Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Neoplasm Metastasis

Treatments

Drug: Capecitabine

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00270491

TAXEL

Details and patient eligibility

About

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.

Full description

The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.

Enrollment

130 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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