A study of novel anti-cancer agents in patients with metastatic triple negative breast cancer - BEGONIA

Study identifier:D933LC00001

ClinicalTrials.gov identifier:NCT03742102

EudraCT identifier:2018-000764-29

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab (MEDI4736) + paclitaxel and durvalumab (MEDI4736) in combination with novel oncology therapies with or without paclitaxel for first-line metastatic triple negative breast cancer

Medical condition

Triple Negative Breast Neoplasms

Phase

Phase 1/2

Healthy volunteers

No

Study drug

Durvalumab, Durvalumab, Durvalumab, Durvalumab, Durvalumab, Durvalumab, Capivasertib, Oleclumab, Paclitaxel, Paclitaxel, Paclitaxel, Trastuzumab deruxtecan, Datopotamab deruxtecan, Datopotamab deruxtecan

Sex

Female

Actual enrollment

240

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 21 Dec 2018
Estimated Primary Completion Date: 15 Aug 2024
Estimated Study Completion Date: 15 Aug 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria