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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: September 27, 2020)
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Treatment
BRCA1/2 (inherited)
Chemotherapy
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Radiation Oncology
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Surgery: Reconstruction
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
Click here to view online studies and trials that do not require site visits
1
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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<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>
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<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>
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<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>
2
NEAREST SITE: 27 miles
Stanford University School of Medicine
Stanford,CA
VISITS: 1 visit
PHASE: NA
NCT ID: NCT01034033
How Cancer Develops in Women With BRCA1/2 or Other Genetic Mutations
Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples Scientific Title
Purpose
To analyze blood samples from women at high risk of developing breast cancer in order to learn more about how cells change over time from normal to cancerous
Who is this for?
Women at high-risk for developing breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> All participants will provide blood samples.</p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BRCA 1 and BRCA 2 are tumor suppressor genes.</li> <li class="seamTextUnorderedListItem">Inheriting a mutation in the BRCA 1 or BRCA 2 gene increases cancer risk.</li> <li class="seamTextUnorderedListItem">For the cancer to develop, though, the cells will need to first acquire other mutations.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01034033' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://stanfordhealthcare.org/medical-conditions/cancer/hboc/brca-1-and-2.html' target='_blank'>Stanford Health Care: BRCA1 and BRCA2 Genes</a> </li><li class='seamTextUnorderedListItem'><a href='https://brightpink.org' target='_blank'>Bright Pink: Breast and Ovarian Health Organization</a> </li></ul>
3
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 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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<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>
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<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>
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<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>
4
NEAREST SITE: 273 miles
Sansum Clinic
Santa Barbara,CA
VISITS: 3 visits over 3 months
PHASE: NA
NCT ID: NCT04436120
Next Generation Sequencing for Advanced HER2- Breast Cancer After Disease Progression
TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE) Scientific Title
Purpose
To compare the genetics of your cancer before and after you receive a targeted therapy to study why your cancer stopped responding to treatment and to help you decide which therapy or clinical trial you should try next.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-), hormone positive (ER+ and/or PR+) breast cancer or HER2 negative (HER2-) breast cancer with an inherited BRCA 1 or BRCA 2 mutation. Your cancer must have progressed while receiving palbociclib (Ibrance®) or a PARP inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy (tissue sample) of your tumor</li> <li class="seamTextUnorderedListItem">Blood draw</li> <li class="seamTextUnorderedListItem">Results of the Next Generation Sequencing (gene panel tests of your tumor and blood)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Next Generation Sequencing (NGS) is gene panel testing of your blood and tumor. </li> <li class="seamTextUnorderedListItem">NGS is a type of comprehensive genomic testing. Genomic testing looks at genetic mutations within your tumor.</li> <li class="seamTextUnorderedListItem">This information may help you and your doctor decide which therapy or clinical trial is right for you. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04436120' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/science/find-a-trial/nct04436120' target='_blank'>Pfizer Clinical Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/testing/types/broad-molecular-profiling-tests' target='_blank'>Breastcancer.org: Broad Molecular Profiling Tests</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/899785' target='_blank'>Medscape: Should Every Metastatic Breast Cancer Patient Undergo Next-Generation Sequencing?</a> </li></ul>
5
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 Ceralasertib in Metastatic Triple Negative Breast Cancer
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 effects (good and bad) of using olaparib (Lynparza®) alone to using olaparib (Lynparza®) in combination with the experimental targeted therapy ceralasertib (AZD6738).
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 two lines of chemotherapy for metastatic disease.
Full eligibility criteria
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<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</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Ceralasertib (AZD6738), by mouth, once a day (1 week on, 3 weeks off)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">While your tumor will be tested for mutations in genes that are part of the homologous recombination repair (HRR) pathway, which includes BRCA 1/2, a mutation in the HRR pathway is not required for enrollment. </li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. It is approved for use in metastatic inherited BRCA1/2 mutation, HER2 negative breast cancer. </li> <li class="seamTextUnorderedListItem">Ceralasertib (AZD6738) is an experimental targeted therapy drug that targets DNA damage repair.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HRR (homologous recombination repair) pathway, BRCA 1, BRCA 2</li></ul>
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<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'>AstraZeneca Drug Information Page: Lynparza</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: Ceralasertib</a> </li></ul>
6
NEAREST SITE: 666 miles
University of Washington Medical Center
Seattle,WA
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT02993068
Stand up to Cancer: Making Genetic Testing Accessible
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible) Scientific Title
Purpose
To study four approaches to providing education about genetic risk for cancer.
