Researchers seek 306 people with metastatic, HER2-negative breast cancer and who tested positive for either a BRCA1 or BRCA2 mutation to take part in a treatment study. The trial team will assess the survival benefit and safety of niraparib, an oral PARP inhibitor, compared with physicians’ choice of standard chemotherapy.
Background: PARP Inhibitors and BRCA gene mutations
PARP inhibitors are medicines that work to block an enzyme in the body, known as PARP, from repairing damaged DNA in cancer cells. They may cause cancer cells to die.
In cancers fueled by BRCA mutations, one cell repair pathway is already blocked. When doctors use a medicine to block a second pathway, the cancer cells may die. BRAVO researchers want to find out if blocking the PARP pathway, in particular, is more effective at killing BRCA-positive breast cancers than treatment with chemotherapy alone.
To find out, they will compare outcomes among participants assigned to the two treatment groups. The trial team will measure which group has longer progression-free survival, PFS, the time from the start of trial treatment until the disease grows or spreads. They will also collect data on:
- overall survival, the time from the start of treatment to death from any cause, and
- health-related quality of life, how satisfied participants are with their lives in the context of having and being treated for breast cancer
- includes physical, emotional, mental and social function
Information on the medicine’s safety will be tracked through physical exams and reported side effects.
Participants will be divided into two treatment groups:
- niraparib taken once a day in 21 day cycles, or
- one of four standard-of-care chemotherapy options, as selected by your doctor, given in 21 day cycles
This study is open-label, meaning you and your doctor will know which treatment you receive. To assess health-related quality of life, participants will also be asked to fill out two standard surveys.
You may be able to participate if you
- are over age 18, and have metastatic, HER2-negative breast cancer AND a known BRCA1 or BRCA2 mutation
- If you meet the requirements for BRCA genetic testing, you may join the trial before testing and continue on it if you test positive
- were treated for metastatic breast cancer with no more than 2 chemotherapies in the past
- were treated with an anthracycline (such as doxprubicin) and a taxane (such as paclitaxel) in the past
- If you have hormone-positive disease, it must have progressed on at least one hormonal therapy
- are in generally good health
You may not be eligible if you
- had cancer progress while on platinum-based chemotherapy
- have uncontrolled brain metastases
- have now or had stage IV ovarian cancer; are less than 5 years free of stage III ovarian cancer; or are less than 2 years free of stage II ovarian cancer
- may be hypersensitive to niraparib
- have Hepatitis B or C
- have been treated with a PARP inhibitor in the past
For more information and to find out if you are eligible, talk with your doctor about trial NCT01905592 on ClinicalTrials.gov
This trial is being held in 7 locations in California, Florida, New Mexico, Tennessee, Texas and Washington. For full location details and contact information, see listing NCT01905592 on ClinicalTrials.gov.