Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

March 15, 2026

Study Completion Date

November 15, 2026

Conditions
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Interventions
BIOLOGICAL

PERT-IJS plus trastuzumab, carboplatin and docetaxel

PERT-IJS is a monoclonal antibody, which has been developed by Biocon Biologics (earlier in collaboration with Viatris) as a proposed biosimilar to European Union (EU)-approved and United States (US) licensed Perjeta.

BIOLOGICAL

Perjeta plus trastuzumab, carboplatin and docetaxel

EU Perjeta (Pertuzumab) , an antineoplastic agent, is a recombinant humanized monoclonal antibody that specifically targets sub-domain 2 of the extracellular domain of Human Epidermal Growth Factor Receptor 2 (HER2), blocking heterodimerization of HER2 with other members of the receptor family, including epidermal growth factor, Human Epidermal Growth Factor Receptor 3 (HER3) and Human Epidermal Growth Factor Receptor 4 (HER4).

Trial Locations (1)

422005

RECRUITING

Chopda Medicare & Research Centre Pvt. Ltd,, Nashik

Sponsors
All Listed Sponsors
lead

Biocon Biologics UK Ltd

INDUSTRY

NCT06038539 - Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter