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

NCT05283837 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2024-07-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Dr Deven Parmar, MD · Zydus Lifesciences Ltd (formerly Known as Cadila Healthcare Ltd)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2023-09-06
Completion
2023-09-06

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05283837 on ClinicalTrials.gov