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Profile: BRCA1/2+

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Treatment

BRCA1/2 (inherited)

Chemotherapy

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Targeted Therapy: All

Targeted Therapy: Anti-HER2 Therapy

Targeted Therapy: CDK Inhibitors

Targeted Therapy: PARP Inhibitors

Targeted Therapy: Tumor Mutations

Targeted Therapy: Other Targeted Therapy

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AKT

ALK

AR

BARD1

BRCA1/2 (tumor)

BRIP1

CD205

CD70

CHEK2 or CHEK1

ESR1

FGFR

HER2/ERBB2

HLA

MET or C-Met

NTRK

PALB2

PIK3CA or PI3K

PTEN

RAD51

RAF (including BRAF)

RAS (KRAS or NRAS)

RB

ROS1

TP53


1

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
San Francisco, CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03742895

PARP Inhibitor Olaparib for Metastatic Breast Cancer That Tests Positive for a BRCA1/2 Tumor Mutation

A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer Scientific Title

Purpose
To study the safety and anti-cancer activity of using the PARP inhibitor Olaparib (Lynparza®) in cancer with a BRCA1/2 tumor mutation.
Who is this for?
People with metastatic (stage IV) breast cancer that tests positive for a BRCA1 or BRCA2 tumor (not inherited) mutation who have already recieved an anthracycline and a taxane-based chemotherapy. You may not enroll in this trial if you have an inherited BRCA1/2 mutation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations can be inherited (also called germline) or in a tumor (also called somatic). </li> <li class="seamTextUnorderedListItem">This trial is only enrolling people with tumor BRCA1/2 mutations. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer that is BRCA1/2 tumor mutation positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1/2 tumor mutation</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742895' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/results/metastatic-breast-cancer-results.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-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mygenecounsel.com/my-tumor-carries-a-brca-mutation/' target='_blank'>My Gene Counsel: A BRCA Mutation Was Found in My Tumor. Does This Mean I’m a BRCA Carrier?</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/parp-inhibitors-cancer/' target='_blank'>Metastatic Trial Talk: Get the Latest News on PARP Inhibitors</a> </li></ul>
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2

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04171700

PARP Inhibitor Rucaparib in Advanced Breast Cancer that is BRCA+ (Inherited or Tumor) or Tests Positive for Other Mutations

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes (LODESTAR) Scientific Title

Purpose
To look at the safety, effects (good and bad), and anti-tumor activity of the PARP inhibitor rucaparib (Rubraca®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been treated with at least one standard of care therapy but no more than two lines of chemotherapy; and who have inherited (or whose tumor tests positive for) one of the several mutations listed below.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®), by mouth, twice a day, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rucaparib (Rubraca®) is a PARP inhibitor: it blocks poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is approved to treat women with advanced ovarian cancer whose tumors have a BCRA 1 or BRCA 2 mutation. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">People with an inherited BRCA 1 or BRCA 2 mutation and whose tumor is HER2 negative (HER2-) tumor are not eligible for this trial. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1 (tumor or inherited), BRCA2 (tumor or inherited), PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04171700' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rubraca.com/?utm_source=google&utm_medium=cpc&utm_term=rucaparib&utm_campaign=Branded_Alone_GS_EX&gclid=Cj0KCQiAsbrxBRDpARIsAAnnz_OQBEzA3MVbEPTW02l-js4vH6_2yBSOiLDwbWxO914whM6BmwDeWMsaAse7EALw_wcB' target='_blank'>Drug Company Information Page: Rubraca® (Rucaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/02/04/mbc-news-8/' target='_blank'>Metastatic Trial Talk: Get the Latest News on PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncologypro.esmo.org/oncology-in-practice/anti-cancer-agents-and-biological-therapy/parp-inhibition-and-dna-damage-response-ddr/parp-inhibitors/clinical-activity/breast-cancer/ongoing-developments' target='_blank'>ESMO Oncology: PARP Inhibitors in Breast Cancer (HRR Gene Mutations)</a> </li></ul>
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3

NEAREST SITE: 3 miles
Sutter Palo Alto Medical Foundation: San Francisco
San Francisco, CA

