A Phase III Study of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Protocol
11-190
Full Title
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer (ECOG 2108)
Phase
III
Purpose

Surgery and radiation therapy are commonly used to treat early-stage breast cancer, but their value for the treatment of metastatic breast cancer (cancer which has spread to other parts of the body) is not well known. Women with metastatic breast cancer typically receive chemotherapy, hormonal therapy, or other medication, and surgery is used only if the breast tumor becomes too large or causes symptoms.

In this study, researchers want to assess the value of treating the intact primary breast tumor with “local” therapy (surgery and radiation) in addition to standard chemotherapy and other medications used for the treatment of metastatic breast cancer. Following an initial course of standard chemotherapy, hormonal therapy, or other medication, patients who have a good response to treatment will be randomly assigned to receive surgery and radiation therapy for the breast tumor, or to continue with medical treatment (chemotherapy, hormonal therapy, and/or other medication). Patients in the medication group who are not responding well to treatment will have the option of receiving surgery and/or radiation for the breast tumor if their doctors feel they need it.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic breast cancer with an intact primary tumor in one breast.
  • Patients may enter the study either with no prior treatment or within the first 16 weeks of treatment.

For more information and to inquire about eligibility for this study, please contact Dr. Tari A King at 646-888-5432.

Disease(s)
Breast Cancer
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