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

HER2-positive Early Breast Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Breast Neoplasms
HER2-positive Early Breast Cancer

Clinical Trial Details

NCT number	NCT04024462
Study type	Interventional
Source	Hoffmann-La Roche
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	February 5, 2020
Completion date	November 11, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05113251` - Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer	Phase 3
Recruiting	`NCT04750122` - Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients	Phase 1/Phase 2
Completed	`NCT03989037` - A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer	Phase 3
Not yet recruiting	`NCT05704829` - NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer	Phase 2
Completed	`NCT03674112` - A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer	Phase 2