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

Registration Number: CTRI/2018/11/016306

Lead Sponsor: Biocon Limited

Brief Summary: This is a single arm, multicenter, observational registrystudy. It will comprise of patient(s) signing an informed consent, screeningagainst eligibility criteria and enrolment into database followed by datacollection phase from the medical records of all included patients as per thehospital/ clinic practice. All patients will be treated and monitored accordingto the routine clinical practice. No additional procedures/ patient visits are plannedfor the study.

At participating center, all patients eligibleto receive treatment with Biosimilar Trastuzumab (of Biocon and Mylan) as perthe approved prescribing information for their early breast cancer will beasked to provide their consent prior to participation in this observationalregistry. Consenting patients will be screened against eligibility criteriabefore enrolling them into the registry. Baseline and follow up data will becollected from all eligible patients as per the approved prescribinginformation and hospital/ clinic practice.

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 450

Inclusion Criteria

Patient aged â‰¥ 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

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (15): Amrita Institute of Medical Sciences
🇮🇳
Kozhikode, KERALA, India
Apollo Speciality Hospital
🇮🇳
Chennai, TAMIL NADU, India
Dr. Bhimrao Ambedkar Institute of Rotary Cancer Hospital (Dr BRA IRCH)
🇮🇳
Delhi, DELHI, India
Fortis Hospital
🇮🇳
Delhi, DELHI, India
Fortis Memorial Research Institute
🇮🇳
Gurgaon, HARYANA, India
HCGÂ Abdur Razzaque Ansari Cancer Centre
🇮🇳
Ranchi, JHARKHAND, India
Health Care Global Enterprises Limited
🇮🇳
Bangalore, KARNATAKA, India
Kasturba Medical College and Hospital
🇮🇳
Udupi, KARNATAKA, India
Kokilaben Dhirubhai Ambani Hospital and Research Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Kumaran Hospitals Pvt. Ltd.
🇮🇳
Chennai, TAMIL NADU, India
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Amrita Institute of Medical Sciences
🇮🇳Kozhikode, KERALA, India
Dr Pavithran Keechilat
Principal investigator
91-9895367090
pavithrank@aims.amrita.edu