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Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

NCT02492711 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2025-03-17

Study results available
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Summary

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.

A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

Conditions

  • HER-2 Positive Breast Cancer
  • Metastatic Neoplasm

Interventions

BIOLOGICAL

Margetuximab

15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,

BIOLOGICAL

Trastuzumab

8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion on day 1 of each 21 day cycle

DRUG

Physician's choice of chemotherapy.

Capecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2021-08-11
Completion
2022-06-14

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • United Kingdom

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 NCT02492711 on ClinicalTrials.gov