NCT05283837

A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)

A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel Study to Evaluate the Efficacy and Safety of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) With Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Patients With HER2 Positive Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus Trastuzumab and Docetaxel treatment in previously untreated patients with HER2 positive MBC.

Detailed description

Breast cancer is the second most common cancer worldwide and the fifth cause of death from cancer overall (522,000 deaths) and it is the most frequent cause of cancer death in women in less developed regions.In developed countries between 6 and 10 % of women will have metastatic disease when diagnosed with breast cancer ; in developing countries this percentage can reach 60 %. Depending on initial stage, tumor biology, and type of treatment scheme received, between 30 and 50 % of women with early breast cancer will relapse. Pertuzumab targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3, and HER4. As a result, Pertuzumab inhibits ligandinitiated intracellular signaling through two major signal pathways, mitogenactivated protein (MAP) kinase, and phosphoinositide 3-kinase (PI3K). Inhibition of these signaling pathways can result in cell growth arrest and apoptosis, respectively. In addition, Pertuzumab mediates antibody-dependent cellmediated cytotoxicity (ADCC). Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular 286 dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein 287 (HER2). Pertuzumab inhibits ligandinitiated intracellular signaling through two 299 major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase 300 (PI3K). Hence we have planned this study which is a Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel study to Evaluate the Efficacy and Safety of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pertuzumab (ZRC-3277)	Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles.
BIOLOGICAL	Pertuzumab (Perjeta®)	Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles.

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2022-03-17
• Last updated: 2024-07-18

Locations

1 site across 1 country: India