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.
Title
- Brief Title: Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
TX05-03
- NCT ID:
NCT03556358
Conditions
- Breast Cancer
- Breast Neoplasms
- HER2-positive Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
TX05 (trastuzumab) | | TX05 (trastuzumab) |
Herceptin® | | Herceptin® |
Paclitaxel | Ribotax | TX05 (trastuzumab) |
Epirubicin | | TX05 (trastuzumab) |
Cyclophosphamide | | TX05 (trastuzumab) |
Purpose
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.
Trial Arms
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 | - TX05 (trastuzumab)
- Paclitaxel
- Epirubicin
- Cyclophosphamide
|
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 | - Herceptin®
- Paclitaxel
- Epirubicin
- Cyclophosphamide
|
Eligibility Criteria
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 |
Primary Outcome Measures
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) |
Secondary Outcome Measures
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 |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tanvex BioPharma USA, Inc. |
Trial Keywords
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