Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
Condition: Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore
      elimination of this source of metastasizing cells by early local therapy may be of benefit.

      PURPOSE: This randomized phase III trial is studying early surgery to see how well it works
      compared to standard palliative therapy in treating patients with stage IV breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate whether early local therapy of intact primary disease in patients with Stage
           IV breast cancer whose disease does not progress during initial optimal systemic
           therapy, will result in prolonged survival, compared to patients who receive local
           therapy for palliation only.

      Secondary

        -  To compare the time to uncontrolled chest wall disease between patients who receive
           early local therapy versus patients who receive palliative local therapy.

        -  To determine whether there is a difference in health-related quality-of-life (HRQOL)
           between patients who receive early local therapy versus patients who receive palliative
           local therapy.

        -  To determine whether the absolute value of circulating tumor cells (CTC) burden at 6
           months following randomization (time +6) will be lower in the palliative therapy arm
           than in early local therapy arm, and whether this value is inversely related to survival
           (lower CTC, longer survival).

      Exploratory

        -  To collect tumor and blood specimens for future exploration of the biological
           interactions between the primary tumor and metastatic lesions and the effect of primary
           tumor resection.

      OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor
      and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-,
      chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of
      involved organ systems with distant disease (regional nodes in the axillary, supraclavicular,
      and internal mammary locations are not considered distant sites) (1 vs > 1). Patients are
      randomized to 1 of 2 treatment arms in 1:1 ratio.

        -  Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such
           as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar
           situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination
           of both.

        -  Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total
           mastectomy according to patient and treating physician preference. Surgery is to occur
           no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical
           margins must be achieved with re-excision or mastectomy for patients undergoing BCT.
           After completion of BCT, patients undergo radiotherapy once a day, 5 days per week.
           Patients who had mastectomy undergo radiotherapy at the discretion of treating
           physician.

      Patients may undergo blood and tumor tissue sample collection for circulating tumor cells
      (CTC) burden and future studies.

      Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index
      (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life
      questionnaires at baseline and periodically during study.

      After completion of study therapy, patients are followed up periodically for 5 years.
    

Intervention name(s): palliative surgery; therapeutic conventional surgery; palliative radiation therapy; radiation therapy
Intervention type(s): Procedure; Procedure; Radiation; Radiation
Intervention description(s): Undergo standard palliative surgery; Undergo early surgery; Undergo standard palliative radiotherapy; Undergo radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; local therapy