E2108 A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
This research is being done because even after the most aggressive anticancer treatment for patients with metastatic (stage IV) breast cancer, tumors that shrink or disappear tend to recur. The current standard of treatment is chemical or hormonal therapy. According to present knowledge, breast surgery and radiation would not help to control the disease when metastases are present in other places. However, recent evidence suggests that performing breast surgery and radiation in addition to chemical or hormonal therapy may help stage IV patients survive longer. This study will help decide which treatment is better.
You may be able to participate if you: - Have a cancerous tumor on one breast, but not both breasts; - Your breast tumor is new cancer, not one that has recurred after treatment in the past; - Your breast cancer has spread to at least one place outside the breast; - Had biopsies confirming that the tumor on your breast and another elsewhere in your body are cancerous; - Have a radiology report confirming your disease before you undergo therapy in part 1; These are only the main requirements. Your doctor will perform a more detailed review of your eligibility.
In part 1 of the study, you will receive a chemical or hormonal therapy to which your doctor and you have agreed. This treatment will last for 4 months. Then if the metastases in other parts of your body have not grown, you will be eligible to continue into part 2 of the study. If your metastases worsen (grow), you will not be eligible to continue with part 2 of the study and your doctor will give you the best agreed-on therapy for your condition. If you are eligible to continue into part 2, you will be randomly assigned, by 50:50 chance, to a treatment group. Neither you nor your doctor will know the group to which you will be assigned. If you are in the standard-therapy group, you will receive the same, uninterrupted anticancer treatment as in part 1, or a new treatment at your doctorâ??s discretion. You will receive surgery and/or radiation treatment for your breast only if the tumor starts to grow and you have pain or your breast skin breaks down. If you are in the experimental group, your anticancer treatment will be interrupted and you will undergo either breast-conserving surgery or a mastectomy (surgery for the lymph nodes may also be required), followed by radiation therapy, before resuming your anticancer treatment from part 1. Regardless of whether or not you are randomized, you will be followed as part of this study for 5 years.
12/10/2013 04:02 AM