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Clinical Trials/NCT00189631
NCT00189631
Unknown
Phase 3

UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy

Association Européenne de Recherche en Oncologie1 site in 1 countrySeptember 19, 2005
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ConditionsBreast Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Association Européenne de Recherche en Oncologie
Locations
1
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.

Registry
clinicaltrials.gov
Start Date
September 19, 2005
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Association Européenne de Recherche en Oncologie

Eligibility Criteria

Inclusion Criteria

  • •metastatic breast cancer
  • •objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
  • •time period between the end of chemotherapy and randomization \< 4 weeks
  • •age over 18 years
  • •Performance status (OMS) \<
  • •Life expectancy \> 3 months
  • •Biological criteria before randomization: Neutrophiles \> 1.5 x 109 G/L; Pl. \> 100 x 109 G/L; Hb \> 10 g/dl; Creatininemia \< 1,5 UNL; Bili. \< 2 UNL; Transaminases \< 2,5 UNL; Alcalines Phosphatases \< 2,5 UNL
  • •Signed written informed consent

Exclusion Criteria

  • •Metastatic breast cancer having received more than one chemotherapy line.
  • •Tumor progression under chemotherapy
  • •Free interval between primary tumor and metastases \> 5 years, with estrogen receptors and without visceral metastases
  • •Free interval between primary tumor and metastases \< 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
  • •Concomitant hormonotherapy
  • •Other cancer
  • •Symptomatic brain metastases
  • •Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF \< 50% or coronary insufficiency
  • •Psychiatric disorder
  • •Other concomitant trial

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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