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:N/A

CTIS identifier:N/A

Recruiting

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, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Durvalumab, Durvalumab, Paclitaxel, Paclitaxel, Pertuzumab, Tucatinib, Tucatinib

Sex

All

Actual enrollment

450

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 28 Dec 2020
Estimated Primary Completion Date: 30 Dec 2024
Estimated Study Completion Date: 30 Dec 2025

Study design

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

Verification:

Verified 01 Jan 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited

Inclusion and exclusion criteria