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

Phase 2 Completed 45 enrolled Duke University AstraZeneca · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2018-10-04
Primary completion: 2021-06-30
Completion: 2022-06-30

Outcome

Met primary endpoint

paper both significantly longer than the historical control (P = 0.0023 and P < 0.0001, respectively). PMID 38236575 ↗

Publications

Tan TJ, Sammons S, Im YH, She L, Mundy K, Bigelow R, Traina TA, Anders C, Yeong J, Renzulli E, Kim SB, Dent R. Phase II DORA Study of Olaparib with or without Durvalumab as a Chemotherapy-Free Maintenance Strategy in Platinum-Pretreated Advanced Triple-Negative Breast Cancer. Clin Cancer Res. 2024 Apr 1;30(7):1240-1247. doi: 10.1158/1078-0432.CCR-23-2513.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Olaparib	Small molecule	300 mg	Oral