Clinical trial
Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation…
NCT00017095 · European Organisation for Research and Treatment of Cancer - EORTC, Other · Completed
Key facts
| NCT number | NCT00017095 |
|---|---|
| Title | Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer |
| Official title | First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen |
| Lead sponsor | European Organisation for Research and Treatment of Cancer - EORTC, Other |
| Collaborators | Swedish Breast Cancer Group Swiss Cancer Institute Anglo Celtic Cooperative Oncology Group |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Breast Cancer |
| Intervention type | Biological, Drug, Genetic, Other, Procedure, Radiation |
| Interventions | filgrastim, cyclophosphamide, docetaxel, epirubicin hydrochloride, fluorouracil, microarray analysis, immunohistochemistry staining method, laboratory biomarker analysis, biopsy, conventional surgery and 2 more |
| Enrollment | 1,856 |
| Start date | Mar 1, 2001 |
| Primary completion | Nov 1, 2006 |
| First posted | Jan 27, 2003 |
| Last update posted | Oct 24, 2013 |
| Countries | Belgium, France, Netherlands, Poland, Portugal, Slovenia, Sweden, Switzerland, United Kingdom |
At a glance
- 10–99 Study sites
- No Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: