OncRef

Clinical Trial: NCT04024462

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 Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-02-20

Study Overview

Brief 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.

Official Title

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

Conditions

HER2-positive Early Breast Cancer

Intervention / Treatment

  • Drug: Pertuzumab IV
  • Drug: Trastuzumab IV
  • Drug: Pertuzumab and Trastuzumab FDC SC
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
  • Drug: Docetaxel
  • Procedure: Surgery
  • Radiation: Post-Operative Radiotherapy
  • Drug: Hormone Therapy

Other Study ID Numbers

  • YO41137

Start Date (Actual)

2020-02-05

Primary Completion Date (Actual)

2021-12-13

Study Completion Date (Actual)

2026-01-19

Enrollment (Actual)

200

Study Type

Interventional

Phase

Phase 3