CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Olaparib Oral Product +1 moredrug
Likely dose
Olaparib Oral Product 300mgfrom 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/NCT03167619
NCT03167619Phase 2Completed
CompareCT.gov

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer

Duke University·interventional·Posted May 30, 2017·Updated Sep 13, 2022

In Brief

A Phase 2 clinical trial evaluating Olaparib Oral Product and Olaparib Oral Product in combination with Durvalumab for Triple Negative Breast Cancer. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This is a randomized, international, multicenter, Phase II study designed to explore the efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC. The primary objectives are to explore olaparib or olaparib in combination with durvalumab as maintenance therapy following clinical benefit with platinum-based therapy in subjects with mTNBC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Cancer
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartOct 4, 2018
Primary CompletionJun 30, 2021
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Olaparib Oral Productdrug

olaparib 300mg twice daily

Olaparib Oral Product in combination with Durvalumabdrug

olaparib 300mg twice daily plus intravenous durvalumab every 28 days