Clinical trial · Interventional
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
- 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)
Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen. Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen
Conditions
Conditions (2)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven breast adenocarcinoma * Evaluable or measurable metastases * HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH * Previously treated with anthracyclines and taxanes * Age \> = 18 y * No more than two previous chemotherapy regimens for metastases * No nervous central system involvement * Hormonal therapy must have been stopped two weeks before enrollment * Adequate biologic function * Performance status OMS \< = 2 * Signed informed consent Exclusion Criteria: * History of other malignancies, except basocellular cancer, in situ cervix carcinoma * Gastro intestinal disease that might affect absorption of capecitabine * Cardiac failure or angina pectoris uncontrolled * Hypersensitivity for capecitabine, fluorouracil, or one of their excipient * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Concomitant anticancer therapy (included hormonotherapy) * Concomitant radiotherapy * Treatment with sorivudine and analogs * Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required. * Inclusion in an experimental protocol within 30 days
References
Publications (0)
Data not yet available