helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">EphA2 is found on some triple negative breast tumors. </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 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/NCT04180371' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Information Page: BT5528</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/onc2017170' target='_blank'>Journal Article: Targeting EphA2 In Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com/about-opdivo/how-opdivo-works-monotherapy' target='_blank'>Bristol-Meyers Squibb Information Page: Opdivo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/publications/cure/2019/immunotherapy-2019/breast-cancer-gets-a-boost-from-immunotherapy' target='_blank'>Cure Today: Breast Cancer Gets a Boost From Immunotherapy</a> </li></ul>

100

NEAREST SITE: 2010 miles
University of Alabama at Birmingham
Birmingham,AL

VISITS: After first 2 weeks of treatment, weekly visits, ongoing

PHASE: I

NCT ID: NCT01920061

SGN-LIV1A in HER2-Negative Metastatic Breast Cancer

A Phase 1B Open-Label Three-Arm Multi-Center Study To Assess The Safety And Tolerability Of PF-05212384 (PI3K/MTor Inhibitor) In Combination With Other Anti-Tumor Agents Scientific Title

Purpose

To assess the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A .

Who is this for?

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

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Participants will be assigned to 1 of 3 groups: Group 1: Advanced Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-05212384 by IV once a week</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) by IV every 3 weeks </li> </ul> Group 2: Triple-Negative Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-05212384 by IV once a week</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) by IV every 3 weeks</li> </ul> Group 3: HER2-positive Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-05212384 by IV once a week</li> <li class="seamTextUnorderedListItem">Dacomitinib (PF-00299804) by mouth daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibody-drug conjugates (ADCs) are cancer therapies that combine an antibody that targets cancer cells with a drug that can kill cancer cells. 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> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01920061' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.pfizer.com/files/news/asco/dacomitinib_fact_sheet.pdf' target='_blank'>Pfizer: Dacomitinib</a> </li><li class='seamTextUnorderedListItem'><a href='http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C91732' target='_blank'>NCI Thesaurus: PI3 Kinase/mTOR inhibitor</a> </li></ul>

101

NEAREST SITE: 2108 miles
Ohio State University
Columbus,OH

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03414684

Carboplatin plus Nivolumab in Advanced Triple Negative Breast Cancer

A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First- or Second-line Metastatic Triple-negative Breast Cancer Scientific Title

Purpose

To compare the safety and effect (good and bad) of giving the chemotherapy drug carboplatin (Paraplatin®) alone or with an immunotherapy drug to treat advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You may have received up to one prior regimen of chemotherapy for metastatic 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">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks, ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing</li></ul>
Paraplatin is a chemotherapy drug routinely used to treat advanced breast cancer. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is the PD-1 inhibitor nivolumab (Opdivo®). The drug, which has been approved to treat certain types of cancer, but not breast cancer, stimulates the body's immune system to attack cancer cells by blocking a protein called PD-1 (programmed cell death-1).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03414684' 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='https://www.mdanderson.org/publications/cancerwise/2015/04/finding-hope-after-triple-negative-breast-cancer.html' target='_blank'>MDAnderson: Finding Hope After Triple Negative Breast Cancer</a> </li></ul>

102

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

VISITS: 4 visits over the first 2 weeks, then 1 visit every 3 weeks for 2 years

PHASE: NA

NCT ID: NCT03599453

Chemokine Modulation and Keytruda in Advanced Triple Negative Breast Cancer

Pilot Open Label Clinical Trial Evaluating the Safety and Efficacy of Chemokine Modulation to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using chemokine modulation therapy before treatment with pembrolizumab (Keytruda®).

Who is this for?

Women 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 the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Interferon Alfa-2b, by IV, 3 times over 2 weeks </li> <li class="seamTextUnorderedListItem">Rintatolimod, by IV, 3 times over 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 2 years</li> <li class="seamTextUnorderedListItem">2 biopsies (before treatment and during treatment)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. It is approved to treat at least 10 different types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Small proteins called chemokines help get the immune cells to specific organs. </li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®), recombinant interferon alfa-2b, and rintatolimod (Ampligen) each works in a different way to get chemokines to an organ. </li> <li class="seamTextUnorderedListItem">Chemokine modulation therapy may make Keytruda more effective.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03599453' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/rintatolimod' target='_blank'>NCI Drug Dictionary: Rintatolimod</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-interferon-alfa-2b' target='_blank'>NCI Drug Dictionary: Interferon Alfa-2b</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/celecoxib' target='_blank'>NCI Drug Dictionary: Celecoxib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pembrolizumab' target='_blank'>NCI Drug Dictionary: Pembrolizumab</a> </li></ul>

