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CTRI Number  CTRI/2023/04/051319 [Registered on: 05/04/2023] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Safety and Effectiveness assessment of Trastuzumab emtansine of Zydus Lifesciences Ltd for the treatment of early breast cancer in Indian patients. 
Scientific Title of Study   A Prospective, Multicenter, Non-Interventional, Observational, Real-World Study to Evaluate the Safety, Adherence to Therapy, and Effectiveness of a T-DM1 Antibody-Drug Conjugate Biosimilar in Indian Patients with HER2-Positive Early Breast Cancer  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
TDM1.22.01, Protocol Version Number 1.0 Dated 26-Oct-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Vipulkumar Thummar 
Designation  Manager - Medical Services Oncology 
Affiliation  Zydus Lifesciences Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad

Ahmadabad
GUJARAT
382481
India 
Phone    
Fax    
Email  Vipulkumar.Thummar@zyduslife.com  
 
Details of Contact Person
Public Query  
Name  Dr Vipulkumar Thummar 
Designation  Manager - Medical Services Oncology 
Affiliation  Zydus Lifesciences Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad

Ahmadabad
GUJARAT
382481
India 
Phone    
Fax    
Email  Vipulkumar.Thummar@zyduslife.com  
 
Source of Monetary or Material Support  
Zydus Lifesciences Limited Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar),CNr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad, 382481, Gujarat  
 
Primary Sponsor  
Name  Zydus Lifesciences Limited 
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, Sarkhej Gandhinagar Highway, Ahmedabad, 382481, Gujarat  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Gogia  All India Institute of Medical Sciences  Room No. 218, Second floor, Department of Medical Oncology, Dr. B.R.A, I.R.C.H, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029
New Delhi
DELHI 		 9013000642

ajaygogia@gmail.com 
Prof Dr Somashekhar S P  Aster CMI Hospital Bangalore  No 43/2, New Airport Road, NH 44, Sahakara Nagar, Hebbal, Bengaluru, Karnataka, 560092
Bangalore
KARNATAKA 		 9845712012

somashekhar.sp@asterhospital.com 
Dr Senthil J Rajappa  Basavatarakam Indo American Cancer Hospital and Research Institute   Road No 10, Banjara Hills, Hyderabad, 500034, Telangana, India
Hyderabad
TELANGANA 		 9849213102
40-23550015
senthiljrajappa@gmail.com 
Dr Prasad Narayanan  Cytecare Hospitals Pvt. Ltd.  Venkatala, Near Bagalur Cross, Yelahanka, Bengaluru, 560064
Bangalore
KARNATAKA 		 8022176767

prasad.narayanan@cytecare.com 
Dr Sandeep Goyle   Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Four Bungalows, Andheri - West, Mumbai, 400053, Maharashtra, India
Mumbai
MAHARASHTRA 		 9322527910
30937280
SANDEEP.GOYLE@kokilabenhospitals.com 
Dr Bhuvan Chugh  Max Super Speciality Hospital, saket (East Block - A Unit of Devki Devi Foundation)  2, Press Enclave Road, Saket, New Delhi - 110017, India
New Delhi
DELHI 		 8607773444
11-26510050
bhuvanchugh@yahoo.co.in 
Dr Ashish Joshi  Mumbai Oncocare Centre (Unit of Cellcure Cancer Centre Pvt Ltd)  2nd Floor, Majithia Apartments, God’s Gift Premises Co-Op. Society Ltd, SV Road, Irla, Vile Parle (W), Mumbai- 400056, India
Mumbai
MAHARASHTRA 		 9167009042

ashjoshi44@mocindia.co.in 
Dr Somnath Roy  Tata Medical Center  14 MAR (E-W), New Town, Rajarhat, Kolkata, 700160, West Bengal, India
Kolkata
WEST BENGAL 		 03366057870

somnath.roy1@tmckolkata.com 
Prof Dr Harsha P Panchal  The Gujarat Cancer and Research Institute  M.P. Shah Cancer Hospital, Civil Hospital Campus, Aswara, Ahmedabad-380016, Gujarat, India
Ahmadabad
GUJARAT 		 7922688000
7922680662
harsha.panchal@gcriindia.org 
Dr Mithun Shah  Zydus Cancer Centre, A unit of Zydus Hospital and Research Pvt. Ltd.  Zydus Hospital Road, Near Sola Bridge, Thaltej, S.G. Highway, Ahmedabad-380054, Gujarat, India
Ahmadabad
GUJARAT 		 9879770127
079-66190499
mithunshah@zydushospitals.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Aster Institutional Ethics Committee  Approved 
Cytecare Institutional Ethics Committee  Approved 
GCRI/GCS Ethics Committee  Approved 
INSTITUTE ETHICS COMMITTEE All INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
Institutional Ethics Committee, Basavatarakam Indo American Cancer Hospital & Research Institute  Approved 
Institutional Ethics Committee, Devki Devi Foundation  Approved 
KDAH Institutional Ethics Committee  Approved 
Mumbai Oncocare Centre Institutional Ethics Committee  Approved 
Tata Medical Center-Institutional Review Board  Approved 
Zydus Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1. Female with age ≥18 years
2. HER2-positive breast cancer: Positivity will be based on pretreatment biopsy and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH), prospectively confirmed by a hospital/laboratory before study enrollment
3. Histologically confirmed invasive breast carcinoma
4. Clinical stage at presentation: T1–4, N0–3, M0 (Note: Patients with T1a/bN0 tumors will not be eligible)
5. Completion of preoperative systemic treatment consisting of at least 4 cycles, including at least 9 weeks of trastuzumab
6. Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes
7. Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
8. Known hormone receptor status (either ER and/or PR of the primary tumor)
9. Patients who are willing to give informed consent
10. Life expectancy ≥6 months
11. Confirmed non-pregnant status for premenopausal women including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
 
 
ExclusionCriteria 
Details  1. Stage IV (metastatic) breast cancer
2. History of any prior (ipsi- or contralateral) 3. breast cancer except lobular carcinoma in situ (LCIS)
4. Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
5. Progressive disease (PD) during preoperative therapy
6. Treatment with any anti-cancer investigational drug within 28 days before commencing study treatment
7. History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ (CIS) of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above
8. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
9. Prior treatment with trastuzumab emtansine
10. For female patients, current pregnancy and/or lactation
11. Major surgical procedure unrelated to breast cancer or significant traumatic injury within approximately 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
12. History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of UJVIRA in HER2-positive EBC patients
 		 Follow up at 1 year and at 2 year
 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate adherence to UJVIRA therapy
• To evaluate the effectiveness of UJVIRA in terms of invasive disease-free survival (IDFS) in HER2-positive EBC patients
 		 Follow up at 1 year and at 2 year 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   17/04/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Non yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a Prospective, Multicenter, Non-Interventional, Real-World Study to Evaluate the Safety, Adherence to Therapy, and Effectiveness of a T-DM1 Antibody-Drug Conjugate Biosimilar (Zydus Lifesciences Ltd) patients with HER2-Positive Early Breast Cancer.


 
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