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Breast Cancer

The Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Purpose

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 which is working to control the tumor.

In this study, patients will get either surgery plus radiation or continue with the best medical treatment advised by their doctor.

Eligibility

Eligibility criteria include the following:

  • Must have an intact primary (not recurrent) invasive carcinoma of the breast proven by breast biopsy
  • Must not have synchronous contralateral breast cancer
  • Registration into the study must take place within 32 weeks but no less than 16 weeks of systemic therapy
  • Must have 16 weeks of optimal systemic therapy
  • Must have at least one distant organ system involved with metastatic disease
  • Must not have disease progression since starting systemic therapy
  • Must be judged to be a candidate for complete resection followed by radiation therapy
  • Local disease within the affected breast must be free of symptoms
  • Can be male or female
  • Must be at least 18 years of age
  • Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
  • Must not be pregnant or nursing
  • Projected survival must be greater than six months

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment

ARM S:

  • Optimal systemic therapy as determined by the treating physician

ARM A:

  • Continue systemic therapy as directed by the treating physician
  • Provide local therapy only for palliation of symptoms (radiation, surgery, or a combination)

ARM B:

  • Early local therapy
    • Surgery within 10 weeks after completion of 32 weeks of systemic therapy (this can be breast conserving therapy or total mastectomy)
    • Systemic therapy may resume after recovery from surgery as directed by the treating physician
    • Radiation should be given after surgery for all breast conserving therapy patients and when appropriate for total mastectomy patients

Patients will be followed on this study for at least five years.