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CP-MGAH22-04


Title 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
Therapeutic Area Breast Cancer
Principal Investigator John Erban, MD
Min Age 18 Years
Gender Female
Contact Madeline Arthur
617-636-7651
More Information https://clinicaltrials.gov/ct2/show/NCT02492711

Overview

The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

Study Details

Inclusion Criteria

  • Patients with HER2+ breast cancer
  • Prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine

Exclusion Criteria

  • Patients with known, untreated brain metastasis
  • Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment

Study Requirements

Patients will be screened for up to 28 days to see if they are eligible for the study. If eligible, patients will be enrolled and treated with study drug for 3 week (21 day) cycles. The first re-evaluation of the cancer status will take place about 6 weeks after the subject’s first dose of study drug. During those first 6 weeks, subjects will have about 5 office visits with the study doctor or other staff. If the cancer does not worsen, subjects may have additional cycles if they continue to tolerate the combination of chemotherapy plus study drug. Subjects may also have CT or MRI scans, bone scans, ECG, blood tests, physical exams, ECHO or MUGA, study questionnaires and other procedures as required by the protocol. Patients will remain on study treatment until there is reason to discontinue. Once off treatment, patients will have a follow-up visit and then be followed every 3 months.