Overview

A 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 Participants With HER2-Positive Early Breas

Status:
Active, not recruiting

Trial end date:
2025-12-27

Target enrollment:

Participant gender:

Summary

This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV) and trastuzumab IV formulations in Chinese participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Phase:

Phase 3

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Cyclophosphamide
Docetaxel
Doxorubicin
Hormones
Liposomal doxorubicin
Pertuzumab
Trastuzumab