Clinical trial · Interventional
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
NCT00214864CI-TRIAL-00006261completedPhase 2ClinicalTrials.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)
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel, capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with histopathologically proven metastatic breast cancer. * Patients 18-75 years old * Performance status: Karnofsky \> 70% * Patients must have measurable disease. Patients with only blastic bone lesions are ineligible. * Adequate bone marrow, liver, renal and cardiac functions defined as: * Ability to understand the study and give informed consent. * Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible. Exclusion Criteria: * Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for \> 3 months. * Patients who have received any anti-cancer investigational agent in the month prior to inclusion. * Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda). * Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome. * Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.
References
Publications (0)
Data not yet available
No reference posted for this study.