103

NEAREST SITE: 2384 miles
Duke University
Durham,NC

VISITS: At least 1 visit every month, ongoing

PHASE: II

NCT ID: NCT03167619

Durvalumab & Olaparib in Advanced Triple Negative Breast Cancer Treated with Chemotherapy

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) Scientific Title

Purpose

To compare the effects (good and bad) of using the targeted therapy olaparib (Lynparza®) alone or with an immunotherapy drug.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer, already treated with at least four cycles of a platinum-based chemotherapy, and who have had no more than two prior chemotherapies for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfizi®), by IV, once every month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lynparza is approved to treat HER2-negative metastatic breast cancer in patients who test positive for an inherited BRCA mutation. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor, a drug that blocks the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. </li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. </li> <li class="seamTextUnorderedListItem">It has been approved to treat certain other types of cancers, and 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/NCT03167619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ex&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>AstraZeneca Information Page: Imfinzi</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/durvalumab-improves-survival-in-stage-iii-nsclc' target='_blank'>Oncolive: Durvalumab/Olaparib Combo Is Active in BRCA-Mutated Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

104

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: 1 visit per month, ongoing

PHASE: II

NCT ID: NCT03394027

ONC201 for Estrogen Receptor Positive or Triple Negative Metastatic Breast Cancer

A Phase 2 Study of ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma Scientific Title

Purpose

To examine the safety and effectiveness of using an experimental drug called ONC201 to slow cancer growth.

Who is this for?

People with estrogen receptor positive or triple negative (ER-, PR- and HER2-) metastatic breast cancer. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONC201, by mouth, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Two biopsies, before starting treatment and 5 weeks after</li></ul>
<ul class="seamTextUnorderedList"> <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/NCT03394027' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://oncoceutics.com/onc201-trial-begins-endometrial-breast-cancer/' target='_blank'>oncoceutics: ONC201 Trial Begins for Endometrial and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/akt-erk-inhibitor-onc201' target='_blank'>cancer.gov: Akt/ERK inhibitor ONC201</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.eurekalert.org/pub_releases/2018-05/rp-okb050818.php' target='_blank'>EurekAlert: ONC201 kills breast cancer cells in vitro by targeting mitochondria</a> </li></ul>

105

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda,MD

VISITS: Visits every 2 weeks for 1 year

PHASE: I-II

NCT ID: NCT02484404

MEDI4736 with Lynparza or Cediranib for Advanced Breast (and Other Solid) Tumors

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using MEDI4736 and Lynparza, when given together.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is triple negative and for whom no currently available treatment exists. You must not have received more than three prior therapies for metastatic disease. Full eligibility criteria

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Participants will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li></ul>
Durvalumab (MEDI4736) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. </li> <li class="seamTextUnorderedListItem">Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02484404' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02484404?term=NCT02484404&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=740856' target='_blank'>NCI Drug Dictonary: MEDI4736</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=560191' target='_blank'>NCI Drug Dictonary: Olaparib</a> </li></ul>

106

NEAREST SITE: 2494 miles
Lehigh Valley Health Network
Allentown,PA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03808337

Stereotactic Body Radiotherapy (SBRT) Combined with Standard of Care Treatment for Metastatic Breast Cancer

A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer Scientific Title

Purpose

To compare the effects (good and bad) of using stereotactic body radiotherapy (SBRT) along with a standard of care treatment to a standard of care treatment alone.

Who is this for?

People with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-). 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">Stereotactic Body Radiotherapy (SBRT)</li> <li class="seamTextUnorderedListItem">Standard of care determined by your physician</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care determined by your physician</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SBRT can be used to deliver precise, intense doses of radiation to specific places where the cancer has spread. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of metastatic cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03808337' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/radiotherapy/external/types/stereotactic-body-radiotherapy-sbrt' target='_blank'>CancerResearchUK: Stereotactic Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uclahealth.org/radonc/faqs-sbrt' target='_blank'>UCLA Health: SBRT FAQs</a> </li></ul>

107

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

VISITS: Visits 5 days a week for 3 weeks

PHASE: II

NCT ID: NCT02422498

Predicting Response to Cisplatin & Radiation in Advanced Triple Negative Breast Cancer

A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy Scientific Title

Purpose

To evaluate how well a test done on a biopsy sample predicts response to cisplatin and radiation therapy.

Who is this for?

