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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.


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Neoplasm Metastasis

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tolerance of the patients in the both groups.

Principal Investigator

Rémy LARGILLIER, Physician

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre ANTOINE LACASSAGNE - NICE (FRANCE)

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TAXEL

NCT ID:

NCT00270491

Start Date:

December 2005

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer
  • Neoplasm Metastasis
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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