Olaparib Plus DNA Damage Repair Targeted Therapy for Metastatic TNBC
Safety and Efficacy of Olaparib Alone Or in Combination with Medication Targeting DNA Damaging Repair for Metastatic Triple Negative Breast Cancer
About the Study
The purpose of this study is to learn the safety and effectiveness of the PARP inhibitor, olaparib as a single drug therapy compared with olaparib in combination with the new agent AZD6738 in patients with metastatic Triple-Negative Breast Cancer (TNBC).
Type of Study
This is a randomized, two-arm, open label study.
- This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in.
- The study has two arms. This means that patients in the study are placed in one of two different groups. One group will received the PARP inhibitor olaparib only and the other group will receive olaparib and AZD6738.
- The study is open-label. All participating patients will know which group they have been assigned to.
Participants will have tumor biomarker testing to look for mutations in genes that called "homologous recombination repair" (HRR) pathway genes. Participants will be divided into three groups based on their tumor biomarker test results:
- Group A: Patients with BRCA1 or BRCA2 gene mutations
- Group B: Patients with mutations in any of the other genes involved in the HRR pathway, and no mutation in BRCA1 and no mutation in BRCA2
- Group C: Patients with no detected tumor mutations in any of the HRR genes
What the Study Entails
Eligible patients will be randomly placed in one of two treatment arms:
- Arm 1: Participants will take oral olaparib twice daily in a 28-day cycle
- Arm 2: Participants will take oral olaparib twice daily in a 28-day cycle and on days 1-7, participants will also take AZD6738 orally daily.
Participants will stay on the study until they have progression of their cancer or an adverse event that requires them to end their participation. Participants will be followed for up to 24 months.
NOTE: Additional study sites can be found on clinicaltrials.gov.
For information about participating at all sites, contact AstraZeneca Clinical Study Information Center by email or phone: 1-877-240-9479.
- Palm Springs
- New Haven
- Kansas City
- New Jersey
- New York
- East Setauket
- Lake Success
- Mount Kisco
- Stony Brook
Andrew Tutt, MB ChB PhD
Guy's Hospital, Great Maze Pond, London
- Males or females, age 18 or older, who meet the following criteria:
- Metastatic triple-negative breast cancer
- Patients must have received at least 1 and no more than 2 prior lines of treatment for metastatic disease with an anthracycline (eg, doxorubicin, epirubicin) and/or a taxane (eg, paclitaxel, docetaxel) unless such chemotherapy drugs were not advised by the medical team
- Tumor testing with Lynparza HRR testing
- At least one site of cancer that can be accurately measured at baseline by CT (or MRI where CT is not advised)
- Life expectancy of 16 weeks or more
People cannot participate if they:
- Received chemotherapy, hormonal or non-hormonal targeted therapy, or radiation within 21 days of starting the study
- More than 2 prior lines of cytotoxic chemotherapy for metastatic disease
- Received previous treatment with a PARP inhibitor (including olaparib) or other DNA Damage Repair inhibitor
- Patients with second primary cancer (with exceptions as defined in the protocol)
- Patients with heart disease
- Are infected with hepatitis B or C or HIV
- Patients with symptomatic uncontrolled brain metastases