The BROCADE study needs men and women with metastatic breast cancer and a BRCA1 or BRCA2 gene mutation for a phase II clinical trial. The trial team will assess how safe and effective a new targeted therapy is when combined with one or more common chemotherapy medicines.
The targeted therapy, veliparib, is a new PARP inhibitor, a medicine that targets a certain enzyme needed for cancer cells to grow. An enzyme is a type of protein found in all human cells.
Background and Goals
People who have a BRCA1 or BRCA2 gene mutation have an increased risk of developing breast cancer. Mutations, errors in genes, can be passed from parents to children when they are conceived in the womb. Mutations continue to exist because the body’s DNA makes copies of itself, including its errors.
DNA is the basic building block of the human body and contains the information your body’s cells need to keep growing. When DNA is damaged, proteins help fix it so that cells can continue to grow.
PARP inhibitors target the PARP protein, which helps fix damaged DNA in cancer cells. In the lab, cancer cells with BRCA1 and BRCA2 mutations are more sensitive to PARP inhibitors than other cells. When the PARP inhibitor stops the PARP protein from working, the cancer cells die.
BROCADE researchers want to see how well veliparib will work to stop cancer growth when it is given along with temozolomide (Temodar), or with the combination of carboplatin (Paraplatin) and paclitaxel (Taxol). All three are chemotherapy medicines approved to treat cancers. The trial team will collect data to analyze progression-free survival, the time from the start of the study treatment until the disease grows or spreads.
Participants will be assigned to one of three treatment groups:
- Veliparib taken by mouth on days 1 through 7, and temozolomide on days 1 through 5, repeated in 28-day cycles, or
- Veliparib taken by mouth on days 1 through 7, and carboplatin plus paclitaxel on day 3, repeated in 21-day cycles, or
- Placebo taken by mouth on days 1 through 7, and carboplatin plus paclitaxel on day 3, repeated in 21-day cycles
A placebo is an inactive substance.
Participants will stay on the study medicines until the cancer grows or spreads, they choose to leave the study on their own, or side effects become too difficult.
You may be eligible to take part if you
- are 18 years of age or older
- have metastatic breast cancer AND a BRCA1 or BRCA2 gene mutation
- were treated with two or fewer cancer medicines for metastatic breast cancer in the past
- are in generally good health, with good bone marrow, kidney and liver function
You may not be eligible if you
- are pregnant
- had cancer treatment within 21 days, or radiation therapy within 28 days, of starting the trial
- were treated with temozolomide or a PARP inhibitor in the past for breast cancer
- were treated with carboplatin in the past
- were treated with a taxane (such as paclitaxel or docetaxel) for metastatic breast cancer in the past
- have or had brain metastases
This study is being carried out in 82 locations in Australia, Europe, Israel and the United States. For a full list of locations and contact information, visit clinicaltrials.gov.