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

Recruiting

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

Sex

Female

Estimated 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 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria