Clinical trial · Interventional
Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.
NCT00870168CI-TRIAL-00004846completedN/AClinicalTrials.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: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast biopsy | Procedure | — | UNRESOLVED |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Changes in hormone receptor expression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * No inflammatory breast cancer * Measurable disease according to RECIST criteria * Hormone receptor status: * Estrogen receptor- and/or progesterone receptor-negative by IHC PATIENT CHARACTERISTICS: * Menopausal status not specified * WHO performance status 0-2 * Life expectancy \> 3 months * ANC \> 1.5 x 10\^9/L * Platelet count \> 100 x 10\^9/L * Liver transaminases ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 2 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No allergy to xylocaine * No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency PRIOR CONCURRENT THERAPY: * No prior first-line treatment for metastatic disease
References
Publications (0)
Data not yet available
No reference posted for this study.