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Olaparib with Cediranib or Ceralasertib for Advanced BRCA-Mutated Breast Cancer

This study is testing two different drug combinations for women with advanced or metastatic (spread to other parts of the body) breast cancer that has a specific genetic change called a germline BRCA mutation. You may be eligible if your HER2-negative breast cancer has this mutation and you are over 18. The study is comparing olaparib combined with cediranib, and olaparib combined with ceralasertib (also known as AZD6738). These drugs work by blocking enzymes that cancer cells need to grow. The main goal is to see how many patients respond to these treatments. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This is a Phase II interventional study that plans to enroll 60 women. Participants will be randomly assigned to receive one of two drug combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured up to 30 days after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04090567

Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~60 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:CediranibCeralasertibOlaparib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Up to 30 days post treatment

Conditions

Advanced Breast Carcinoma
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Germline BRCA1 Gene Mutation
Germline BRCA2 Gene Mutation
HER2/Neu Negative
Metastatic Breast Carcinoma
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage IV Breast Cancer AJCC v8

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Breast CarcinomaBRCA1 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Banu Arun · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Banu Arun
[email protected]
713-792-2817
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hemoglobin (Hgb) \>/= 10.0 g/dL with no blood transfusion in the past 28 days prior to the administration
Absolute neutrophil count (ANC) \>/= 1.5 x 109/L with no GCSF administration within 28 days prior to administration of study treatment
Platelet count \>/= 100 x 109/L
Total bilirubin \</= 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \</=3.0 x institutional upper limit of normal unless liver metastases are present in which case they must be \</=5x ULN

Exclusion

4cm in diameter, all the following criteria must be met:
An ultrasound (US) within the last 6 months will be required to document that it is \</= 5cm
Patient must be asymptomatic from the aneurysm.
Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \>450 milli-second, or patients with congenital long QT syndrome or family history of unexplained sudden death under 40 years of age
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).

What this trial measures

  • Overall response rate (ORR)Up to 30 days post treatment

    Defined as proportion of patients with reduction in tumor burden (complete response \[CR\] or partial response \[PR\] as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The exact two-sided 95% confidence interval for the ORR will be reported.