Women with recurrent (some stage III) or metastatic (stage IV) breast cancer that is triple negative. The biopsy and radiation will be given at Memorial Sloan Kettering Cancer Center. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®), by IV, once a week for 1-2 weeks</li> <li class="seamTextUnorderedListItem">Followed by radiation therapy, 5 days a week for 3 weeks</li></ul>
Researchers are studying the best way to treat triple-negative (ER-, PR-, HER2-) breast cancer. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy drug being studied in patients with triple-negative breast cancer. </li> <li class="seamTextUnorderedListItem">Radiation therapy can be used to treat cancer cells that have spread to different parts of the body. </li> <li class="seamTextUnorderedListItem">Researchers have developed a test that they think can be used to predict how well a patient's tumor will respond to concurrent cisplatin and radiation therapy. </li> <li class="seamTextUnorderedListItem">The test is performed on a biopsy (tissue sample) of the tumor, taken from the breast or elsewhere in the body.</li> </ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02422498' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tnbcfoundation.org/state-of-the-art-tnbc-treatment-brochure/' target='_blank'>TNBC Foundation</a> </li></ul>

108

NEAREST SITE: 2539 miles
Memoral Sloan Kettering Basking Ridge
Basking Ridge,NJ

VISITS: 1 visit every other day for 6 or 10 days, then coincides with standard treatment

PHASE: II

NCT ID: NCT03808662

SBRT Radiation Therapy for Patients With Oligoprogressive Metastatic Breast Cancer

A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Metastatic Breast and Lung Cancer Patients With Oligoprogressive Disease Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases.

Who is this for?

People with oligoprogessive metastatic (stage IV) triple negative (ER-, PR- and HER2-) or hormone receptor positive (ER+ and/or PR+) breast cancer that has progressed on at least one other systemic treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), every other day, for 3 or 5 sessions</li> <li class="seamTextUnorderedListItem">followed by standard of care treatment (decided by you and your physician)</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment (decided by you and your physician)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patients with oligoprogressive metastatic breast cancer have a small number of metastatic tumors in one or two other parts of the body. </li> <li class="seamTextUnorderedListItem">This study will compare the safety and effects (good or bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases followed by a standard of care treatment, to a standard of care treatment alone. </li> <li class="seamTextUnorderedListItem">SBRT uses multiple radiation beams to deliver high doses of precision radiation directly to the tumor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03808662' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uclahealth.org/radonc/faqs-sbrt' target='_blank'>UCLA Health: SBRT FAQs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/diagnosis-treatment/cancer-treatments/radiation-therapy/what-sbrt' target='_blank'>MSKCC: What is SBRT?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/oligometastasis' target='_blank'>NCI Defintion: Oligometastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/clinical-trials/18-431' target='_blank'>MSKCC: Study information</a> </li></ul>

109

NEAREST SITE: 2566 miles
Memorial Sloan Kettering Monmouth
Middletown,NJ

VISITS: 4 visits over the first 2 months, then monthly visits thereafter

PHASE: I-II

NCT ID: NCT02605486

Ibrance & Casodex for Metastatic Triple Negative Breast Cancer with Androgen Receptors

Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) Scientific Title

Purpose

To look at the safety and effects (good and bad) of using Ibrance and Casodex for triple negative breast cancer.

Who is this for?

Women with metastatic (stage (IV) breast cancer that is triple negative. Full eligibility criteria

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All participants will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) by mouth daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) by mouth daily for 3 weeks on, followed by 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a targeted therapy that keeps cancer cells from growing by blocking two enzymes, CDK 4 and CDK 6. It is used to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer. </li> <li class="seamTextUnorderedListItem">Some breast cancers contain androgen receptors. Laboratory studies suggest these tumors may respond to anti-androgen treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02605486' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02605486?term=NCT02605486&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/targeted_therapies/ibrance' target='_blank'>Breastcancer.org: Ibrance</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/cancer-drugs/bicalutamide' target='_blank'>Cancer Research UK: Bicalutamide</a> </li></ul>

110

NEAREST SITE: 2567 miles
Mount Sinai Downtown
New York,NY

VISITS: Visits every 3 weeks

PHASE: II

NCT ID: NCT02531932

Carboplatin and Afinitor for Metastatic Triple-Negative Breast Cancer

A Multi-Centered Randomized Phase II Study Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer Scientific Title

Purpose

To compare the safety and effects (good and bad) of Carboplatin and Afinitor to Carboplatin alone.

Who is this for?

