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Observational non-interventional registry study of trastuzumab biosimilar in patients with Early Breast Cancer

Multicenter, Observational Registry to Study the Safety and Efficacy of Biosimilar Trastuzumab Intravenous Infusion in Patients with Early Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/11/016306
Enrollment
450
Registered
2018-11-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: -

Interventions

None listed

Sponsors

Biocon Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged � 18 years Patients who are willing to provide written and signed informed consent for collecting health data into the registry Patients with EBC who are eligible to receive treatment with Trastuzumab as per the approved prescribing information and clinical judgment of the treating oncologist

Exclusion criteria

Exclusion criteria: 1. Have a history of hypersensitivity to Trastuzumab or other components of the product 2. Patient with any contraindication as mentioned in approved prescribing information of Trastuzumab biosimilar 3. Any other reason (concurrent disease or condition) in the opinion of the oncologist that would make the patient unsuitable for participation in the registry

Design outcomes

Primary

MeasureTime frame
To study safety of similar biologics Trastuzumab in the treatment of patients diagnosed with HER2+ early breast cancer (EBC)Timepoint: All the adverse event data will be collected throughout study duration as assessed in routine practice by treating oncologist, maximum up to 2 years

Countries

India

Contacts

Public ContactJayanti Panda

Biocon Research Limited "Biocon"

arpitkumar.prajapati@biocon.com08028085313

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026