A Single Arm Open-Label Phase 2 Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients with Relapsed or Refractory Advanced Breast Cancer Whose Tumors Express HER2 at the 2+ Level by Immunohistochemistry and Lack Evidence of HER2 Gene Amplification by FISH
Investigating the Effectiveness of an Investigational Medication for Advanced Breast Cancer
Brief description of study.
The purpose of this study is to determine if margetuximab is effective in the treatment of certain patients with relapsed or refractory advanced breast cancer.
Detailed description of study
The purpose of this study is to determine if margetuximab is effective in the treatment of certain patients with relapsed or refractory advanced breast cancer.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Cancer
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Age: 18 years - 100 years
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Gender: All
The purpose of this study is to determine if an investigational medication is effective in treating patients with relapsed or refractory advanced breast cancer. Advanced breast cancer is a stage of cancer where the cancer has spread beyond the breast to other parts of the body. Relapsed means the cancer has returned after treatment, and refractory means it does not respond to treatment.
Participants in the study will be assigned to different study arms, which means they will receive different treatments. The study will involve regular monitoring and assessments to see how well the investigational medication works and to check for any side effects.
- Who can participate: Participants must be adults diagnosed with advanced breast cancer that is either relapsed or refractory. Additional eligibility criteria include a specific age range and health status as determined by the study guidelines.
- Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Interested in the study?
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