VISITS: Coincides with targeted therapy

PHASE: II

NCT ID: NCT02693535

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

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

Purpose
To evaluate the safety and effects (good and bad) of using a tumor's genetic alterations to select an FDA-approved targeted therapy for treatment.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer for whom there is no currently available therapy. You must have results from a genomic or immunohistochemistry test approved by TAPUR.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> Participants will receive an FDA-approved targeted therapy that is chosen based on the tumor's genetic makeup.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's specific genetic profile.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Afatinib, Crizotinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO Study Website: TAPUR</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive: About TAPUR (video)</a> </li></ul>
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4

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

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

PHASE: II

NCT ID: NCT03344965

Olaparib for Metastatic Breast Cancer with Certain Tumor Mutations

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

Purpose
To investigate the safety and effects (good and bad) of using the PARP inhibitor olaparib (Lynparza®) in breast cancer that tests positive for certain mutations.
Who is this for?
People with metastatic (stage IV) breast cancer. You must not have received more than two chemotherapies for metastatic disease and your tumor must test positive for or express one of several markers. (See below for a list of markers).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily, ongoing </li> <li class="seamTextUnorderedListItem">Tumor measurements, every 1.5 months for 6 months, then every 3 months thereafter</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy known as a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">People with inherited BRCA1/2 mutations are not allowed to enroll in this study. </li> <li class="seamTextUnorderedListItem">Targets or mutations: somatic (tumor) BRCA1/2 mutation, ATM, ATR, BARD1, BRIP1 (FANCJ), CHEK2 , FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN, PALB2, RAD50, RAD51C, RAD51D, and other HR-related genes</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03344965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com' target='_blank'>AstraZeneca Drug Information Page: Olaparib</a> </li></ul>
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5

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

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT02849496

Olaparib Alone or With Atezolizumab for People With Advanced HER2 Negative Breast Cancer & an Inherited or Tumor BRCA1/2 Mutation

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 compare the anti-cancer activity of the targeted therapy olaparib (Lynparza®) when it is given alone to when it is given in combination with the immunotherapy atezolizumab (Tecentriq®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer who have an inherited BRCA 1 or BRCA 2 mutation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is approved to treat HER2 negative (HER2-) metastatic breast cancer in women with a BRCA 1/2 genetic mutation.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-LI inhibitor. It works by getting the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death ligand-1). </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is approved for use in advanced triple negative breast cancer. 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/NCT02849496' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com' target='_blank'>AstraZeneca Drug Information Page: Lynparza® (Olaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Drug Information Page: Tecentriq® (Atezolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
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6

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04586335

An Experimental PI3K Inhibitor and a PARP Inhibitor for Advanced Breast Cancer

Open Label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of CYH33, an Oral PI3K Inhibitor in Combination With Olaparib, an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Scientific Title

Purpose
To study the best dose, safety, and anti-cancer activity of giving the experimental PI3K inhibitor CYH33 in combination with the PARP inhibitor olaparib (Lynparza®).
Who is this for?
People with recurrent or metastatic (stage IV) breast cancer who have a tumor that tests positive for or expresses one of several markers. (See below for list of markers.)    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CYH33, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CYH33 is an experimental type of targeted therapy called a PI3K inhibitor.</li> <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">Olaparib is approved to treat HER2-negative metastatic breast cancer in women with a hereditary BRCA gene mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, ATM, CDK12, CHEK1, CHEK2, BARD1, BRIP1, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, PIK3CA hotspot mutations E545X, H1047X, or E542K</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04586335' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.e15645' target='_blank'>ASCO Abstract: CYH33</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Olaparib</a> </li></ul>
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7

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02286687

Talazoparib for Advanced Breast Cancer That Tests Positive for Tumor (Not Inherited) BRCA 1/2 Mutation or Certain Other Mutations

Phase II Study of the PARP Inhibitor BMN 673 (Talazoparib Tosylate) in Advanced Cancer Patients With Somatic Alterations in BRCA1/2, Mutations/Deletions in PTEN or PTEN Loss, a Homologous Recombination Defect, Mutations/Deletions in Other BRCA Pathway Genes and Germline Mutation in BRCA1/2 (Not Breast or Ovarian Cancer) Scientific Title

