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

NCT03556358

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03556358

Trial Eligibility

Document

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

DrugSynonymsArms
TX05 (trastuzumab)TX05 (trastuzumab)
Herceptin®Herceptin®
PaclitaxelRibotaxTX05 (trastuzumab)
EpirubicinTX05 (trastuzumab)
CyclophosphamideTX05 (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

NameTypeDescriptionInterventions
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

  • trastuzumab
  • Herceptin

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