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A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

NCT03013504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2024-11-06

No results posted yet for this study

Summary

In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

Conditions

  • HER2 Positive Breast Cancer

Interventions

DRUG

HD201

Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles.

DRUG

Herceptin

Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles.

DRUG

Docetaxel

75mg/m2 via i.v. infusion during cycles 1 to 4.

DRUG

Epirubicin

75 mg/m2 via i.v. infusion during cycles 5-8.

DRUG

Cyclophosphamide

500 mg/m2 via i.v. infusion during cycles 5-8.

Sponsors & Collaborators

  • Prestige Biopharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-04-19
Completion
2022-01-13

Countries

  • Belarus
  • Bulgaria
  • Estonia
  • France
  • Georgia
  • Hungary
  • Italy
  • Malaysia
  • Poland
  • Russia
  • Spain
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT03013504 on ClinicalTrials.gov