Who is sponsoring NCT05283837?

NCT05283837 is sponsored by Zydus Lifesciences Limited.

What drugs are being tested in NCT05283837?

Interventions in NCT05283837: Pertuzumab (ZRC-3277), Pertuzumab (Perjeta®).

What condition does NCT05283837 study?

NCT05283837 studies Metastatic Breast Cancer.

Is NCT05283837 still recruiting?

NCT05283837 is currently completed. Last updated 18 July 2024.

Last reviewed 2024-07-18 · How we verify

NCT05283837

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 18 July 2024

What this trial tests

Phase 3 trial testing Pertuzumab (ZRC-3277) in Metastatic Breast Cancer in 268 participants. Completed in 6 September 2023.

Timeline

26 September 2022

Primary endpoint
6 September 2023

6 September 2023

Quick facts

Lead sponsor	Zydus Lifesciences Limited
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	268
Start date	26 September 2022
Primary completion	6 September 2023
Estimated completion	6 September 2023
Sites	1 location across India

Drugs / interventions tested

Pertuzumab (ZRC-3277) — full drug profile →
Pertuzumab (Perjeta®) — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Zydus Lifesciences Limited — full company profile →

Who can join

Adults 18 to 65, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115

Verify or expand the search:

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other Zydus Lifesciences Limited trials

Trials by the same sponsor.

NCT05911828 — A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combina · Phase 1 · recruiting
NCT06398808 — A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately · Phase 2 · completed
NCT05981040 — Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Scl · Phase 2 · completed
NCT05872269 — A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities · Phase 4 · unknown
NCT05515367 — A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05283837 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zydus Lifesciences Limited
Last refreshed: 18 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05283837.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing