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.
- Conditions
- Breast Cancer - Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting
- Registration Number
- CTRI/2014/09/004965
- Lead Sponsor
- Samsung Bioepis Co Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 806
- Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer.
- 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) +.
- 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic complete response (pCR) Pathologic complete response (pCR)
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of SB3 compared to Herceptin® by -Total pathological complete response (tpCR) rate- 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® pre-dose of Cycle 1, 3, 5, 7 and 8 To evaluate the safety and tolerability of SB3 compared to Herceptin® Throughout the conduct of the trial
Trial Locations
- Locations (21)
Ahsirvatham Specialty Hospital
🇮🇳Madurai, TAMIL NADU, India
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Apex Hospital Pvt Ltd
🇮🇳Jaipur, RAJASTHAN, India
Artemis Health Institute
🇮🇳Gurgaon, HARYANA, India
B.P.Poddar Hospital & Medical Research Ltd
🇮🇳Kolkata, WEST BENGAL, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
🇮🇳Jaipur, RAJASTHAN, India
Calcutta Medical College & Hospitals
🇮🇳Kolkata, WEST BENGAL, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Fortis Memorial Research Institute
🇮🇳Gurgaon, HARYANA, India
Government Medical College & Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Scroll for more (11 remaining)Ahsirvatham Specialty Hospital🇮🇳Madurai, TAMIL NADU, IndiaDr J JebasinghPrincipal investigator919442619775jjebasingh@gmail.com