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1
NEAREST SITE: 27 miles
Stanford Women's Cancer Center
Stanford,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT03499353
Alazoparib Before Surgery in Triple Negative Tumors With an Inherited BRCA Mutation
A PHASE 2, NON-RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI-CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE-NEGATIVE BREAST CANCER Scientific Title
Purpose
To look at the effect that talazoparib (Talzenna®) has on triple negative breast tumors when it is given before surgery.
Who is this for?
People with triple negative (ER-/PR-/HER2-) early stage (stage I, II or IIIA) breast cancer and an inherited BRCA 1/2 mutation and not have had any treatment for your current breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, once a day for 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talzenna is a type of targeted therapy called a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">It is approved to treat patients with an inherited BRCA mutation who have HER2‑negative locally advanced or metastatic breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03499353' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-gbrcam-her2-negative-locally-advanced-or-metastatic-breast-cancer' target='_blank'>FDA: Talazoparib Approval</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/talzenna' target='_blank'>Breastcancer.org: Talzenna</a> </li></ul>
2
NEAREST SITE: 27 miles
Stanford University School of Medicine
Stanford,CA
VISITS: 1 visit
PHASE: NA
NCT ID: NCT01034033
A Study of How Cancer Develops in Women With BRCA1/2 or Other Genetic Mutations
Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples Scientific Title
Purpose
To analyze blood samples from women at high risk of developing breast cancer in order to learn more about how cells change over time from normal to cancerous.
Who is this for?
Women at high-risk for developing breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> All participants will provide blood samples.</p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BRCA1 and BRCA2 are tumor suppressor genes.</li> <li class="seamTextUnorderedListItem">Inheriting a mutation in the BRCA1 or BRCA2 gene increases cancer risk. </li> <li class="seamTextUnorderedListItem">For the cancer to develop, though, the cells will need to first acquire other mutations.</li> </ul>
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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: About Hereditary Breast Ovarian Cancer Syndrome</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT01034033?term=NCT01034033&rank=1' target='_blank'>ClinicalTrials.gov trial info</a> </li></ul>
3
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 genetic education programs.
Who is this for?
Women, 30 or older, who have at least one ovary, who intend to have genetic testing for an inherited mutation that increases breast cancer risk.
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 BRCA1, BRCA2, 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 </li> <li class="seamTextUnorderedListItem">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 MAGENTA Study</a> </li></ul>
4
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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<p class="seamTextPara"> This is a data collection (registry) study. Participants will undergo 1 blood test upon enrolling in this study.</p>
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<p class="seamTextPara"> People who carry an inherited genetic mutation are at increased risk of developing breast cancer. </p> <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>
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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'>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>
5
NEAREST SITE: 1509 miles
University of Texas Southwestern Medical Center
Dallas,TX
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT04041128
PARP Inhibition Before Surgery for Triple Negative And BRCA Mutated Breast Cancer
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 some stage III triple negative (ER-, PR- and HER2-) breast cancer who has an inherited BRCA mutation who have not yet received any other breast cancer treatments.
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'>Lynparza.com</a> </li></ul>
6
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>
7
BRCA Gene Mutations in Latinas with Breast Cancer
BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects Scientific Title
Purpose
To study DNA samples taken from saliva and the medical histories of Latinas who have been diagnosed with breast cancer.
Who is this for?
Women with stage I, stage II, stage III or metastatic (stage IV) breast cancer and who are Hispanic/Latino
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 BRCA1 or BRCA2 genetic mutation.</li> <li class="seamTextUnorderedListItem">The number of Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is not known. </li> <li class="seamTextUnorderedListItem">Learning more about BRCA1/2 mutation rates among Latnas will help researchers provide better treatment to this group of women.</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 Fact Sheet: BRCA1 & BRCA2</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='http://ww5.komen.org/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'>Cancer.gov: Cáncer de seno</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.org/espanol/cancer/cancerdeseno/' target='_blank'>American Cancer Society: Cáncer de seno</a> </li></ul>
