Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

This study has been completed.
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00270491
First received: December 26, 2005
Last updated: February 24, 2011
Last verified: February 2011

December 26, 2005
February 24, 2011
December 2005
October 2009   (final data collection date for primary outcome measure)
tolerance of the patients in the both groups.
Same as current
Complete list of historical versions of study NCT00270491 on ClinicalTrials.gov Archive Site
  • - Response rates and duration of response.
  • - Haematological and non-haematological toxicities.
  • - Progression free survival.
  • - Overall survival.
Same as current
Not Provided
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Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Neoplasm Metastasis
  • Drug: Paclitaxel
  • Drug: Capecitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
October 2010
October 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00270491
TAXEL
Not Provided
Not Provided
ARCAGY/ GINECO GROUP
Not Provided
Principal Investigator: Rémy LARGILLIER, Physician Centre ANTOINE LACASSAGNE - NICE (FRANCE)
ARCAGY/ GINECO GROUP
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP