Trial Profile

A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Patients With HER2-Positive Early Breast Cancer

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 17 Mar 2025

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At a glance

Drugs Pertuzumab/trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin; Pertuzumab; Trastuzumab
Indications Advanced breast cancer; Early breast cancer; HER2 positive breast cancer; Inflammatory breast cancer; Male breast cancer
Focus Pharmacokinetics; Registrational
Sponsors Roche

13 Mar 2025 Planned End Date changed from 11 Nov 2025 to 8 Feb 2026.
10 Mar 2022 Planned End Date changed from 27 Dec 2025 to 11 Nov 2025.
06 Jul 2021 Planned primary completion date changed from 30 Apr 2022 to 1 Feb 2022.

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