Clinical Trial DRUG CP-MGAH22-04
- A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
- Principal Investigator
- William Gradishar
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CP-MGAH22-04
- The main purpose of this study is to evaluate how well margetuximab and chemotherapy works compared to trastuzumab and chemotherapy in patients with advanced HER2+ breast cancer.
- Participants in this study will have HER2+ breast cancer, which means that their HER2 gene is turned on too much. When the HER2 gene is turned on too much, cells grow faster than normal, causing a tumor. Participants on this study will receive standard chemotherapy in addition to either trastuzumab or margetuximab. Trastuzumab is an approved drug by the Food & Drug Administration (FDA). It is approved for treating breast and other cancers, although not approved in this setting. Margetuximab is not approved by the FDA, meaning it is “investigational”. Both trastuzumab and margetuximab are antibodies (proteins used by the immune system). They both attach to the HER2 protein and may help the immune system find and kill cancer cells. In this clinical trial, margetuximab is being studied to determine if it may do a better job of showing your immune system where the cancer cells are.
Some of the eligibility criteria include:
- Patients should be at least 18 years old.
- Patients may be male or female.
- Patients should have metastatic or locally-advanced HER2+ breast cancer.
- Patients must have received prior treatment for this cancer.
- Description of Treatment
- All participants will receive standard chemotherapy chosen by their doctor. Options for standard chemotherapy include capecitabine, eribulin, gemcitabine, and vinorelbine. These drugs will be given according to standard practice. Capecitabine is a pill that is taken by mouth. The other three drugs are given directly into a vein. In addition to standard chemotherapy, participants will receive either trastuzumab or margetuximab. These are both given directly into a vein. Participants can continue their treatment until their cancer gets worse, they want to stop, or their study doctor believes that they should stop for medical reasons.
- Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
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last updated: 24-Jun-17 08:58 PM
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