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

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ClinicalTrials.gov Identifier: NCT03556358
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tanvex BioPharma USA, Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE June 14, 2018
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE June 28, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Pathologic complete response (pCR) [ Time Frame: 3-7 weeks following last dose of study treatment ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03556358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
Objective response rate (ORR) [ Time Frame: End of Treatment (Week 24) or Early Termination Visit ]
The sum of partial responses plus complete responses as measured per RECIST 1.1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Breast Neoplasms
  • HER2-positive Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
Intervention  ICMJE
  • Biological: TX05 (trastuzumab)
    8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
  • Biological: Herceptin®
    8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
  • Drug: Paclitaxel
    175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
    Other Name: Ribotax
  • Drug: Epirubicin
    75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
  • Drug: Cyclophosphamide
    600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)
Study Arms  ICMJE
  • Experimental: TX05 (trastuzumab)

    • 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

    Interventions:
    • Biological: TX05 (trastuzumab)
    • Drug: Paclitaxel
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
  • Active Comparator: Herceptin®

    • 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

    Interventions:
    • Biological: Herceptin®
    • Drug: Paclitaxel
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Lai, MBA 949-483-8507 jennifer.lai@tanvex.com
Listed Location Countries  ICMJE Belarus,   Chile,   Georgia,   Hungary,   India,   Mexico,   Peru,   Philippines,   Poland,   Russian Federation,   Ukraine
Removed Location Countries Bulgaria
 
Administrative Information
NCT Number  ICMJE NCT03556358
Other Study ID Numbers  ICMJE TX05-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tanvex BioPharma USA, Inc.
Study Sponsor  ICMJE Tanvex BioPharma USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bonnie Mills, PhD Tanvex BioPharma USA, Inc.
PRS Account Tanvex BioPharma USA, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP