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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/004965
• Date of registration: 03-09-2014
• Prospective Registration: Yes
• Primary sponsor: Samsung Bioepis Co Ltd
• Public title: 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: 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
• Date of first enrolment: 27-10-2014
• Target sample size: 806
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9969
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Bosnia and Herzegovina, Bulgaria, Czech Republic, France, India, Malaysia, Mexico, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Ukraine, Viet Nam

Contacts

• Name: Dr Sudheer Balaraju
• Affiliation: Manipal Acunova Ltd

• Name: Dr Sudheer balaraju
• Affiliation: Manipal Acunova Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 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) +
Exclusion criteria: 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)

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Breast Cancer - Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting

Intervention(s)

Intervention1: 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)
Control Intervention1: 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)

Primary Outcome(s)

Pathologic complete response (pCR)Timepoint: Pathologic complete response (pCR)

Secondary Outcome(s)

To evaluate the efficacy of SB3 compared to Herceptin® by

- event-free survival

- overall survivalTimepoint: 1 Month after last dose of IP (completion of 18 cycles of therapy)

To evaluate the pharmacokinetics of SB3 compared to Herceptin®Timepoint: pre-dose of Cycle 1, 3, 5, 7 and 8

To evaluate the safety and tolerability of SB3 compared to Herceptin®Timepoint: 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)Timepoint: At pre-dose of Cycle 1, 5, 9, 14 and 1 month after the last dose of IP

To evaluate the efficacy of SB3 compared to Herceptin® by

-Total pathological complete response (tpCR) rate-

-overall clinical response rateTimepoint: Post surgery (week 24)

Secondary ID(s)

NCT02149524

SB3-G31-BC, Version 1.0 dated 08-Nov-2013

Source(s) of Monetary Support

Samsung Bioepis Co., Ltd. 107, Cheomdan-daero, Yeonsu-gu, Incheon, 406-840 Republic of Korea.

Secondary Sponsor(s)

Manipal Acunova Ltd

Ethics review

Status: Approved
Approval date: 16/04/2014
Contact:

Ethics Committee of M. S. Medical College and Hospitals

Status: Approved
Approval date: 19/04/2014
Contact:

HCG-Multispeciality Ethics Committee

Status: Approved
Approval date: 26/04/2014
Contact:

Ethics Committee, B.P Poddar Hospital and Medical Research Centre Ltd

Status: Approved
Approval date: 30/04/2014
Contact:

HCG-Central Ethics Committee, HCG Bangalore Institute of Oncology

Status: Approved
Approval date: 12/05/2014
Contact:

Institutional Ethics Committee, Apex Hospital Pvt. Ltd.

Status: Approved
Approval date: 23/05/2014
Contact:

Manipal University Ethics Committee

Status: Approved
Approval date: 28/05/2014
Contact:

Institutional Ethics Committee

Status: Approved
Approval date: 28/07/2014
Contact:

Tata Medical Center-Institutional Review Board

Status: Approved
Approval date: 30/07/2014
Contact:

Artemis Health Sciences-Institutional Review Board

Status: Approved
Approval date: 04/08/2014
Contact:

Institutional ethics committee, Tata memorial centre (IEC, TMC)

Status: Approved
Approval date: 09/09/2014
Contact:

Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre

Status: Approved
Approval date: 22/10/2014
Contact:

Institutional Ethics Committee, Fortis Memorial Research Institute

Status: Approved
Approval date: 16/12/2014
Contact:

Institutional Ethics Committee, King Georges Medical University

Status: Approved
Approval date: 27/01/2015
Contact:

Institutional Ethics Committee, Arthur Asirvatham Hospital

Status: Not Approved
Approval date:
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Institutional EC, Bhagwan Mahaveer Cancer Hospital & Research Center

Status: Not Approved
Approval date:
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Institutional Ethics Committee for Human Research Medical College

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Amrita Institute of Medical Sciences

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Govt. Medical College

Status: Not Approved
Approval date:
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Institutional Ethics Committee, JIPMER

Status: Not Approved
Approval date:
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Instututional Ethics Committee, Maulana Azad Medical College

Status: Not Approved
Approval date:
Contact:

KEM Hospital Research Centre, Ethics Committee

Results

• Date Completed: 17/01/2017