Talazoparib for People with Metastatic Breast Cancer Who Have Acquired (Somatic) BRCA Mutations
Clinicaltrials.gov identifier:
NCT03990896
Treatment
This is a study for people with metastatic breast cancer without a known mutation in BRCA1 or BRCA2, who learn they have a BRCA1 or BRCA2 acquired tumor mutation (somatic mutation) found through liquid biopsy
Study Contact Information:
The study principal investigator, Dr. Neelima Vidula can be contacted at 617-726-6500.
The overall study coordinator, Erin Basile can be contacted at 617-724-5059.
Talazoparib for People with Metastatic Breast Cancer Who Have Acquired (Somatic) BRCA Mutations
About the Study
This is a study for patients with breast cancer without a known mutation in or , who learn they have a BRCA1 or BRCA2 acquired tumor mutation () found through . Patients are treated with , a well-tolerated oral that targets the BRCA1/2 mutation to determine whether this treatment (which is already approved for people with an inherited BRCA1/2 mutation) is effective in this population.
Type of Study
This is a phase 2, , single arm, multi-center clinical trial evaluating talazoparib in patients with metastatic breast cancer who have somatic BRCA1/2 mutations detectable in cell-free . Patients with triple-negative () or hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer are eligible. Patients are treated with talazoparib until disease progression, unacceptable , or withdrawal of consent.
- This is an open-label, single arm study so all patients get the same study treatment (talazoparib).
What the Study Entails
- Initial screening for study (baseline blood work, CT scans and bone scan, visit, consent, etc.)
- Treatment with talazoparib, an oral therapy, until disease progression, toxicity, or withdrawal of consent. Talazoparib is already approved for BRCA1/2 carriers.
- Blood draw every 4 weeks for organ function assessment and to evaluate changes in cell-free DNA (liquid biopsy) with treatment.
- CT Chest, abdomen, and pelvis and bone scan every 12 weeks while on treatment.
California
City: San Francisco RECRUITING
Facility: UCSF Medical Center-Mission Bay/Benioff Children's Hospital
Contact Info:
hope.rugo@ucsf.edu
415-353-7070
Hope Rugo, MD
Georgia
City: Atlanta RECRUITING
Facility: Emory University Winship Cancer Institute
Contact Info:
manali.ajay.bhave@emory.edu
404-778-3969
Manali Bhave, MD
Illinois
City: Chicago RECRUITING
Facility: Northwestern University
Contact Info:
lflaum@nm.org
630-886-6967
Lisa Flaum, MD
Massachusetts
City: Boston RECRUITING
Facility: Massachusetts General Hospital Cancer Center
Contact Info:
nvidula@mgh.harvard.edu
617-724-4000
Neelima Vidula, MD
New York
City: New York RECRUITING
Facility: Weill Cornell Medicine
Contact Info:
mac9795@med.cornell.edu
646-962-2330
Massimo Cristofanilli, MD
Tennessee
City: Nashville RECRUITING
Facility: Vanderbilt University
Contact Info:
vandana.abramson@vumc.org
615-936-3831
Texas
City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
sdamodaran@mdanderson.org
713-792-2817
Senthil Damodaran, MD, PhD
Patients may participate if they have the following:
- metastatic breast cancer
- If they have TNBC they must have received at least 1 prior line of chemotherapy (any number of prior therapies are allowed), OR
- If they have HR+/HER2- breast cancer, they must have received at least 1 prior hormone therapy (or considered inappropriate for hormone therapy) in the metastatic setting
- a liquid biopsy test (cell-free DNA testing) , which found an acquired (somatic) BRCA1 or BRCA2 mutation
- Patients are not required to have had prior genetic testing for an inherited BRCA1/2 mutation. However, those patients who have completed genetic testing and have an inherited BRCA1/2 mutation are not eligible.
- adequate organ function
- Patients are excluded if they have an inherited BRCA1 and BRCA2 mutation.
- Patients are excluded if they have received a PARP inhibitor in the past.