Safety and Efficacy of Olaparib Combined with Agents Targeting DNA Damage Repair Compared to Olaparib Alone

NOTE: This study is no longer enrolling patients. 

About the Study

The purpose of this study is to assess the efficacy and safety of treatment with the PARP inhibitor, olaparib combined with the drug Ceralasertib compared with olaparib alone for patients with Triple-Negative Breast Cancer.

The study outcomes will be analyzed for the following three patient populations:

1. Patients with BRCA1 or BRCA2 gene mutations.
2. Patients with mutations in any of the other genes, and no mutation in BRCA1 and no mutation in BRCA2.
3. Patients with no detected tumor mutations in any of the homologous recombination repair (HRR) genes. Homologous recombination is a method that normal cells use to repair damage to DNA.

Type of Study

This is an open label, randomized, two-arm study that will enroll 350 people. 

• The study has two arms. All participants will be placed into one of two groups. 
  • One group of patients will receive olaparib as a single agent. 
  • One group of patients will receive olaparib combined with the drug ceralasertib.
• This is a randomized study, which means that participants will be placed into one of the two groups by chance. Neither patients nor the research doctor will choose the group participants are placed in.
• The study is open-label. All participants will know which group they are assigned to.

What the Study Entails

Eligible patients will be randomized into one of two treatment arms:

• Arm #1: Study participants will take 300mg olaparib orally in 28-day cycles.
• Arm #2: Study participants will take 300mg olaparib orally in a 28-day cycle. These participants will take Ceralasertib 160 mg from Day 1 to Day 7 (inclusive) of every 28-day cycle.

Patients will remain on the study until date of first documented progression of disease or an adverse event that keeps the participant from continuing on the study. 

Study Locations

Sites are also open in Canada and the United Kingdom. 

Principal Investigator

Andrew Tutt, MB ChB PhD
Guy's Hospital, Great Maze Pond, London

NOTE: This study is no longer enrolling patients. 

Patients will be excluded if they:

• have received treatment within 21 days of beginning the study. 
• they received more than 2 prior lines of chemotherapy for metastatic disease.
• they received previous treatment with a PARP inhibitor or other drug that inhibits DNA Damage Response, unless they received the drugs for less than 3 weeks, and it has been at least 12 months since receiving the drug. 
• they have a second primary cancer.
• they have cardiac disease
• they are immunocompromised (e.g., HIV).
• they have active hepatitis B or C.
• they have symptomatic uncontrolled brain metastases.
• they are unable to swallow orally administered medication and/or have gastrointestinal disorders likely to interfere with absorption of the study medication.