Overview

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.