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

NCT03556358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 809

Last updated 2022-01-14

Study results available
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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.

Conditions

Interventions

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)

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)

Sponsors & Collaborators

  • Tanvex BioPharma USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Bonnie Mills, PhD · Tanvex BioPharma USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2020-11-27
Completion
2021-02-04
FDA Drug
Yes

Countries

  • Belarus
  • Chile
  • Georgia
  • Hungary
  • India
  • Mexico
  • Peru
  • Philippines
  • Russia
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03556358 on ClinicalTrials.gov