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PARP Inhibitor

To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.

Münster, Germany
Phase 3
Waitlist Available
Led By Karen Gelmon, MD, FRCPC
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at every visit until death or end of study for up to 3 years.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

See full description
Eligible Conditions
  • Breast Cancer
  • BRCA Mutations

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at every visit until death or end of study for up to 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at every visit until death or end of study for up to 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
Secondary study objectives
Clinical Response Rate (CRR) in Germline BRCA Mutated Participants
Duration of Clinical Response (DoCR) in Germline BRCA Mutated Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+5 more
Other study objectives
CRR in somatic BRCA mutated patients
Disease control rate in the subset of germline or somatic BRCA mutated patients with brain metastases at baseline
DoCR in somatic BRCA mutated patients
+6 more

Side effects data

From 2022 Phase 4 trial • 202 Patients • NCT04330040
100%
Asthenia
100%
Retinal vascular occlusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Both Ovarian Cancer and Breast Cancer
Ovarian Cancer
Breast Cancer

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OlaparibExperimental Treatment1 Intervention
Olaparib 150mg tablets administered orally twice daily continuously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~2310

Find a Location

Closest Location:Research Site· Toronto, Canada· 318 miles

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,485 Previous Clinical Trials
290,541,651 Total Patients Enrolled
1 Trials studying BRCA Mutations
450 Patients Enrolled for BRCA Mutations
Karen Gelmon, MD, FRCPCPrincipal InvestigatorBritishColumbiaCancerAgency, 600W.10th Ave,Vancouver,Canada.
~31 spots leftby Mar 2026
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