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

Starting soon · Phase 3

Conditions studied: Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive

In brief

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.

Key facts

Study ID

NCT07683754

Run by

Daiichi Sankyo

People needed

200

Starts

2026-09-04

Expected to finish

2030-08-28

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Full record on ClinicalTrials.gov

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