Clinical Trials Directory

Trials / Completed

CompletedNCT02492711

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

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
624 (actual)
Sponsor
MacroGenics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BIOLOGICALMargetuximab15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
BIOLOGICALTrastuzumab8 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
DRUGPhysician'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

Timeline

Start date
2015-08-24
Primary completion
2021-08-11
Completion
2022-06-14
First posted
2015-07-09
Last updated
2025-03-17
Results posted
2022-11-23

Locations

167 sites across 18 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Puerto Rico, South Korea, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT02492711. Inclusion in this directory is not an endorsement.