A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer - DB-08

Study identifier:D967JC00002

ClinicalTrials.gov identifier:NCT04556773

EudraCT identifier:2020-002797-27

CTIS identifier:2023-505690-33-00

Recruitment Complete

Official Title

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Medical condition

Metastatic Breast Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

Trastuzumab deruxtecan, Durvalumab, Paclitaxel, Capivasertib, Anastrozole, Fulvestrant, Capecitabine

Sex

All

Actual Enrollment

138

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 17 Dec 2020
Primary Completion Date: 16 Aug 2023
Estimated Study Completion Date: 28 Nov 2025

Study design

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

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Co., Ltd., Daiichi Sankyo Company, Limited

Inclusion and exclusion criteria