Who is this for?
Women, age 30 or over, with at least one ovary, a history of breast cancer or considered at high risk for breast cancer, and planning to be tested for a breast cancer-related genetic mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video before the testing</li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video before the genetic testing </li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report with telephone genetic counseling</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video with telephone genetic counseling before the testing</li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report with telephone genetic counseling </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Watch an online educational video with telephone genetic counseling before the testing</li> <li class="seamTextUnorderedListItem">Mail in the saliva collection kit </li> <li class="seamTextUnorderedListItem">Receive an online test results report</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The researchers will see what effects the programs have on a woman's understanding of genetics and quality of life.</li> <li class="seamTextUnorderedListItem">The study is using FDA-approved saliva-testing kits and genetic tests.</li> <li class="seamTextUnorderedListItem">To be eligible for this study, you must meet one of the following: diagnosed with breast cancer at 45 or younger; diagnosed with triple negative (ER-, PR-, HER2-) breast cancer at 60 or younger; have one blood relative with a mutation in BRCA 1, BRCA 2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2; have one relative with ovarian cancer; have at least 2 relatives with breast cancer on the same side of the family, one of which is 50 years of age or less; or have one male relative with breast cancer.</li> <li class="seamTextUnorderedListItem">Any woman who tests positive for a genetic mutation will have the ability to speak with a genetic counselor.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02993068' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://magenta.mdanderson.org' target='_blank'>MD Anderson Cancer Center Study Information: MAGENTA</a> </li></ul>
7
NEAREST SITE: 1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays,KS
VISITS: 1 visit
PHASE: NA
NCT ID: NCT02302742
A Registry for People with Triple Negative Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations
PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT) Scientific Title
Purpose
To learn more about the relationship between genetic mutations and cancer outcomes.
Who is this for?
People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> This is a data collection (registry) study. You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA 1 and BRCA 2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>
8
NEAREST SITE: 1509 miles
University of Texas Southwestern Medical Center
Dallas,TX
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT04041128
PARP Inhibitor Before Surgery in Women with Triple Negative Breast Cancer & Inherited BRCA1/2 Mutation
Pre-Surgical Window Pilot Investigation of the Effect of PARP Inhibition on the Cellular and Molecular Changes in Primary Ovarian and Breast Cancer Scientific Title
Purpose
To study the effect that olaparib (Lynparza®) has on breast cancer cells when it is given before surgery.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR- and HER2-) breast cancer who have an inherited BRCA 1/2 mutation and who have not received any other breast cancer therapies.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, for 7 days before surgery</li> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor that is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA mutation. </li> <li class="seamTextUnorderedListItem">This study is also enrolling women with ovarian cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04041128' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/breast-cancer/how-lynparza-treats-breast-cancer.html' target='_blank'>AstraZeneca Drug Information Page: Lynparza® (Olaparib)</a> </li></ul>
9
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04090567
PARP Inhibitor Olaparib with Cediranib or Ceralasertib for Women with Advanced, HER2-, Inherited BRCA+ Breast Cancer
Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced Breast Cancer Scientific Title
Purpose
To study the anti-cancer activity and safety of combining the PARP inhibitor olaparib (Lynparza®) with an experimental targeted therapy--either cediranib or ceralasertib.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-), inherited BRCA positive (BRCA1/2+) breast cancer.
Full eligibility criteria
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<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</li> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth, daily (one week on, three weeks off)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP) and is already approved for use in women with metastatic, HER2-negative, inherited BRCA1/2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Cediranib is a tyrosine kinase inhibitor, a type of targeted therapy, that is designed to block the VEGF (vascular endothelial growth factor receptor) protein. </li> <li class="seamTextUnorderedListItem">Tumors use VEGF to grow new blood vessels. </li> <li class="seamTextUnorderedListItem">Research suggests VEGF inhibitors may slow or stop cancer cell growth. Giving cediranib with olaparib may also make the olaparib more effective. </li> <li class="seamTextUnorderedListItem">Ceralasertib is a new type of targeted therapy called an ATR inhibitor. It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04090567' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Lynparza</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cediranib' target='_blank'>Wikipedia: Cediranib</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: Ceralasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/nejmoa1706450' target='_blank'>Journal Article: Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lynparza-brca-treatment/' target='_blank'>Metastatic Trial Talk: Treating BRCA1/2 Metastatic Breast Cancer</a> </li></ul>
10
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 HER2 Negative, Inherited BRCA1/2+ or Triple 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 who have an inherited BRCA1 or BRCA2 mutation and HER2 negative (HER2-) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive: </p> <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>
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<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> <li class="seamTextUnorderedListItem">Targets or mutations: inherited BRCA 1 and BRCA 2 mutations.</li></ul>
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<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>
11
NEAREST SITE: 2561 miles
Memorial Sloan Kettering Bergen
Montvale,NJ
VISITS: Number of visits unavailable, over 2 years
PHASE: NA
NCT ID: NCT00579488
Identifying Different Types of BRCA1 and BRCA2 Mutations
Clinical Significance of Germline BRCA Mutations Scientific Title
Purpose
To identify the range of BRCA mutations found in people who have genetic testing, to better understand the different types of BRCA1 and BRCA2 mutations that increase cancer risk.
