S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo

Not Recruiting

Trial ID: NCT00382018


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.

Official Title

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

Stanford Investigator(s)



   - Histologically confirmed breast cancer

      - Clinical evidence of metastatic disease (stage IV disease)

      - Newly metastatic disease OR progressive metastatic disease while on hormonal

   - 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


   - 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


   - 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


drug: chemotherapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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