S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: chemotherapy
Intervention description: No administration details available
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 624.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Measuring blood levels
      of tumor cells may help in learning how well chemotherapy works to kill metastatic breast
      cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are
      high while receiving chemotherapy, it is not yet known whether it is more effective to change
      chemotherapy regimens at that time or wait until disease progression.

      PURPOSE: This randomized phase III trial is studying treatment decision making based on blood
      levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Clinical evidence of metastatic disease (stage IV disease)

               -  Newly metastatic disease OR progressive metastatic disease while on hormonal
                  therapy

          -  Meets 1 of the following criteria:

               -  Measurable disease

               -  Bone-only disease* NOTE: *Patients with nonmeasurable disease that does not
                  include bone are not eligible

          -  HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ
             hybridization (FISH) assay

               -  HER-2 positivity is defined as IHC 3+ or FISH+

               -  If IHC is indeterminate (2+), FISH must be performed to classify disease

          -  Planning to undergo first-line chemotherapy for metastatic disease

          -  Patients with brain metastases must have stable disease for > 90 days after completion
             of prior radiotherapy to the brain

          -  No leptomeningeal disease

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Female

          -  Menopausal status not specified

          -  Zubrod performance status 0-2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or stage I or II cancer currently in complete remission

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or
             bevacizumab for metastatic disease allowed

               -  Any number of exogenous hormonal therapies for metastatic disease and/or as
                  adjuvant therapy allowed

          -  At least 1 year since prior adjuvant chemotherapy

          -  At least 2 weeks since prior minor surgery and recovered

          -  At least 4 weeks since prior major surgery and recovered

          -  No prior chemotherapy for metastatic disease

          -  Concurrent hormonal therapy and/or bisphosphonate therapy allowed

          -  Concurrent trastuzumab and/or bevacizumab allowed