Trial Profile

A Phase 3, Randomized, Multi-center, Open-Label Study of DB-1303 Versus Investigator's Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-Low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 05 Mar 2025

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At a glance

Drugs BNT 323 (Primary) ; Capecitabine; Paclitaxel
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Acronyms DYNASTY-Breast02
Sponsors Duality Biologics

28 Feb 2025 Planned End Date changed from 1 May 2028 to 1 Jul 2028.
28 Feb 2025 Planned primary completion date changed from 1 Dec 2025 to 1 May 2026.
02 Jan 2025 Trial design( will recruit 532 patients at 230 centers ) discussed in an abstract published at 49th European Society for Medical Oncology Congress

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