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CTRI Number  CTRI/2024/01/061144 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Long term Safety and efficacy of Trastuzumab in Indian female patients with HER2+ breast cancer.  
Scientific Title of Study   A Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Trastuzumab in Female Patients with HER2+ Breast Cancer. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/IV/TRUMAB/05/2022; Version 1.0; 14-May-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhadeep Sinha MD 
Designation  Senior Vice President and Head 
Affiliation  Hetero Labs Limited 
Address  Clinical Development & Medical Affairs, 2nd Floor, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone    
Fax    
Email  sd.sinha@hetero.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sreenivasa Chary S 
Designation  Senior General Manager 
Affiliation  Hetero Labs Limited 
Address  Clinical Development & Medical Affairs, 2nd Floor, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  914023704923  
Fax  914023801902  
Email  Sreenivasa.Chary@hetero.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhadeep Sinha MD 
Designation  Senior Vice President 
Affiliation  Hetero Labs Limited 
Address  Clinical Development & Medical Affairs, 2nd Floor, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  914023704923  
Fax  914023801902  
Email  sd.sinha@hetero.com  
 
Source of Monetary or Material Support  
Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018. Tel No. & Fax No.: 914023810110 
 
Primary Sponsor  
Name  Hetero Biopharma Limited 
Address  HNO.8_3_166_1,2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajeev L K  Asha Hospitals & Research Centre,   Room No. 2, First Floor, Department of Oncology, Asha Hospitals & Research Centre, No. 10, 23rd Cross, Rashtrakavi Kuvempu Nagara, BTM 2nd stage, BTM Layout, 560076. India
Bangalore
KARNATAKA 		 7022247227

drrajeevlk@gmail.com 
Dr Kalyan Kusum Mukherjee  Chittaranjan National Cancer Institute  Room No: 3, 3rd Floor, Clinical Research Room c, 37 S P Mukherjee Road, Kolkata-700026,India
Kolkata
WEST BENGAL 		 9830115905

Kkmukherjee4u@hotmail.com 
Dr K Velavan  Erode Cancer Centre  Department of Medical Oncology, Velavan Nagar, Perundurai Road, Thindal, Erode-638012, Tamil Nadu, India.
Erode
TAMIL NADU 		 9842334222

drvelavank@gmail.com 
Dr G Raja  Government Royapettah Hospital  Department of Medical Oncology, Cancer Block, Chennai-600014, Tamil Nadu, India
Chennai
TAMIL NADU 		 9841107677

grajaro78@gmail.com 
Dr Lakhsmi Priyadarshini  HCG City Cancer Centre  Department of Medical Oncology, 33-22-33, Ch Venkata krishnayya street, Suryarao pet-520002, India
Krishna
ANDHRA PRADESH 		 9966030988

priyadarshini006@gmail.com 
Dr Raj Vasantrao Nagarkar   HCG Manavata Cancer Centre  Room No: OPD 1, Ground Floor, HCG Manavata Cancer Centre, Behind Shivang Auto Mumbai Naka, 422002,India.
Nashik
MAHARASHTRA 		 9823061929

drraj@manavatacancercentre.com 
Dr Ankit Batra   Himalayan Institute of Medical Sciences, Swami Rama Himalayan Universitry  Room No: A103, Block A, Cancer Research Institute, Himalayan Institute of Medical Sciences, Swami Rama Himalayan Universitry, Swami Ram Nagar jolly Grant, 248016
Dehradun
UTTARANCHAL 		 9411712969

drankitbatra@gmail.com 
Dr Rajesh Kumar Singh  IGIMS  Department of Medical Oncology, Regional Cancer Centre, Patna, 800014 India
Sheikhpura
BIHAR 		 9939088899

drrajeshrccigimstrial@gmail.com 
Dr Patil Tushar Vishvasrao  Integrated Cancer Treatment and Research Centr  Room No: OPD 3, Ground Floor, Integrated Cancer Treatment and Research Centre, Vishwashanti Dham, Kesnand Road, Wagholi, Pune- 412207, India
Pune
MAHARASHTRA 		 9552522556

tussipats@hotmail.com 
Dr Aloke Ghosh Dastidar  IPGME&R, SSKM Hospital  Room No. 15, Ground Floor, IPGME&R, SSKM Hospital, 244, Acharya Jagadish Chandra Bose Road,700020, India.
Kolkata
WEST BENGAL 		 9831118494

alokeghoshdastidar@yahoo.com 
Dr Rohan Bhise  KLES Dr. Prabhakar Kore Hospital & Medical Research Centre  Department of Medical Oncology, Nehru Nagar, Belagavi- 590010, India.
Belgaum
KARNATAKA 		 7975558921

rohanbhise30@gmail.com 
Dr Ashish Kaushal   Kusum Dhirajlal Hospital (KD Hospital)  Department of Medical Oncology, Vaishnodevi Circle, S. G. Highway, Ahmedabad-382421, India
Ahmadabad
GUJARAT 		 9978297842

drashish4@yahoo.co.in 
DrPRadhika  MNJ Hospital  Department of Medical Oncology, Red Hills, Hyderabad – 500004, Telangana State, India
Hyderabad
TELANGANA 		 9848792682

radhika.parimkayala@gmail.com 
Dr Pritam Kalaskar  Mumbai Oncocare Centre  Department of Medical Oncology, 1st Floor, Blue Nile Building, Almeda Rd, next to pinnacle hospital, Charai, Naka-400601,India
Thane
MAHARASHTRA 		 8828000863