Who is this for?
People, including those without breast cancer, who are planning to have a genetic counseling consultation at Memorial Sloan-Kettering Cancer Center in New York City.
Full eligibility criteria
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<p class="seamTextPara"> All participants will undergo blood tests</p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">People who inherit a mutation in the genes known as BRCA1 and BRCA2 are at increased risk of developing breast cancer. </li> <li class="seamTextUnorderedListItem">To be eligible, participants must have a genetic counseling consultation at Memorial Sloan-Kettering Cancer Center in New York City.</li> </ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT00579488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/all-about-cancer/genetics/genetics-breast-cancer' target='_blank'>Cancer.Net: Genetics of Breast Cancer</a> </li></ul>
12
NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT03641755
Olaparib & Sapacitabine for People with Advanced Breast Cancer & an Inherited BRCA1/2 Mutation
A Phase Ib/II Study of Olaparib With Sapacitabine in BRCA Mutant Breast Cancer Scientific Title
Purpose
To look at the safety, effects (good and bad) and best dose of sapacitabine to use along with olaparib (Lynparza®).
Who is this for?
People with metastatic (stage IV) breast cancer who have been tested for and found to have an inherited BRCA1 or BRCA2 mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Sapacitabine, by mouth, 2 weeks on 2 weeks off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sapacitabine is an investigational chemotherapy taken orally (by mouth). </li> <li class="seamTextUnorderedListItem">Lynparza is a type of targeted therapy known as a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">PARP inhibitors block poly (ADP-ribose) polymerase, an enzyme that plays a role in cancer cell growth. </li> <li class="seamTextUnorderedListItem">Lynparza is approved to treat HER2-negative metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Targets and mutations: inherited BRCA 1 and BRCA 2 mutations</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03641755' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sapacitabine' target='_blank'>NCI Drug Dictionary: Sapacitabine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cyclacel.com/research_programs_oncology_cyc682.shtml' target='_blank'>Cyclacel Pharmaceuticals Drug Information Page: Sapacitabine</a> </li></ul>
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BRCA Gene Mutations in Latinas and Hispanic Women with Breast Cancer
BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects Scientific Title
Purpose
To study how common BRCA1 and BRCA2 mutations are among Hispanic women and Latinas with breast cancer.
Who is this for?
Women with stage I, stage II, stage III or metastatic (stage IV) breast cancer who are Hispanic or Latina.
Full eligibility criteria
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<p class="seamTextPara"> All participants will: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Provide a saliva sample </li> <li class="seamTextUnorderedListItem">Complete a questionnaire </li> <li class="seamTextUnorderedListItem">Provide a copy of pathology report</li> </ul> <p class="seamTextPara"> No study visits are required. The consent process can be done by phone (in English or Spanish) and the questionnaire and saliva collections completed by U.S. mail.</p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some women who have triple negative (ER-, PR-, HER2-) breast cancer also have a BRCA 1 or BRCA 2 genetic mutation.</li> <li class="seamTextUnorderedListItem">The number of Hispanic women and Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is unknown. </li> <li class="seamTextUnorderedListItem">Learning more about BRCA1/2 mutation rates among Latinas and Hispanic women will help researchers provide better treatment.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01251900' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA' target='_blank'>NCI: BRCA Mutations</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Gene Mutations</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/TripleNegativeBreastCancer.html' target='_blank'>Susan G. Komen: Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/espanol/tipos/seno' target='_blank'>NCI: Cá¡ncer de seno</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/espanol/cancer/cancerdeseno/' target='_blank'>American Cancer Society: Cá¡ncer de seno</a> </li></ul>
