Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
- Conditions
- Stage II Breast CancerStage IIIA Breast CancerBreast CancerBreast NeoplasmsHER2-positive Breast Cancer
- Interventions
- Biological: Herceptin®Biological: TX05 (trastuzumab)
- Registration Number
- NCT03556358
- Lead Sponsor
- Tanvex BioPharma USA, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 809
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TX05 (trastuzumab) Paclitaxel • 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 TX05 (trastuzumab) Epirubicin • 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® 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 Herceptin® Epirubicin • 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 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 TX05 (trastuzumab) Cyclophosphamide • 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® Cyclophosphamide • 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 Herceptin® Paclitaxel • 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
- Primary Outcome Measures
Name Time Method Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR) 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 Outcome Measures
Name Time Method Objective Response Rate (ORR) End of Treatment (Week 24) or Early Termination Visit Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.
Trial Locations
- Locations (146)
Tanvex Investigational Site 1008
🇧🇾Lesnoy, Minsk Region, Belarus
Tanvex Investigational Site 1007
🇧🇾Babruysk, Mogilev Region, Belarus
Tanvex Investigational Site 1003
🇧🇾Gomel, Belarus
Tanvex Investigational Site 1006
🇧🇾Grodno, Belarus
Tanvex Investigational Site 1002
🇧🇾Minsk, Belarus
Tanvex Investigational Site 1005
🇧🇾Mogilev, Belarus
Tanvex Investigational Site 1001
🇧🇾Vitebsk, Belarus
Tanvex Investigational Site 4001
🇨🇱Temuco, Chile
Tanvex Investigational Site 4002
🇨🇱Viña Del Mar, Chile
Tanvex Investigational Site 5006
🇬🇪Batumi, Georgia
Scroll for more (136 remaining)Tanvex Investigational Site 1008🇧🇾Lesnoy, Minsk Region, Belarus