A Double-blind Randomised, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer

INTERVENTION: Product Name: CT‐P6 (trastuzumab) Product Code: CT‐P6 Pharmaceutical Form: Powder for concentrate for solution for infusion CAS Number: 180288‐69‐1 Current Sponsor code: CT‐P6 Other descriptive name: Trastuzumab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: Herceptin Product Name: Herceptin Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: trastuzumab CAS Number: 180288‐69‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ CONDITION: Metastatic breast cancer ; MedDRA version: 12.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer PRIMARY OUTCOME: Main Objective: The primary objective of this study is to demonstrate equivalent PK in terms of area; under the curve at steady state (AUCSS) between CT‐P6 and the comparator Herceptin in patients with metastatic breast cancer. Primary end point(s): Pharmacokinetic Analysis: The primary PK endpoint will be the AUCss following steady state. AUCss is defined as the AUC at steady state. Secondary Objective: The secondary objective is to obtain additional comparative PK data, as well as initial; safety and efficacy data with CT‐P6 in comparison to Herceptin in patients with; metastatic breast cancer.; The PK, PD, efficacy and safety objectives are to evaluate CtroughSS, change from baseline in serum Her‐2 shed antigen, ORR, cardiotoxicity, and immunogenicity of CT‐P6 compared to Herceptin. INCLUSION CRITERIA: 1. Written and signed informed consent, obtained prior to starting any protocol‐specific procedures. 2. Are females over 18 years of age. 3. Have pathologically confirmed, uni‐dimensionally measurable metastatic breast cancer. 4. Have a strong Her‐2 over‐expression as described by a 3+ score by immunohistochemistry (IHC) or a positive fluorescence in‐situ hybridisation (FISH) or chromogenic in‐situ hybridisation (CISH) result. 5. Have target lesions outside prior radiation fields. 6. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Have at least 4 weeks since last surgery or radiation therapy, with full recovery. Patients must have received no radiotherapy for the treatment of metastatic disease. However, patients who have received adjuvant radiotherapy as part of the treatment of early breast cancer are eligible if the last fraction of radiotherapy was administered at least 6 months prior to randomisation.