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Trials Seek Participants With Advanced Breast Cancer and a BRCA Mutation

About a thousand people needed for PARP inhibitor studies

Trial starts: October 2013 Trial ends: December 2018

Written By Erin Rowley, Writer and Editorial Coordinator
Reviewed By Mark Robson, MD

Adults with metastatic or locally advanced breast cancer and a BRCA1 or BRCA2 mutation are in demand – three clinical trials, EMBRACA, OlympiAD and BRAVO are testing different PARP inhibitors for safety and effectiveness.

EMBRACA is testing BMN 673, and will need more than 400 participants. OlympiAD is testing olaparib, and will need about 300 participants whose cancer is HER2-negative. BRAVO is testing niraparib, and will need about 300 participants whose cancer is HER2-negative.

Background and Goals

BRCA1 and BRCA2 are genes every person is born with. When either shows mutations, errors in the genes that can be passed from parents to children when they are conceived in the womb, they may increase a person’s risk of developing breast cancer.

PARP inhibitors, also called poly (ADP-ribose) polymerase inhibitors, are targeted therapies that block an enzyme that helps repair DNA damage caused by normal cell activity, UV light, anti-cancer medicines and radiation therapy. PARP inhibitors may cause breast cancer cells to die by stopping the cell from repairing itself when it is damaged. In the lab, cancer cells with BRCA1 and BRCA2 mutations are more sensitive to PARP inhibitors than other cells.

The goal of these trials is to look at whether the PARP inhibitor each is studying is safe and slows or stops disease growth compared to standard chemotherapy medicines. The researchers will measure progression-free survival, or PFS, the length of time during treatment with the study medicine in which the disease does not worsen.

Design

In the EMBRACA trial

  • two thirds of participants will be randomly selected to receive BMN 673 as a daily pill for 21 days.
  • one third will receive standard chemotherapy chosen by you and your doctor.

In the BRAVO trial

  • two thirds of participants will be randomly selected to receive niraparib as three daily pills for 21 days.
  • one third will receive standard chemotherapy chosen by you and your doctor.

In the OlympiAD trial

  • Two thirds of participants will be randomly selected to receive olaparib as two pills taken twice a day for 21 days.
  • One third will receive standard chemotherapy chosen by you and your doctor.

Each study is being conducted at dozens of locations in and outside of the U.S.

These studies are open-label, which means you and your doctor will know which medicine you are taking.

Eligibility

All three studies seek participants who

  • are 18 or older
  • have locally advanced (stage III with lymph nodes involved) or metastatic breast cancer (stage IV)
  • have a BRCA1 or BRCA2 mutation
  • were treated with a taxane or anthracycline chemotherapy in the past
  • are in generally good health

Each trial may have different requirements for participation. Talk with your doctor to find out which trial is best for you.

You may not be eligible if you

  • were treated with a PARP inhibitor in the past
  • have conditions such as HIV or hepatitis C or B, which make it harder for the body to fight infection
  • are allergic in any way to the study medicines

For more information or to find out if you are eligible, talk with your doctor about  NCT01945775 (EMBRACA), NCT02000622 (OlympiAD) and  NCT01905592 (BRAVO), and visit  ClinicalTrials.gov.

Denver, CO  ·  September 13, 2014

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