A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.
Overview
- Phase
- Phase 3
- Intervention
- Olaparib
- Conditions
- HER2-ve Metastatic Breast Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.
Detailed Description
The study is a phase IIIb, multicenter, single-arm, open-label study designed to evaluate the clinical effectiveness in a real-world setting of olaparib monotherapy in patients with confirmed germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations. This study will generate additional data to support other olaparib studies, which may help inform and guide clinical practice. Physician defined the progression-free survival (PFS) for gBRCAm patients is the primary outcome measure. Based on the prevalence of gBRCA1/2 mutations, it is estimated that up to 1400 patients may require screening in order to identify 250 gBRCA mutated patients and 20 sBRCA mutated patients. Patients will be administered two olaparib 150mg tablets in morning and evening of every day after a light meal. Dose reductions may be required for olaparib treatment related toxicities. Patients should continue to receive study treatment until documented physician-defined disease progression as assessed by the investigator (gBRCA mutated patients), RECIST1.1 disease progression (sBRCA mutated patients) or unacceptable toxicity, or for as long as they do not meet any other discontinuation criteria. A positive benefit/risk profile is expected and no ethical issues are identified from exposing patients to olaparib within the planned clinical study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Olaparib
Olaparib 150mg tablets administered orally twice daily continuously
Intervention: Olaparib
Outcomes
Primary Outcomes
Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
Time Frame: At every visit until the earliest of disease progression, death or end of study (up to 3 years)
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting through assessment of PFS in germline BRCA mutated patients was evaluated. PFS is defined as the time from first dose of olaparib to the date of progression or death from any cause. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-measurable disease, as long as progression can be documented.
Secondary Outcomes
- Time to First Subsequent Treatment or Death (TFST) in Germline BRCA Mutated Participants(At every visit until start of first subsequent anticancer treatment or death or end of study (up to 3 years))
- Time to Second Subsequent Treatment or Death (TSST) in Germline BRCA Mutated Participants(At every visit until start of second subsequent anticancer treatment or death or end of study (up to 3 years))
- Overall Survival (OS) in Germline BRCA Mutated Participants(At every visit and until death or end of study (up to 3 years))
- Time to Study Treatment Discontinuation or Death (TDT) in Germline BRCA Mutated Participants(At every visit and until discontinuation of study treatment or death or end of study (up to 3 years))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Screening (Day -28 to Day -1) until post DCO [up to 3 years])
- Time to Second Progression or Death (PFS2) in Germline BRCA Mutated Participants(At every visit until second progression or death or end of study (up to 3 years))
- Clinical Response Rate (CRR) in Germline BRCA Mutated Participants(At every visit until disease progression or death or end of study (up to 3 years))
- Duration of Clinical Response (DoCR) in Germline BRCA Mutated Participants(At every visit until disease progression or death or end of study (up to 3 years))