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Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

NCT02162667 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2022-08-03

Study results available
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Summary

This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.

Conditions

  • HER2-positive Carcinoma of Breast

Interventions

DRUG

Trastuzumab

Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.

Sponsors & Collaborators

  • Nippon Kayaku Co., Ltd.

    collaborator INDUSTRY

  • Celltrion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-05-26
Completion
2018-10-31

Countries

  • Argentina
  • Belarus
  • Bosnia and Herzegovina
  • Chile
  • France
  • Georgia
  • Hungary
  • India
  • Italy
  • Japan
  • Latvia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Africa
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02162667 on ClinicalTrials.gov