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

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: NCT00189631
Recruitment Status : Unknown
Verified September 2005 by Association Européenne de Recherche en Oncologie.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : December 8, 2005
Bristol-Myers Squibb
Information provided by:
Association Européenne de Recherche en Oncologie

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.

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

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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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:

  • 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

Information from the National Library of Medicine

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): NCT00189631

Contact: Annie Jouhaud + 33 1 43 77 72 10

AERO Recruiting
Creteil, France, 94000
Contact: Laurent Zelek, MD    + 33 1 43 77 72 10   
Sponsors and Collaborators
Association Européenne de Recherche en Oncologie
Bristol-Myers Squibb
Principal Investigator: Jean-Francois Berdah, MD AERO
Principal Investigator: Laurent Zelek, MD AERO
Principal Investigator: Bruno Audhuy, MD AERO Identifier: NCT00189631     History of Changes
Other Study ID Numbers: AERO-MB02
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 8, 2005
Last Verified: September 2005

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