Status:
COMPLETED
S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine whether women with metastatic breast cancer and elevated circulating tumor cells (CTCs) (≥ 5 per 7.5 mL of whole blood) after 3 weeks of first-line chemotherapy deriv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2017
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT00382018
Start Date
October 1 2006
End Date
July 11 2017
Last Update
November 6 2017
Active Locations (296)
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1
Regional Medical Center
Anniston, Alabama, United States, 36207
2
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
3
Providence Cancer Center
Anchorage, Alaska, United States, 99508
4
NEA Medical Center - Stadium Boulevard
Jonesboro, Arkansas, United States, 72401