Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT03990896
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Talazoparib — DRUGTalazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called "poly (ADP-ribose) polymerases" also called "PARPs". PARPs are proteins (made from genes which are part of DNA) that are found in all normal and cancer cells that are involved in the repair of DNA. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become cancer cells.
Study Details
This research is to evaluate the effectiveness of Talazoparib as a potential treatment for metastatic breast cancer with a BRCA 1 or BRCA 2 mutation.
Key Dates
- Start date
- Nov 18, 2021
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Talazoparib-Talazoparib will be provided as capsules for oral administration daily
Primary Outcome Measure
Median Progression Free Survival [ Time Frame: From the start of treatment until death or disease progression, up to approximately 2 years ]
Central Contacts
- Neelima Vidula, MD617-724-4000
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Medical Center-Mission Bay/Benioff Children's Hospital | San Francisco | California | 94143 | Hope Rugo, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | Manali Bhave, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern University | Chicago | Illinois | 60611 | Lisa Flaum, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | Neelima Vidula, MD (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medicine | New York | New York | 10065 | Massimo Cristofanilli, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University | Nashville | Tennessee | 37232-6307 | |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Senthil Damodaran, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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