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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 : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tanvex BioPharma USA, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Neoplasms HER2-positive Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Biological: TX05 (trastuzumab) Biological: Herceptin® Drug: Paclitaxel Drug: Epirubicin Drug: Cyclophosphamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Biological: TX05 (trastuzumab)
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)

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

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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556358


Contacts
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Contact: Jennifer Lai, MBA 949-483-8507 jennifer.lai@tanvex.com

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Sponsors and Collaborators
Tanvex BioPharma USA, Inc.
Investigators
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Study Director: Bonnie Mills, PhD Tanvex BioPharma USA, Inc.

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Responsible Party: Tanvex BioPharma USA, Inc.
ClinicalTrials.gov Identifier: NCT03556358     History of Changes
Other Study ID Numbers: TX05-03
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tanvex BioPharma USA, Inc.:
trastuzumab
Herceptin

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Trastuzumab
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors