Trial Seeks Participants With Metastatic Breast Cancer and BRCA1/2 Mutations

Nearly 250 women and men needed for study of new PARP inhibitor
Featured Clinical Trials
January 6, 2014
By: 
Nicole Katze, MA, Editor and Manager, Content Development
Reviewed By: 
Shannon L. Puhalla, MD

The BROCADE study needs men and women with metastaticinfo-icon breast cancer and a BRCA1info-icon or BRCA2info-icon geneinfo-icon mutationinfo-icon for a phase II clinical trialinfo-icon. The trial team will assess how safe and effective a new targeted therapyinfo-icon is when combined with one or more common chemotherapyinfo-icon medicines.

The targeted therapy, veliparib, is a new PARP inhibitorinfo-icon, a medicineinfo-icon that targets a certain enzyme needed for cancer cells to grow. An enzyme is a type of proteininfo-icon 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.

PARPinfo-icon 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 carboplatininfo-icon (Paraplatininfo-icon) and paclitaxelinfo-icon (Taxolinfo-icon). All three are chemotherapy medicines approved to treat cancers. The trial team will collect data to analyze progression-free survivalinfo-icon, the time from the start of the study treatment until the disease grows or spreads.

Design

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 
  • Placeboinfo-icon taken by mouth on days 1 through 7, and carboplatin plus paclitaxel on day 3, repeated in 21-day cycles

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.

Eligibility

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 therapyinfo-icon 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 taxaneinfo-icon (such as paclitaxel or docetaxelinfo-icon) for metastatic breast cancer in the past
  • have or had brain metastases

For more information or to find out if you are eligible, talk with your doctor about trial NCT01506609 on ClinicalTrials.gov, or visit the BROCADE website at BROCADEStudy.com.

Study Locations

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.

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Additional Related Topics 
Hereditary
Metastatic
Clinical Trials