Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer - DB-06

Study identifier:D9670C00001

ClinicalTrials.gov identifier:NCT04494425

EudraCT identifier:2019-004493-26

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) versus Investigator’s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

Medical condition

advanced or metastatic breast cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Trastuzumab deruxtecan, Capecitabine, Paclitaxel, Nab-Paclitaxel

Sex

All

Actual Enrollment

866

Study type

Interventional

Age

18 Years - 105 Years

Date

Study Start Date: 24 Jul 2020
Primary Completion Date: 18 Mar 2024
Estimated Study Completion Date: 19 Jun 2026

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Inclusion and exclusion criteria