Clinical trial · Interventional
Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.
A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.
NCT00270491CI-TRIAL-00004471completedPhase 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)
Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasm Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tolerance of the patients in the both groups.
Secondary outcomes (4)
- measure
- - Response rates and duration of response.
- measure
- - Haematological and non-haematological toxicities.
- measure
- - Progression free survival.
- measure
- - Overall survival.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Femal patient aged \> 18 years * Histologically proven breast adenocarcinoma * HER2 negative receptors * previously received first or second line chemotherapy for metastatic disease * previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy * presence of one or several evaluable metastatic lesion(s) * presence of at least one target lesion not previously irradiated * previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study) * ECOG Performance status \< 2 * adequate biological values * patient who has clearly given her consent by signing on informed consent form prior to participation Exclusion Criteria: * patient previously treated with paclitaxel or capecitabine for metastatic breast cancer * patient with only local metastatic disease (with the exception of axillary lymph nodes) * active symptomatic brain metastasis * patient with an history of significant cardiovascular impairment (congestive heart failure\> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia) * peripheric neuropathy grade ≥ 2 * history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin) * patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study * patient with a known allergy to one or several of the study compounds * patients who may not be regularly available due to geographical, social or family reasons * history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product * deficiencies of the upper intestinal tract, malabsorption syndrome * patient who is pregnant, breast-feeding or using inadequate contraception
References
Publications (0)
Data not yet available
No reference posted for this study.