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

Tanvex BioPharma

Status and phase: Completed; Phase 3

Conditions: Stage IIIA Breast Cancer; Breast Cancer; Stage II Breast Cancer; HER2-positive Breast Cancer; Breast Neoplasms

Treatments: Drug: Cyclophosphamide; Biological: TX05 (trastuzumab); Drug: Epirubicin; Biological: Herceptin®; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03556358

TX05-03

Details and patient eligibility

About

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.

Enrollment: 809 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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809 participants in 2 patient groups

TX05 (trastuzumab)

Experimental group

Description:

• 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

Treatment:

Drug: Cyclophosphamide

Drug: Epirubicin

Drug: Paclitaxel

Biological: TX05 (trastuzumab)

Herceptin®

Active Comparator group

Description:

• 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

Treatment:

Drug: Cyclophosphamide

Drug: Epirubicin

Biological: Herceptin®

Drug: Paclitaxel