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.
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