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
The purpose is to determine if MGAH22 (Margetuximab) is a possible treatment for patients with breast cancer that is HER2 2+ positive with no extra copies of the HER2 gene, and how MGAH22 works to treat cancers. MGAH22 is an antibody or immunoglobulin (protein produced by immune cells) that targets cancer cells that make too much of a protein called human epidermal growth factor receptor 2, or HER2. Another way to say it is that the cells "overexpress" the protein. A test called "IHC" (Immunohistochemistry) shows whether breast cancer cells have HER2 receptors on their surface. Too much of this protein can turn a normal cell into a cancer cell and cause the cancer to grow faster. The IHC test gives a score of 0 to 3+. If the score is 0 the result is called HER2 negative. If it is 2+ or 3+ it is called HER2 positive. Another test called "FISH" (fluorescence in situ hybridization) looks at cancer cells to see if they have extra copies of the HER2 gene. This study will test whether targeting cancer cells that are HER2 2+ positive and do not have extra copies of the HER2 gene will benefit patients.
Stanford is now accepting new patients for this trial.
- biological : Margetuximab
Phase: Phase 2
Ages Eligible For Study:
- Histologically or cytologically confirmed invasive carcinoma of the breast - Treatment with at least two prior systemic therapies for advanced (unresectable locoregional or metastatic) disease - Evidence of HER2 oncoprotein expression at the 2+ level by central laboratory. Patients whose tumors exhibit 2+ staining by IHC are eligible for the study. - Patients whose tumors score 1+ by conventional IHC, are non-amplified by FISH testing, and whose tumors score >10.5 by HERmarkŪ testing, are eligible for the study. - Evidence of lack of HER2 oncogene amplification as determined by FISH testing by central laboratory - Performance Status of 0 or 1 - Life expectancy at least 6 months - Measurable disease (by RECIST 1.1) - Acceptable laboratory parameters and organ reserve - Baseline left ventricular ejection fraction >50% - Anti-cancer therapy (including conventional cytotoxic chemotherapy and/or biological therapy) and radiotherapy must be completed and any associated toxicities resolved to </= Grade 1 levels or baseline levels and at least 2 weeks must have elapsed before enrollment. Treatment with monoclonal antibodies must be completed at least 14 days before entry. Must have completed immunosuppressive medications or vaccinations before enrollment. - Patients who are ER+ and/or PR+ and who are receiving anti-hormone therapy for at least three months may continue to receive such therapy during the course of the trial - Eighteen (18) years of age or older