CTRI/2018/11/016306 [Registered on: 09/11/2018] Trial Registered Prospectively
Last Modified On:
10/02/2022
Post Graduate Thesis
Type of Trial
Observational
Type of Study
Observational non-interventional registry study
Study Design
Other
Public Title of Study
Observational non-interventional registry study of trastuzumab biosimilar in patients with Early Breast Cancer
Scientific Title of Study
Multicenter, Observational Registry to Study the Safety and Efficacy of Biosimilar Trastuzumab Intravenous Infusion in Patients with Early Breast Cancer
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BM200-EBC-04-I-02
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Subramanian Loganathan
Designation
Chief Scientific Manager
Affiliation
Biocon Research Limited "Biocon"
Address
Biocon House,Semicon Park, Electronic City Phase II, KARNATAKA,India Bangalore KARNATAKA 560100 India
Phone
08028085305
Fax
Email
subramanian.l101@biocon.com
Details of Contact Person Scientific Query
Name
Dr Arpitkumar Kaushikkumar Prajapati
Designation
Manager
Affiliation
Biocon Research Limited "Biocon"
Address
Biocon House,Semicon Park, Electronic City Phase II,
Bangalore KARNATAKA 560100 India
Phone
08028085313
Fax
Email
arpitkumar.prajapati@biocon.com
Details of Contact Person Public Query
Name
Jayanti Panda
Designation
Senior Scientific Manager
Affiliation
Biocon Research Limited "Biocon"
Address
Biocon House,Semicon Park, Electronic City Phase II
Bangalore KARNATAKA 560100 India
Phone
8028085304
Fax
Email
Jayanti.Panda@biocon.com
Source of Monetary or Material Support
Biocon Limited,
20th KM, Hosur Road, Electronic City, Bengaluru, Karnataka 560100
Primary Sponsor
Name
Biocon Limited
Address
20th KM Hosur Road
Electronic City,
Bangalore, India - 560 100
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 15
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Pavithran Keechilat
Amrita Institute of Medical Sciences
Room No. 2, Department of Medial Oncology, AIMS Ponekkara, P O. Cochin, Kerala - 682041, India Kozhikode KERALA
C Block, First floor, Department of Medial Oncology, No. 320, Padma Complex, Anna Salai, Chennai, Tamilnadu - 600035, India Chennai TAMIL NADU
91-9841700827
drmaraja@gmail.com
Dr Subhash Gupta
Dr. Bhimrao Ambedkar Institute of Rotary Cancer Hospital (Dr BRA IRCH)
Room no. 215, First floor, Department of Radiotherapy and Oncology, All India Institute Of Medical sciences (AIIMS), Ansari Nagar, New Delhi - 110029, India New Delhi DELHI
91-9868398341
drsubhashgupta72@gmail.com
Dr Mohit Agrawal
Fortis Hospital
Ground Floor, Department of Oncology, Shalimar Bagh, Delhi - 110088, India New Delhi DELHI
91-9717888797
mohit10k@gmail.com
Dr Vinod Raina
Fortis Memorial Research Institute
Room No. 5, Lower ground floor, Department of Medial Oncology, Sector-44, Opp. Huda City Centre Metro Station, Gurgaon, Haryana - 122002, India
Gurgaon HARYANA
First Floor, Department of Medical Oncology, H B Road, IRBA, Ranchi, Jharkhand - 835217, India Ranchi JHARKHAND
91-7761848530
ksoncologist@gmail.com
Dr Radheshyam Naik
Health Care Global Enterprises Limited
First Floor, Department of Medical Oncology, HCG Towers, Tower 1, 1st Floor, No. 8, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore, Karnataka - 560027, India Bangalore KARNATAKA
Ground Floor, Department of Oncology, No. 214, E. V. R. Periyar Salai, Poonamallee High Road, Kilpauk, Chennai, Tamilnadu - 600010, India Chennai TAMIL NADU
91-9840410194
crrt.onco@gmail.com
Dr Poonam Patil
Manipal Hospital
1st Floor, Department of Oncology,98, HAL Airport Road, Bangalore, Karnataka - 560017, India Bangalore KARNATAKA
91-9945687185
poonam.patil@manipalhospitals.com
Dr Amit Jetani
Shree Giriraj Multispeciality Hospital
Ground floor, Department of Oncology, 27, Navjyot Park Corner, 150 feet Ring Road, Rajkot, Gujarat - 360005, India Rajkot GUJARAT
91-9825713758
dramitjetani@ymail.com
Dr Ghanashyam Biswas
Sparsh Hospitals and Critical Care Private Limited
Ground floor, Department of Medial Oncology, Plot No - A/407, Saheed Nagar, Bhubaneswar, Odisha - 751007, India Khordha ORISSA
91-9937500878 91-674-2545860 drgbiswas@gmail.com
Dr Joydeep Ghosh
Tata Medical Center
Room No. 121, First floor, Department of Medical Oncology, 14, Major Arterial Road (East-West), Newtown, Rajahat, Kolkata - 700161, India Kolkata WEST BENGAL
91-9167814217
dr.joydeep.ghosh@gmail.com
Dr G Vamshi Krishna Reddy
Yashoda Hospital
OP - 5, Room No. 2, Ground floor, Deaprtment of Medical Oncology, Nalgonda "X" Roads, Malakpet, Hyderabad, Telangana - 500036, India Hyderabad TELANGANA
91-9000600555
drvkreddy18@gmail.com
Details of Ethics Committee
No of Ethics Committees= 15
Name of Committee
Approval Status
Ethics Committee of Manipal Hospitals, Bangalore
Submittted/Under Review
HCG - Central Ethics Committee For HCG Curie Abdur Razzaque Ansari Cancer Institute, Ranchi
lnstitutionaI Ethics Committee - Yashoda Academy of Medical Education and Research (IEC - YAMER)
Submittted/Under Review
lnstitutionaI Ethics Committee Amrita Institute of Medical Sciences,Cochin, Kerala
Submittted/Under Review
lnstitutionaI Ethics Committee- Fortis Memorial Research Institute, Gurgaon, Haryana
Submittted/Under Review
lnstitutionaI Ethics Committee- Kokilaben Dhirubhai Ambani Hospital and Research Centre, Mumbai, Maharashtra
Submittted/Under Review
lnstitutionaI Review Board - Tata Medical Center
Submittted/Under Review
Shree Giriraj Hospital Research Ethics Committee, Rajkot
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="450" Sample Size from India="450" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a single arm, multicenter, observational registry
study. It will comprise of patient(s) signing an informed consent, screening
against eligibility criteria and enrolment into database followed by data
collection phase from the medical records of all included patients as per the
hospital/ clinic practice. All patients will be treated and monitored according
to the routine clinical practice. No additional procedures/ patient visits are planned
for the study.
At participating center, all patients eligible
to receive treatment with Biosimilar Trastuzumab (of Biocon and Mylan) as per
the approved prescribing information for their early breast cancer will be
asked to provide their consent prior to participation in this observational
registry. Consenting patients will be screened against eligibility criteria
before enrolling them into the registry. Baseline and follow up data will be
collected from all eligible patients as per the approved prescribing
information and hospital/ clinic practice.