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T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd

Study acronym: DB-Guide
StatusNot Yet Recruiting
PhasePhase 3
Started2026-09-04
View on ClinicalTrials.gov ↗

Amendment history

2026-07-22
Study Status, Eligibility v1
Eligibility criteria-92 characters
[...] I or T-DM1) to diagnosis of advanced or metastatic disease. Participant who has received one prior line of endocrine therapy in the metastatic setting. ECOG PS of 0 or 1 assessed no more than 3 days prior to init [...]
2026-07-01
Original filing
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.
Trial Details
NCT Number NCT07683754
Lead Sponsor Daiichi Sankyo
Collaborators: AstraZeneca
Conditions Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
Enrollment 200 participants
Start Date 2026-09-04
Primary Completion 2030-07-04 (estimated)
Study Completion 2030-08-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-23