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CTRI Number  CTRI/2020/02/023210 [Registered on: 10/02/2020] Trial Registered Prospectively
Last Modified On: 10/02/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 positive Breast Cancer Who Have Completed the SB3-G31-BC study. 
Scientific Title of Study   A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT02771795  ClinicalTrials.gov 
SB3-G31-BC-E Protocol Amend. Ver 2.2 India dtd 08 Nov 2019  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  Suneela Thatte  
Designation  Head India Local Solutions Director Early Clinical Development 
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station Andheri East Mumbai 400 069

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242  
Fax    
Email  suneela.thatte@quintiles.com  
 
Details of Contact Person
Public Query  
Name  Suneela Thatte  
Designation  Head India Local Solutions Director Early Clinical Development 
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station Andheri East Mumbai 400 069

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242  
Fax    
Email  suneela.thatte@quintiles.com  
 
Source of Monetary or Material Support  
Samsung Bioepis Co., Ltd 107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987 Republic of Korea  
 
Primary Sponsor  
Name  Samsung Bioepis Co Ltd 
Address  107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987 Republic of Korea  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDS India Private Limited   Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station, Andheri East, Mumbai 400 069 
 
Countries of Recruitment     Bosnia and Herzegovina
Bulgaria
Czech Republic
France
India
Malaysia
Philippines
Poland
Republic of Korea
Romania
Russian Federation
Ukraine
Viet Nam  
Sites of Study  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Wesley M Jose  Amrita Institute of Medical Sciences  Air block Tower 3, Ground floor, Room No. 4 AIMS Ponekkara Post, Kochi, -682041
Ernakulam
KERALA 		 8547746375
4842858471
wesleymjose@aims.amrita.edu 
Dr Jebasingh Joseph  Asirvatham Specilaity Hospital  Clinical Research Department 1st floor 22 -Rajaji Street, Gandhi Nagar,Madurai-625020.
Madurai
TAMIL NADU 		 9442619775

drjebasingh.gram@gmail.com 
Dr Dhananjay Shri Krishna Kelkar  Deenanath Mangeskar Hospital and Research Centre  Lata Mangeshkar Medical Foundation’s Deenanath Mangeshkar Hospital and Research Centre, Annex Building, Surgery Department, Ground floor, Erandwane, Pune -411004
Pune
MAHARASHTRA 		 9158885177

dskelkar@gmail.com 
Dr Shashidhara H P  HealthCare Global Enterprises Ltd  HCG Towers, Tower-4, 5th Floor, No.8, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore-560027
Bangalore
KARNATAKA 		 8033466058

shashidharahp@rediffmail.com 
Dr P U Prakash Saxena  Kasturba Medical College Hospital  Department of Radiotherapy & Oncology, Ground floor, Room No.076, KMC Hospital, Attavar Mangalore- 575001
Bangalore Rural
KARNATAKA 		 9008761002
08242425092
prakashraomedispark@gmail.com 
Dr Dumbre Amol Avinash  KEM Hospital Hospital Research Centre  3rd floor, Day Care Centre, Room no. 15 Sardar Moodlar Road, Rasta Peth, Pune - 411011
Pune
MAHARASHTRA 		 9970410590

dramol2003@yahoo.com 
Dr Vijay Kumar  King George Medical University  Shatabdi Building Phase 2, Department of Surgical Oncology,3rd floor, Lucknow – 226003
Lucknow
UTTAR PRADESH 		 9935383666
0522-2258991
drvkumar2007@gmail.com 
Dr Nalini Kilara  M S Ramaiah Medical College and Hospitals  Department of Medical Oncology Ground Floor HCG Unit M S Ramaiah Nagar, MSRIT Post, Bangalore-560054.
Bangalore
KARNATAKA 		 9845089482

dranil.msr@gmail.com 
Dr Kishore Singh  Maulana Azad Medical College  Lok Nayak Hospital, 7th Floor, Room No. 701, Cancer Ward, New Delhi – 110002
New Delhi
DELHI 		 9810320341

drkishoresingh@gmail.com 
Dr Sanjoy Chatterjee  Tata Medical Centre  Radiation Oncology,Basement 14 Arterial Road (EW) Newtown Rajarhat Kolkata 700160
Kolkata
WEST BENGAL 		 9038161825

sanjoy.chatterjee@tmckolkata.com 
Dr Jyoti Bajpai  Tata Memorial Hospital  Medical Oncology 11th floor 1115 Tata Memorial Centre Dr E Borges Mar Parel (E) Mumbai 400012.
Mumbai
MAHARASHTRA 		 919920640040
91224177201
dr_jyotibajpai@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee M S Ramaiah Medical College and Hospitals M S Ramaiah Nagar, MSRIT Post, Bangalore-560054.  Submittted/Under Review 
KEM Hospital Research Centre, Ethics Committee, KEM Hospital Research Centre, Sardar Moodlar Road,  Submittted/Under Review 
HCG Central Ethics Committee, HCG- Bangalore Institute of Oncology, HCG Towers, Tower-I, 1st Floor, No.8, P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore-560027.  Submittted/Under Review 
Institutional Ethics Committee Amrita Institute of Medical Sciences & Research Centre, AIMS Ponekkara Post, Kochi - 682041  Submittted/Under Review 
Institutional Ethics Committee, Asirvatham Speciality Hospital, 22 -Rajaji Street, Gandhi Nagar, Madurai-625020.  Submittted/Under Review 
Institutional Ethics Committee, Deenanath Mangeskar Hospital and Research Centre, Lata Mangeshkar Medical Foundation’s Deenanath Mangeshkar Hospital and Research Centre,Erandwane, Pune - 411004,   Submittted/Under Review 
Institutional Ethics Committee, Manipal Hospital, No. 98, HAL Airport Road, Bangalore - 560017  Approved 
Institutional Ethics Committee, Maulana Azad Medical College, 3rd Floor, Room No. 306B, Bahadur Shah, Zafar Marg, New Delhi - 110002   Submittted/Under Review 
Institutional Ethics Committee, Office of Research Cell, Administrative Block,King George’s Medical University, Lucknow - 226003  Submittted/Under Review 
Institutional Ethics Committee-I  Submittted/Under Review 
Institutional Review Board, Tata Medical Centre, 14, Major Arterial Road (EW), Newtown, Rajarhat, Kolkata -700160.  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HER2 Positive Early or Locally Advanced Breast Cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  [Survival Only Cohort]

Subjects must meet all of the following criteria to be eligible for the study:
1. Subjects who received SB3 or Herceptin® according to the clinical trial SB3-G31-BC.
2. Subjects who provide informed consent. If prospective data collection is not possible (e.g. when the subject is deceased or lost to follow-up), a waiver of informed consent/authorization will be requested for the retrospective data collection from medical records, where applicable and in accordance with national regulations and local ethics. If ICF waiver for the deceased subject is not allowed, their next-of-kin (if applicable) will be informed accordingly and will be asked to give their consent where applicable and approved by IRB/IEC and in accordance with national regulations.
 
 
ExclusionCriteria 
Details  There are no exclusion criteria for the Survival Only Cohort. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The incidence of symptomatic CHF and asymptomatic significant LVEF decrease
CHF, defined as NYHA II, III, IV, confirmed by a cardiologist, accompanied by a
significant LVEF decrease
Significant LVEF decrease, defined as an absolute decline of at least 10% points from
baseline LVEF (LVEF at screening of the SB3-G31-BC trial) and resulting LVEF less
than 50%
 		 Entire Duration 
 
Secondary Outcome  
Outcome  TimePoints 
The incidence of cardiac death and other significant cardiac conditions
Cardiac death, defined as death definitely as a result of heart failure, myocardial
infarction, or documented arrhythmia, or as probable cardiac death
 		 -within 24 hours of a cardiac event EFS, defined as the time from the date of randomisation for the SB3-G31-BC trial to the date where an event occurs.
An eventisbreastcancer recurrence,orprogression (local,regionaldistantor contralateral)ordeathdue toanycause.
-from the date of surgery for the SB3-G31-BC trial to the date where an event occurs. An event is breast cancer recurrence (local, regional, distant, or contralateral) or death due toanycause.
 
The incidence of cardiac death and other significant cardiac conditions
o Cardiac death, defined as death definitely as a result of heart failure, myocardial infarction, or documented arrhythmia, or as probable cardiac death
 		 Timepoint 1: within 24 hours of a cardiac event
Timepoint 2: from the date of surgery for the SB3-G31-BC trial to the date where an event occurs. An event is breast cancer recurrence (local, regional, distant, or contralateral) or death due to any cause.
Timepoint 3: from the date of randomisation for the SB3-G31-BC trial to the date of death, regardless of the cause of death. Subjects who were alive at the time of analysis will be censored at the date of the last follow-up assessment. 
 
Target Sample Size   Total Sample Size="612"
Sample Size from India="89" 
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 3 
Date of First Enrollment (India)   15/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/10/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary      

This is an observational cohort study.

 

[Survival Only Cohort]: The group consists of subjects who participate in this trial among subjects who received the SB3 or Herceptin® in the SB3-G31-BC trial and were not sequentially enrolled into this SB3-G31-BC-E trial as a Cardiac Safety and Survival Cohort. Subjects who received SB3 or Herceptin® in accordance with the clinical trial SB3-G31-BC and were not sequentially enrolled to SB3-G31-BC-E trial as a Cardiac Safety and Survival Cohort will be asked to consent to participate in this study as a Survival Only Cohort. If prospective data collection is not possible (e.g. when the subject is deceased or lost to follow-up), a waiver of informed consent/authorization will be requested for the retrospective data collection from medical records, where applicable and in accordance with national regulations and local ethics. If informed consent from (ICF) waiver for the deceased subject is not allowed, their next-of-kin (if applicable) will be informed accordingly and will be asked to give their consent where applicable and approved by institutional review board (IRB)/independent ethics committee (IEC) and in accordance with national regulations. Data will be collected from medical records for up to 5 years from their last investigational product (IP; SB3 or Herceptin®) administration or death, unless they are lost for the follow-up or withdraw the informed consent. Data for the study will be collected prospectively from the date of the study informed consent signed and data before informed consent will be obtained from medical records retrospectively. If prospective data collection is not possible, data could be collected retrospectively from medical records.


 
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