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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Association Européenne de Recherche en Oncologie
ClinicalTrials.gov Identifier:
NCT00189631
First received: September 12, 2005
Last updated: December 7, 2005
Last verified: September 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Procedure: UFT/LV
Procedure: Observation
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association Européenne de Recherche en Oncologie:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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) < 2.
  • 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
  • Male patient
  • Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
  • History of high dose chemotherapy with bone marrow transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189631

Contacts
Contact: Annie Jouhaud + 33 1 43 77 72 10 annie.jouhaud@aero-eu.org

Locations
France
AERO Recruiting
Creteil, France, 94000
Contact: Laurent Zelek, MD     + 33 1 43 77 72 10     laurent.zelek@hmn.aphp.fr    
Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Bristol-Myers Squibb
Investigators
Principal Investigator: Jean-Francois Berdah, MD AERO
Principal Investigator: Laurent Zelek, MD AERO
Principal Investigator: Bruno Audhuy, MD AERO
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189631     History of Changes
Other Study ID Numbers: AERO-MB02
Study First Received: September 12, 2005
Last Updated: December 7, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013