drpritamkalaskar@mocindia.co.in 
Dr Srikrishna Mandal  NRS Medical College & Hospital  Room No: 205, 1st Floor, Department of Radiotherapy, NRS Medical College & Hospital, 138 A J C Bose Road, 700014
Kolkata
WEST BENGAL 		 9830648931

drskmandal1959@gmail.com 
Dr Budhi Singh Yadav  Post Graduate Institute of Medical Education and Research  Department of Radiotherapy, Nehru Extension, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh-160012,India
Chandigarh
CHANDIGARH 		 7087008103

drbudhi@gmail.com 
Dr Lokesh K N  Radhakrishna Multispeciality Hospital & IVF Center  Department of Medical Oncology, Sunrise tower, JP Road, Girinagar - 560085, India
Bangalore
KARNATAKA 		 8971609070

drlokeshkn.rmh@gmail.com 
Dr Syed Nisar Ahmad   Sher-I-kashmir Institute of Medical Sciences  Room No. 304, 3rd Floor, Department of Medical Oncologgy, Sher-I-kashmir Institute of Medical Sciences, Soura, India
Srinagar
JAMMU & KASHMIR 		 9469664186

syednisar76@yahoo.co.in  
Dr Gerald Anand Raja  SRM Medical College Hospital & Research Centre  Department of Medical Oncology, Kattankulathur- 603203, Chengalpattu, India
Kancheepuram
TAMIL NADU 		 7010107751

gerraja@gmail.com 
Dr Kaushal Kalra  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Medical Oncology, New Delhi-110029
New Delhi
DELHI 		 9968663394

kaushalkalra@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Institutional Ethics Committee MNJ Institute of Oncology & Regional Cancer  Approved 
Ethics Committee NRS Medical College and Hospital  Approved 
Ethics Committee, Swami Rama Himalayan University  Approved 
IEC - SKIMS Sher-i-kashmir Institute of Medical Sciences  Approved 
Institutional ethics Committe KLE University  Submittted/Under Review 
Institutional Ethics Committee SRM Medical College Hospital & Research Centre  Approved 
Institutional Ethics Committee BGS Global Institute of Medical Science  Approved 
Institutional Ethics Committee Vardhman Mahavir Medical College and Safdarjung Hospital  Submittted/Under Review 
Institutional Ethics Committee Erode Cancer Centre  Approved 
Institutional Ethics Committee Ashraya Medinova Private limited   Approved 
Institutional Ethics Committee HCG Curie City Cancer Centre  Approved 
Institutional Ethics Committee KD Hospital   Submittted/Under Review 
Institutional Ethics Committee Kilpauk Medical College  Approved 
Institutional Ethics Committee Mumbai Oncocare Centre  Submittted/Under Review 
Institutional Ethics Committee, IGIMS  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research  Submittted/Under Review 
Institutional Ethics Committee, CNCI  Submittted/Under Review 
IPGME&R Research Oversight Committee, IPGME&R, Kolkata  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Supreme Independent Ethics Committee, Ingenious Healthcare 1856, Bhekarai Nagar, Opposite to IBM Company, Fursungi, Fursungi Haveli Pune Maharashtra - 412308 India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hetero Trastuzumab  The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1. Female patients of age 18 and above
2. Patients willing to give written, signed, and dated informed consent to participate in the study
3. Patients with breast cancer with evidence of HER2-overexpression by immunohistochemistry (IHC) or HER2 gene amplification by fluorescence in situ hybridization (FISH) or positive chromogenic in-situ hybridization (CISH) result.
4. Patients with any other approved indication(s) as per the prescribing information at the discretion of principal investigator 
 
ExclusionCriteria 
Details  1. Patients with history of hypersensitivity to the trastuzumab or to any of the excipients, or to murine proteins or any other chemotherapeutic agent planned along with Trastuzumab
2. Male patients with breast cancer
3. Patients treated with Trastuzumab as (neo)adjuvant within 12 months or for metastatic breast cancer (Hetero-Trastuzumab use for MBC is allowed)
4. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest
5. Patients with a history or evidence of cardiovascular diseases including congestive heart failure (CHF) of Grade IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia, unstable angina pectoris, myocardial infarction
6. Patients who are pregnant or a nursing mother.
7. Patients received treatment with investigational drug in the last 90 days 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Significant clinical signs and symptoms developed during the treatment period.
2. Significant changes observed in laboratory parameters during treatment period. 		 52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Anti-Trastuzumab antibodies (ATA) against Hetero– Trastuzumab.
2. Objective Response Rate or progression, whichever is earlier.
3. Progression free survival (PFS) over study duration. 		 6 months and 12 months or progression, whichever is earlier. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   It is a Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Trastuzumab in Female Patients with HER2+ Breast Cancer. Hetero-Trastuzumab is available in 150 mg or 440 mg vials. Reconstitution with appropriate diluent (SWFI), yields a solution containing 21 mg/mL trastuzumab, at a pH of approximately 6. Safety is the primary objective, immunogenicity and efficacy are the secondary objectives of the study. Significant clinical signs and symptoms developed, changes observed in laboratory parameters, and Incidence of AEs leading to dose discontinuation of the medication are the part of primary outcome. Assessment of Anti-Trastuzumab antibodies, Objective of Response Rate (ORR), Progression Free Survival (PFS) after 6 months and 12 months of treatment, are the secondary outcomes. 
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