Trial Search Results
Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer
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 currently not accepting patients for this trial.
- Biological: Margetuximab
- 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 > or = 10.5 by HERmark® testing, are eligible for the study.
- Evidence of lack of HER2 oncogene amplification as determined by FISH testing by
- 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 > or = 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
- 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
- Major surgery or trauma within 4 weeks
- Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any
excipient contained in the margetuximab drug formulation
- Second primary malignancy that has not been in remission for more than 3 years
- History of active viral, bacterial, or systemic fungal infection requiring parenteral
treatment within 14 days
- History within 3 months of deep vein thrombosis, pulmonary embolism, or stroke
- Symptomatic or untreated central nervous system (CNS) metastatic disease. Patients
with previously treated CNS metastatic disease which has been stable for at least 56
days are eligible
- Requirement, at time of study entry, for concurrent steroids > 10 mg/day of oral
prednisone or the equivalent, except steroid inhaler, nasal spray, or ophthalmic
- Serious medical condition that would impair the ability to receive or tolerate
margetuximab; dementia or altered mental status that would preclude provision of
- Uncontrolled hypertension, heart disease including history of congestive heart
failure, history of myocardial infarction, angina pectoris requiring medication,
clinically significant valvular heart disease, high risk arrhythmias, or disease
corresponding to New York Heart Association class III or IV.
- Significant pulmonary compromise
- Have previously been exposed to MGAH22 in this or any other trial
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study