Clinical trial · Observational
Safety of Xeloda in Solid Tumours
NCT02479217CI-TRIAL-00026035completedClinicalTrials.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 primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.
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, Colon Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Xeloda | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Adjuvant therapy
- description
- Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer
- interventionNames
- Drug: Xeloda
- label
- Combination Therapy
- description
- Patients prescribed Xeloda with docetaxel for metastatic breast cancer after failure to anthacyclines were observed until disease progression
- interventionNames
- Drug: Docetaxel
- Drug: Xeloda
- label
- Monotherapy
- description
- Patients prescribed Xeloda per registered indicatilons were observed until disease progression or 8 cycles for adjuvant colon cancer
- interventionNames
- Drug: Xeloda
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Metastatic Breast Cancer: * women \>=18 years of age * Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. * Previous therapy should have included an anthracycline. * Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. * Female patients with histopathologically proven metastatic breast cancer * Adequate bone marrow, liver, renal and cardiac functions Colon Cancer: * Patients \>18 years of age * Patients with histologicaly confirmed colon cancer * Patients with potential curative tumor resection within 8 weeks before enrolment in the study * Patients previously not treated with chemiotherapy Exclusion Criteria: Metastatic Breast Cancer: * Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda) * Patients with contraindications for any of study drugs as listed in approved SmPC Colon Cancer: * Patients previously treated with chemiotherapy * Patients with contraindications for study drug as listed in approved SmPC
References
Publications (0)
Data not yet available
No reference posted for this study.