Purpose
To study the safety and anti-cancer activity of the PARP inhibitor talazoparib (Talzenna®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer whose tumor tests positive for a tumor (not inherited) BRCA mutation or one of several other markers. (See below for a list of markers.) You cannot enroll in this trial if you have an inherited BRCA 1 or BRCA 2 mutation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib® 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">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: tumor (not inherited) BRCA 1 or BRCA 2 mutations, ATM, PALB2, ARID1A, MER11, RAD50, NBS1, or ATR</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02286687' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700051780449266' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li></ul>
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8

NEAREST SITE: 2432 miles
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, MD

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04550494

PARP Inhibitor Talazoparib for Advanced Breast Cancer that Tests Positive for Certain DNA Repair Mutations

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response Scientific Title

Purpose
To study and compare the anti-cancer activity of giving the PARP inhibitor talazoparib (Talzenna®) to people who have already received a PARP inhibitor to people who have never received a PARP inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer whose disease progressed on at least one standard of care therapy for advanced disease and who have inherited (or whose tumor tests positive for) one of the several targets or mutations listed below.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
  • <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 BRCA1 or BRCA2 mutation, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ATM, BACH1 (BRIP1), BARD1, BRCA1/2 (tumor or inherited), CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM and FANCN</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04550494' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700051780449266' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li></ul>
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9

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

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I

NCT ID: NCT03685331

PARP Inhibitor, CDK 4/6 Inhibitor & Fulvestrant for Postmenopausal Women with Advanced, HR+, HER2- Breast Cancer with an Inherited or Tumor BRCA1/2 Mutation

A Phase I/II Trial of Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer Scientific Title

Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of giving together the PARP inhibitor olaparib (Lynparza®), the CDK 4/6 inhibitor palbociclib (Ibrance®) and the anti-estrogen therapy fulvestrant (Faslodex®).
Who is this for?
Postmenopausal women with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2) breast cancer that is BRCA1/2 positive (tumor or inherited) and who have received up to two lines of chemotherapy for metastatic disease.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. It is commonly used with an anti-estrogen therapy for women with metastatic, hormone positive breast cancer. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations can be inherited (also called germline) or in a tumor (also called somatic).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03685331' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://voice.ons.org/news-and-views/germline-and-somatic-mutations-what-is-the-difference' target='_blank'>ONS Voice: Germline and Somatic Mutations, What Is the Difference?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/risk/factors/genetics' target='_blank'>Breastcancer.org: Genetics</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/olaparib.aspx' target='_blank'>Chemocare.com: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a607031.html' target='_blank'>MedLinePlus.gov: Fulvestrant</a> </li></ul>
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10

NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03428802

Immunotherapy Pembrolizumab for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability Scientific Title

Purpose
To study the effects (good and bad) of using the PD-1 inhibitor pembrolizumab (Keytruda®) in breast cancer with a BRCA1/2 tumor mutation.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been tested for and found to have a BRCA 1 or BRCA 2 tumor (not inherited) mutation or a POLE or POLD1 mutation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1/2 tumor (not inherited), POLE, POLD1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03428802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/parp-inhibitor-may-prolong-survival-in-metastatic-brcapositive-breast-cancer' target='_blank'>Cure Today: Parp Inhibitor May Prolong Survival</a> </li></ul>
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11

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03990896

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) BRCA1/2 Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial Scientific Title

Purpose
To study the anti-cancer activity of the PARP inhibitor Talazoparib (Talzenna®) in breast cancer tumors that test positive for a tumor (not inherited) BRCA 1 or BRCA 2 mutation.
Who is this for?
Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Your tumor must test positive for a BRCA 1 or a BRCA 2 tumor (not inherited) mutation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <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> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called germline when they are inherited. </li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called somatic when they are not inherited.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA 1 (tumor), BRCA 2 (tumor)</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03990896' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation' target='_blank'>NCI Drug Dictionary: Somatic Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109817433' target='_blank'>Pfizer Oncology: Talzenna®</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2016/07/how-do-parp-inhibitors-work-in-cancer/' target='_blank'>Dana-Farber Cancer Institue: How Do PARP Inhibitors Work In Cancer? (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2017/vol-18-no-13/blurring-the-lines-between-germline-and-somatic-mutations-in-cancer' target='_blank'>OncLive: Blurring the Lines Between Germline and Somatic Mutations in Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41416-018-0127-5' target='_blank'>Journal Article: BRCA1/2 Testing: Therapeutic Implications for Breast Cancer Management</a> </li></ul>
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