Clinical trial · Observational
Blood Levels of Tumor Cells in Predicting Response in Patients Receiving First-Line Chemotherapy for Stage IV Breast Cancer
Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer
NCT00898014CI-TRIAL-00004816completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Correlation of circulating tumor cells (CTC) with overall survival
- measure
- Correlation of CTC with progression-free survival
Secondary outcomes (2)
- measure
- Correlation of circulating tumor cells with tumor markers, clinical response, and radiological response
- measure
- Change in HER-2 status in patients receiving trastuzumab (Herceptin®)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage IV breast cancer * Measurable or evaluable disease * Scheduled to receive first-line chemotherapy with or without trastuzumab (Herceptin®), depending on HER-2 status * Histologic block available for confirming pathologic diagnosis and measuring HER-2 status via FISH PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * No other cancer in the past 5 years except for basal cell skin cancer or epithelial in situ cancer of the cervix * No geographic, social, or psychiatric reasons that would make treatment impossible PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.