A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- TX05 (trastuzumab)
- Conditions
- Breast Cancer
- Sponsor
- Tanvex BioPharma USA, Inc.
- Enrollment
- 809
- Locations
- 146
- Primary Endpoint
- Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
- •Available tumor tissue for central review of HER2 status.
- •Planned surgical resection of breast tumor.
- •Planned neoadjuvant chemotherapy.
- •Documentation of HER2 gene amplification or overexpression.
- •Ipsilateral, measurable tumor longest diameter \> 2 cm.
- •Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
- •ECOG performance status of 0 or
- •Adequate bone marrow, hepatic and renal functions.
- •Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
Exclusion Criteria
- •Investigational therapy within 2 months of first dose of study drug.
- •Bilateral breast cancer.
- •Inflammatory breast cancer
- •Metastases.
- •Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
- •Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
- •Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
- •Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
- •Pre-existing clinically significant Grade 2 peripheral neuropathy.
- •Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
Arms & Interventions
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: TX05 (trastuzumab)
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Paclitaxel
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Epirubicin
TX05 (trastuzumab)
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Cyclophosphamide
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Herceptin®
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Paclitaxel
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Epirubicin
Herceptin®
• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles Followed by: • IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles
Intervention: Cyclophosphamide
Outcomes
Primary Outcomes
Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
Time Frame: 3-7 weeks following last dose of study treatment
Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).
Secondary Outcomes
- Objective Response Rate (ORR)(End of Treatment (Week 24) or Early Termination Visit)