Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
Condition: Breast Cancer; Breast Neoplasms; HER2-positive Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: TX05 (trastuzumab); Herceptin®; Paclitaxel; Epirubicin; Cyclophosphamide
Intervention description: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8); 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8); 175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8); 75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4); 600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Trastuzumab; Epirubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 809.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trastuzumab; Herceptin

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.
    

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.