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
- Health Condition 1: null- 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
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
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) +
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic complete response (pCR)Timepoint: Pathologic complete response (pCR)
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of SB3 compared to Herceptin® by <br/ ><br>- event-free survival <br/ ><br>- overall survivalTimepoint: 1 Month after last dose of IP (completion of 18 cycles of therapy);To evaluate the efficacy of SB3 compared to Herceptin® by <br/ ><br>-Total pathological complete response (tpCR) rate- <br/ ><br>-overall clinical response rateTimepoint: Post surgery (week 24);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 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