Clinical Trial ECOG 2108
- A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
- Principal Investigator
- Seema Khan
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 2108
- The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in the breast to the standard approach of continued treatment with the medication.
- Participants in this study have a cancerous tumor in their breast that has also spread beyond to one or more other places in the body. When cancer spreads to another part of the body, this is called “metastatic disease”. The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication. When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain, which happens only in some patients. For most people, the tumor in the breast is controlled with medicine and does not cause problems. We do not know if local treatment (surgery and/or radiation) used early in the course of treatment of the breast cancer will help patients with metastatic breast cancer live longer or not.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have at least one site of distant metastatic disease.
- Participants must have an intact primary invasive tumor of the breast.
- Description of Treatment
- Participants in this study will initially receive the medication for the breast cancer that the doctor recommends. This may include chemotherapy or anti-hormone pills, and will last for about four months. At the end of four months, participants will be randomly assigned to one of two groups. Depending on which group assigned, participants will either continue with the treatment that is working (the standard of care) or will have surgery (and possibly radiation) for the tumor in the breast (the new approach).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 31-Aug-15 08:15 AM
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