CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 256 enrolled
Drug / intervention
Olaparibdrug
Likely dose
Olaparib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03286842
NCT03286842Phase 3Completed
CompareCT.gov

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.

AstraZeneca·interventional·Posted Sep 19, 2017·Updated Jan 17, 2023

In Brief

A Phase 3 clinical trial evaluating Olaparib for HER2-ve Metastatic Breast Cancer and 2 related conditions. Completed, enrolled 256 participants across 123 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2-ve Metastatic Breast Cancer, Germline BRCA1/2 Mutations, Somatic BRCA1/2 Mutations
CountriesBulgaria, Canada, France, Germany, Hungary, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 19, 2017
Enrollment StartJan 17, 2018
Primary CompletionOct 8, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.8 years ago

Interventions

Olaparibdrug

Patients will be administered olaparib orally, twice daily at 300 mg. Two (2) 150 mg olaparib tablets should be taken at the same time each morning and evening of every day, approximately 12 hours apart.