Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

• Status: Completed
• Trial end date: 2021-02-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanvex BioPharma USA, Inc.
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Paclitaxel; Trastuzumab

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.