OncRef

Clinical Trial: NCT03493854

A 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 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:2024-06-26

Study Overview

Brief Summary

This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

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 Patients With HER2-Positive Early Breast Cancer

Conditions

Early Breast Cancer

Intervention / Treatment

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

Other Study ID Numbers

  • WO40324
  • 2017-004897-32
  • 2017

Start Date (Actual)

2018-06-14

Primary Completion Date (Actual)

2019-07-04

Study Completion Date (Actual)

2023-06-02

Enrollment (Actual)

500

Study Type

Interventional

Phase

Phase 3