Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
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