Description:
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.
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.
Active, not recruiting
Phase 3
Drug | Synonyms | Arms |
---|---|---|
TX05 (trastuzumab) | TX05 (trastuzumab) | |
Herceptin® | Herceptin® | |
Paclitaxel | Ribotax | Herceptin® |
Epirubicin | Herceptin® | |
Cyclophosphamide | Herceptin® |
Name | Type | Description | Interventions |
---|---|---|---|
TX05 (trastuzumab) | Experimental | • 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 |
|
Herceptin® | Active Comparator | • 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 |
|
Key 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 1. - Adequate bone marrow, hepatic and renal functions. - Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan. - Effective contraception as defined by protocol. Key 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). - Severe dyspnea at rest requiring oxygen therapy. - Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C. - Current pregnancy or breastfeeding. - Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Measure: | Pathologic complete response (pCR) |
Time Frame: | 3-7 weeks following last dose of study treatment |
Safety Issue: | |
Description: | 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) |
Measure: | Objective response rate (ORR) |
Time Frame: | End of Treatment (Week 24) or Early Termination Visit |
Safety Issue: | |
Description: | The sum of partial responses plus complete responses as measured per RECIST 1.1 |
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Tanvex BioPharma USA, Inc. |
February 9, 2021