Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00270491
Recruitment Status : Completed
First Posted : December 28, 2005
Last Update Posted : February 25, 2011
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Neoplasm Metastasis Drug: Paclitaxel Drug: Capecitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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

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

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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00270491

Paris, France, 75004
Sponsors and Collaborators
Principal Investigator: Rémy LARGILLIER, Physician Centre ANTOINE LACASSAGNE - NICE (FRANCE) Identifier: NCT00270491     History of Changes
Other Study ID Numbers: TAXEL
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 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