Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Paclitaxel

Criteria

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