OncRef

Clinical Trial: NCT05415215

A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-02-10

Study Overview

Brief Summary

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

Official Title

A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

Conditions

Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer

Intervention / Treatment

  • Drug: Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
  • Drug: Pertuzumab IV
  • Drug: Trastuzumab IV
  • Drug: Trastuzumab Emtansine
  • Drug: Investigator's Choice of Chemotherapy
  • Procedure: Surgery
  • Radiation: Radiotherapy

Other Study ID Numbers

  • MO43110
  • 2021-002346-33
  • 2023-506380-33-00
  • 2023

Start Date (Actual)

2022-07-05

Primary Completion Date (Actual)

2024-11-20

Study Completion Date (Actual)

2025-11-07

Enrollment (Actual)

346

Study Type

Interventional

Phase

Phase 3