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Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

This study has been completed.
Information provided by:
First received: December 26, 2005
Last updated: February 24, 2011
Last verified: February 2011
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.

Condition Intervention Phase
Breast Cancer
Neoplasm Metastasis
Drug: Paclitaxel
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • tolerance of the patients in the both groups.

Secondary Outcome Measures:
  • - Response rates and duration of response.
  • - Haematological and non-haematological toxicities.
  • - Progression free survival.
  • - Overall survival.

Estimated Enrollment: 130
Study Start Date: December 2005
Study Completion Date: October 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00270491

Paris, France, 75004
Sponsors and Collaborators
Principal Investigator: Rémy LARGILLIER, Physician Centre ANTOINE LACASSAGNE - NICE (FRANCE)
  More Information Identifier: NCT00270491     History of Changes
Other Study ID Numbers: TAXEL
Study First Received: December 26, 2005
Last Updated: February 24, 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites processed this record on April 25, 2017