A study to compare the test test drug used with chemotherapy and trastuzumab with chemotherapy in patients with advanced HER2+ breast cancer who have received prior treatment with other medications.

What we are studying

This study will test whether patients with metastatic or locally-advanced HER2-positive breast cancer that has worsened following two standard treatments or lines of therapy will benefit from treatment with standard chemotherapy plus margetuximab compared to standard chemotherapy plus trastuzumab (also called Herceptin®). Your participation in this study will likely last at least 10 weeks (4 weeks to see if you qualify, plus two 3-week cycles of study drug) and can continue until your cancer progresses, you want to stop, or your study doctor believes that you should stop for medical reasons. The first re-evaluation of your cancer status will take place about 6 weeks after your first dose of study drug. During those first 6 weeks, you will have about 5 office visits with the study doctor or other staff. If your cancer does not worsen, you may have additional cycles if you continue to tolerate the combination of chemotherapy plus study drug. It is estimated that, overall, this study will last approximately 36 months. Margetuximab will be given at a dose of 15 milligrams per kilogram (15 mg/kg) of body weight. Trastuzumab will be given at a starting dose of 8 milligrams per kilogram (8 mg/kg) of body weight for the first 3-week cycle, then 6 milligrams per kilogram (6 mg/kg) of body weight for all other cycles. This is the standard dose of trastuzumab to use in this setting. Both margetuximab and trastuzumab will be given by intravenous (IV) infusion. In other words, the study drugs will enter your body through a plastic tube that is placed into a vein. Chemotherapy will be given according to the schedule of the chosen agent following local practice.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Life expectancy ? 12 weeks
  • Can not have a known
  • Untreated brain metastasis
  • Cannot have a history of uncontrolled seizures
  • No prior allogeneic bone marrow
  • Stem-Cell
  • Or solid organ transplantation
  • No active hepatitis B or hepatitis C infection
  • No Prior participation in a margetuximab clinical study
  • Active or history of alcohol or other substance abuse within 1 year

What is involved

  • Echocardiogram
  • MUGA scan
  • ECG
  • Medical history
  • Physical exam
  • Blood draw
  • Bone scan
  • MRI
  • CT
  • Physical exam
  • Pregnancy test
  • Questionnaires
  • Drug administration

Compensation

travel expenses, overnight lodging

Contact Information

Study Coordinator
Stacey Lewis
Email
[email protected]
Phone
-6927
Principal Investigator
Susan Melin, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.