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MGAH22 in Breast Cancer


Title Breast Cancer - Determining Effect of MGAH22 in Breast Cancer Patients
Therapeutic Area Breast Cancer
Principal Investigator John Erban, MD
Min Age 18 Years
Gender Female
Contact Madeline Arthur
617-636-7651

Overview

To determine if MGAH22 has sufficient activity in the population of breast cancer participants whose tumors exhibit 2+ HER2 oncoprotein expression and lacks HER2 gene amplification.

Study Details

Inclusion Criteria

  • Participants must have invasive carcinoma of the breast
  • Adequate organ reserve including cardiovascular, pulmonary, renal, hepatic functioning sufficient to undergo therapy.

Exclusion Criteria

  • Participants who have had major surgery or trauma within four weeks before enrollment
  • History within three months of enrollment of deep vein thrombosis, pulmonary embolism, or stroke.
  • Any serious underlying medical condition that would impair the ability to receive or tolerate the planned treatment

Study Requirements

Screening tests must be done within 4 weeks before participants receive the first dose of MGAH22. The tests will check their medical history and overall health and the tests will measure their disease with a CT scan.The test drug MGAH22 will be given once a week for 3 weeks on Days 1, 8, and 15 of each cycle. The study drug will be given through a thin plastic tube that is placed into the arm vein.Participants will have blood draws, CT scans and other exams as per protocol.