A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer - DB-07

Study identifier:D967JC00001

ClinicalTrials.gov identifier:NCT04538742

EudraCT identifier:2019-004531-22

CTIS identifier:2023-505309-18-00

Recruitment Complete

Official Title

A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with other Anti-cancer Agents in Patients with HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

Medical condition

Metastatic Breast Cancer

Phase

Phase 1/2

Healthy volunteers

No

Study drug

Trastuzumab deruxtecan, Durvalumab, Paclitaxel, Pertuzumab, Tucatinib

Sex

All

Actual Enrollment

245

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 28 Dec 2020
Estimated Primary Completion Date: 31 Jan 2025
Estimated Study Completion Date: 31 Jan 2025

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited

Inclusion and exclusion criteria