People with metastatic (stage IV) breast cancer that is triple negative. Full eligibility criteria

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Participants will be randomly assigned to 1 of 2 groups: Group 1: Intervention <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, every 3 weeks</li></ul>
Paraplatin (Carboplatin®) is a platinum-based chemotherapy drug used to treat metastatic breast cancer that has not responded to previous treatments. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02531932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tnbcfoundation.org/tnbcnews-afinitor/' target='_blank'>TNBC Foundation: Afinitor and Carboplatin for Advanced TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancernetwork.com/news/new-approaches-triple-negative-breast-cancer' target='_blank'>CancerNetwork: New Approaches for TNBC</a> </li></ul>

111

NEAREST SITE: 2568 miles
NYU Perlmutter Cancer Center
New York,NY

VISITS: Visits weekly

PHASE: NA

NCT ID: NCT02752685

Keytruda and Abraxane in HER2 Negative Metastatic Breast Cancer

Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety and effects of using a chemotherapy drug along with Keytruda immunotherapy.

Who is this for?

Women with metastatic (stage IV) breast cancer that is either triple negative (ER-, PR-, HER2-) or estrogen receptor positive and HER2 negative. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Taxotere®), by IV, weekly, 2 weeks on 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are trying to see which treatment combinations are best for HER2-negative breast cancer. </li> <li class="seamTextUnorderedListItem">The chemotherapy drug is nab-paclitaxel (Abraxane®), which is used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®), which gets the immune system to fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02752685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT02752685?term=NCT02752685&rank=1' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li></ul>

112

NEAREST SITE: 2569 miles
Icahn School of Medicine at Mount Sinai
New York,NY

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03709446

Leflunomide in Previously Treated Metastatic Triple Negative Breast Cancer

A Phase I/II Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers Scientific Title

Purpose

To determine the safety and effects (good and bad) of leflunomide (Arava®), an oral drug that blocks dihydroorotate dehydrogenase (DHODH).

Who is this for?

Women with metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer who have had no more than 2 chemotherapy drugs used to treat metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leflunomide (Arava®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leflunomide (Arava®) is approved to treat certain adults with rheumatoid arthritis.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03709446' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncologynurseadvisor.com/home/cancer-types/breast-cancer/immunosuppressor-inhibits-metabolic-pathway-in-breast-cancer-kills-cancer-cells/' target='_blank'>Oncology Nurse Advisor: Immunosuppressor Inhibits Metabolic Pathway in Breast Cancer, Kills Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/leflunomide-oral-route/description/drg-20067158' target='_blank'>Mayo Clinic: Leflunomide</a> </li></ul>

113

NEAREST SITE: 2614 miles
Yale University Cancer Center
New Haven,CT

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03917381

Immunotherapy GEN1046 in Metastatic Triple Negative Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors Scientific Title

Purpose

To find the best dose and study the effects (good and bad) of the experimental immunotherapy GEN1046.

Who is this for?

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

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You will receive GEN1046, by IV, every 3 weeks
<ul class="seamTextUnorderedList"> <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/NCT03917381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genmab.com/product-pipeline/products-in-development' target='_blank'>Drug Company Information Page: GEN1046</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2018/10/03/mbc-news-4/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>

114

NEAREST SITE: 2614 miles
Yale School of Medicine
New Haven,CT

VISITS: Hospital stay for at least 3 weeks

PHASE: II

NCT ID: NCT04111510

T-Cell Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Pretreated Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of the T-cell immunotherapy LN-145.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least one but no more than three lines of chemotherapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy of your tumor (about 3 weeks before treatment)</li> </ul> During hospital stay <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nonmyeloablative lymphodepletion (chemotherapy), daily, for 1 week</li> <li class="seamTextUnorderedListItem">LN-145, by infusion, once</li> <li class="seamTextUnorderedListItem">Interleukin-2 (IL-2), by IV, up to 6 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T lymphocytes are a natural part of your immune system and a T lymphocyte that has entered a cancer cell is called a Tumor Infiltrating Lymphocyte (TIL). </li> <li class="seamTextUnorderedListItem">From the biopsy of your tumor, researchers will remove TILs, and then in a laboratory make copies. </li> <li class="seamTextUnorderedListItem">The copies (LN-145) will be infused into your body during your hospital stay. </li> <li class="seamTextUnorderedListItem">After the infusion of LN-145, you will receive up to 6 doses of interleukin 2 (IL-2) to help the immune system.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04111510' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/autologous-tumor-infiltrating-lymphocytes-ln-145' target='_blank'>NCI Drug Dictionary: LN-145 (Autologous Tumor Infiltrating Lymphocytes LN-145)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cellular-therapy' target='_blank'>NCI Dictionary of Cancer Terms: Adoptive Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medicine.yale.edu/ycci/trial/6876/' target='_blank'>Yale University: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.iovance.com/clinical/our-clinical-program/' target='_blank'>Immunotherapy Company Information Page: How Adoptive Cell Therapy Works</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>NCI Cancer Treatment: T-Cell Transfer Therapy</a> </li></ul>

115

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03130439

Abemaciclib in Advanced Triple Negative Breast Cancer with the Rb Protein

A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of abemacicilb, a CDK inhibitor, in patients with advanced triple negative breast cancer.

Who is this for?

People with triple negative advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have a tumor that tests positive for the retinoblastoma (Rb) protein. The researchers will test your tumor for this protein. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (LY2835219), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The target drug used in this trial is abemaciclib (LY2835219). It is a CDK4/6 inhibitor. </li> <li class="seamTextUnorderedListItem">Studies have found that the Rb protein, which can help stop tumors from growing, doesn't work properly in certain cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Rb</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03130439' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.targetedonc.com/conference/asco-2014/Cell-Cycle-Inhibitor-Slows-Metastatic-Breast-Cancer' target='_blank'>Targeted Oncology: Abemaciclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://externalmediasite.partners.org/Mediasite/Play/f901a457a7924768b215636596e569f41d' target='_blank'>Dana-Farber Cancer Institute: Patient-friendly informational video about this trial</a> </li></ul>

116

NEAREST SITE: 2693 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: Weekly visits for 2 out of every 3 weeks

PHASE: I-II

NCT ID: NCT04039230

Sacituzumab Govitecan and Talazoparib for Metastatic Triple Negative Breast Cancer

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer Scientific Title

Purpose

To evaluate the safety, best dose, and effects (good and bad) of using a PARP inhibitor in combination with sacituzumab govitecan.

Who is this for?

Women 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">Talazoparib (Talzenna®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (IMMU-132), by IV, once a week, for 2 out of every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is talazoparib (Talzenna®). It is approved to treat patients with an inherited BRCA 1 or BRCA 2 mutation who have advanced triple negative breast cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (IMMU-132) has been approved for use in some people with metastatic triple negative breast cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan is an antibody-drug conjugate (ADC). This type of drug 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 TROP2 proteins. 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/NCT04039230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sacituzumab-govitecan' target='_blank'>NCI Drug Dictionary: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/news/april-2020/fda-approves-sacituzumab-govitecan-hziy-for-patients-with-previously-treated-metastatic-triple-negative-breast-cancer/' target='_blank'>ASCO: FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunomedics.com/sacituzumab-govitecan-immu-132/' target='_blank'>Drug Company Information Page: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109819878' target='_blank'>Pfizer Oncology: Talzenna™</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: ADCs in Breast Cancer</a> </li></ul>

117

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

VISITS: Weekly visits for 5 weeks, then every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03362060

PVX-410 Vaccine plus Keytruda for HLA-A2+ Advanced Triple Negative Breast Cancer

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study whether a new immunotherapy called PVX-410 is a possible treatment for metastatic triple negative breast cancer patients who are HLA-A2+.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that is found by the research team to test positive for the HLA A2 protein. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVX-410 vaccine, by IV, weekly for 5 weeks </li> <li class="seamTextUnorderedListItem">Followed by 2 booster vaccines 5 weeks after receiving the first vaccine, every 4 months </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVX-410 is a new type of vaccine that may help the immune system find and attack cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy drug called a PD-1 inhibitor that has been approved to treat some cancer types, including breast cancer. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1).</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA A2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03362060' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/whats-new-in-immunotherapy-research.html' target='_blank'>Cancer.org: What's New in Cancer Immunotherapy Research?</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncopep.com' target='_blank'>Drug Company Information Page: PVX-410</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li></ul>

118

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

VISITS: Visits every 3 week, ongoing

PHASE: II

NCT ID: NCT03483012

Tecentriq and Stereotactic Radiosurgery for Triple Negative Breast Cancer Brain Mets

A Phase II Study of Atezolizumab in Combination With Stereotactic Radiosurgery for Patients With Triple-negative Breast Cancer and Brain Metastasis Scientific Title

Purpose

To investigate the effectiveness of treating breast cancer brain metastases with stereotactic radiosurgery and an immunotherapy drug.

Who is this for?

Women with metastatic (stage IV) breast cancer that is triple negative and spread to the brain. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS) within 2 weeks after brain MRI</li></ul>
Stereotactic radiosurgery delivers focused radiation to each individual brain metastasis. It is routinely used to treat brain metastases. <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug being used in this study is atezolizumab (Tecentriq®). It gets the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death ligand-1). It is approved to treat certain types of bladder cancer 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/NCT03483012' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/types/recur_metast/treat_metast/options/local/brain/radiosurgery' target='_blank'>Breastcancer.org: Stereotactic Radiosurgery for Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech: Tecentriq</a> </li></ul>

119

NEAREST SITE: 2694 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: