CTRI/2014/09/004965 [Registered on: 03/09/2014] Trial Registered Prospectively
Last Modified On:
15/11/2017
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to compare the efficacy and safety of SB3 (proposed trastuzumab biosimilar) and Herceptin® in women with HER2 Positive Early or Locally Advanced Breast Cancer.
Scientific Title of Study
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NCT02149524
ClinicalTrials.gov
SB3-G31-BC, Version 1.0 dated 08-Nov-2013
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Mobius Tower, SJR-i Park,
EPIP, Whitefield,
Bangalore 560066, Karnataka, India
Countries of Recruitment
Bosnia and Herzegovina Bulgaria Czech Republic France India Malaysia Mexico Philippines Poland Republic of Korea Romania Russian Federation Ukraine Viet Nam
88, College Street,Kolkata-700073 Kolkata WEST BENGAL
919831097315
drsarkarsmay@rediffmail.com
Dr Dhananjay Shrikrishna Kelkar
Deenanath Mangeshkar Hospital and Research Centre
Medical Director, 6th floor, B wing, Deenanath Mangeshkar Hospital and Research Centre
Off Karve Road, Erandawane, Pune 411004, Maharashtra. Pune MAHARASHTRA
02025420104
mdoffice@dmhospital.org
Dr Vinod Raina
Fortis Memorial Research Institute
Department of radiation oncology, Sector 44 (Opposite HUDA City Metro Station), Gurgaon 122 002, Haryana, India Gurgaon HARYANA
Department of Medical oncology, Tower 1, 3rd floor, HCG Towers, No.8, P. Kalinga Rao Road, Sampangiram Nagar, Bangalore – 560027, Karnataka, India Bangalore KARNATAKA
08040206000
shashidharahp@rediffmail.com
Dr Ashish Mangilal Kaushal
HCG Cancer Centre
Department of Medical Oncology, ground floor, Sola- Science City Road, Near Sola Bridge, S.G Highway, Ahmedabad- 380060, Gujarat, India Ahmadabad GUJARAT
07940410141
drashish4@yahoo.co.in
Dr Smita Kayal
Jawaharlal Institute of Postgraduate Medical Education and Research
Department of Medical oncology, Super specialty block, 3rd floor Regional Cancer Centre, Dhanvantri Nagar, Gorimedu, Puducherry-605 006, INDIA Pondicherry PONDICHERRY
04132272390
kayalsmita@gmail.com
Dr Krishna Prasad
Kasturba Medical College Hospital
Department of Medical Oncology, Attavar, Mangalore- 575001, Karnataka, India Dakshina Kannada KARNATAKA
08242425092
drkrishnaprasad@hotmail.com
Dr Amol Dumbre
KEM Hospital Research Centre
Sardar Moodliar Road, Rasta Peth, Pune-411011 Pune MAHARASHTRA
919970410590
dramol2003@yahoo.com
Dr Vijay Kumar
King George Medical University
Department of Surgical Oncology, King George Medical University, Chowk, Lucknow– 226003, Uttar Pradesh, INDIA Lucknow UTTAR PRADESH
05222257452
drvkumar2007@rediffmail.com
Dr Pedapenki Ravi Mohan
King George Hospital
Consultant Medical Oncologist, Department of Radiotherapy, Andhra Medical College, Visakhapatnam-530002, Andhra Pradesh Visakhapatnam ANDHRA PRADESH
08912712755
oncoravi@rediffmail.com
Dr Vinayak Maka
M S Ramaiah Medical College and Hospitals
Department of Medical oncology ,Ground floor, New B E L Road, MSRIT Post,
Bangalore-560054
Karnataka, India Bangalore KARNATAKA
08022182912
drvinayakvmaka@gmail.com
Dr Kishore Singh
Maulana Azad Medical College
Loknayak Hospital,
New Delhi – 110002 New Delhi DELHI
919968604364
drkishoresingh@gmail.com
Dr Sanjay Chattopadhyay
Tata Medical Centre
Department of Radiation oncology, Ground floor,14 Major Arterial Road (EW),New Town, Rajarhat, Kolkata – 700 156, West Bengal. Kolkata WEST BENGAL
03366057101
sanjoy.chatterjee@tmckolkata.com
Dr Jyoti Bajpai
Tata Memorial Hospital
Room No. 1115, 11th Floor, Homi Bhabha Block, Dr. E. Borges Marg, Parel, Mumbai - 400012. Mumbai MAHARASHTRA
Breast Cancer - Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Herceptin
Trastuzumab -
For Neo-Adjuvant Therapy: 8 mg/kg (loading dose), then 6 mg/kg (maintenance dose) every 3 weeks for 8 cycles (24 weeks)
For Adjuvant Therapy: 8 mg/kg (loading dose), then 6 mg/kg (maintenance dose) every 3 weeks for 10 cycles (30 weeks)
Intervention
SB3
Trastuzumab biosimilar-
For Neo-Adjuvant Therapy: 8 mg/kg (loading dose), then 6 mg/kg (maintenance dose) every 3 weeks for 8 cycles (24 weeks)
For Adjuvant Therapy: 8 mg/kg (loading dose), then 6 mg/kg (maintenance dose) every 3 weeks for 10 cycles (30 weeks)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Female
Details
Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer.
a. tumour size greater than or equal to 2 cm
b. histologically confirmed primary invasive carcinoma of the breast
c. HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH) +
ExclusionCriteria
Details
1. Metastatic (stage IV) or bilateral or multifocal/multicentric breast cancer
2. History of any prior invasive breast carcinoma, except for subjects with a past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) treated with surgery only
3. Past or current history of malignant neoplasms within 5 years prior to Randomisation, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin (malignant neoplasms occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)
4. Previous history of radiation therapy, immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy)
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Pathologic complete response (pCR)
Pathologic complete response (pCR)
Secondary Outcome
Outcome
TimePoints
To evaluate the efficacy of SB3 compared to Herceptin® by
- event-free survival
- overall survival
1 Month after last dose of IP (completion of 18 cycles of therapy)
To evaluate the efficacy of SB3 compared to Herceptin® by
-Total pathological complete response (tpCR) rate-
-overall clinical response rate
Post surgery (week 24)
To evaluate the safety and tolerability of SB3 compared to Herceptin®
Throughout the conduct of the trial
To evaluate the immunogenicity of SB3 compared to Herceptin® (Incidence of anti-drug antibodies (ADAs) and neutralising antibodies (Nabs)
At pre-dose of Cycle 1, 5, 9, 14 and 1 month after the last dose of IP
To evaluate the pharmacokinetics of SB3 compared to Herceptin®
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a randomized phase III, double-blind, parallel group, multicentre study to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB3 and Herceptin® in women with HER2 positive EBC or LABC in neoadjuvant setting. Subjects will be randomised in a 1:1 ratio to either receive SB3 or Herceptin® in neoadjuvant setting for 8 cycles concurrently with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil/epirubicin/ cyclophosphamide). Subjects will then undergo surgery. After surgery, subjects will receive further 10 cycles of adjuvant SB3 or Herceptin® as per randomisation to complete one year of therapy. The primary endpoint is the pCR rate of the primary breast tumour and the secondary endpoints are tpCR, Overall clinical response rate, EFS and OS.