A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Phase 1/2 Active not recruiting 243 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Timeline

Start: 2018-12-21
Primary completion: 2024-11-29
Completion: 2027-02-26

Outcome

Missed primary endpoint

paper ORR was 62.1% (95% confidence interval (CI): 48.4-74.5), which did not meet the protocol-specified objective of 38/57 (66.6%) responses. PMID 42259988 ↗

Publications

Schmid P, Im SA, Nowecki Z, Wysocki PJ, Jassem J, Jung KH, Lord S, Armstrong J, Stewart R, Vukovic P, Denduluri N, Park YH. First-line durvalumab in combination with trastuzumab deruxtecan in women with locally advanced unresectable or metastatic, hormone-receptor-negative, HER2-low breast cancer: multicenter, open-label, phase 1b/2 BEGONIA platform trial. Nat Cancer. 2026 Jun;7(6):983-992. doi: 10.1038/s43018-026-01181-8. Epub 2026 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capivasertib	Small molecule	—	Oral
Subject	Datopotamab deruxtecan	Monoclonal antibody	—	Intravenous
Subject	Durvalumab	Monoclonal antibody	1120 mg	Intravenous
Subject	Oleclumab	Monoclonal antibody	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous
Subject	Trastuzumab deruxtecan	Monoclonal antibody	5.4 mg/kg	Intravenous