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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00189631
• Other study ID #: AERO-MB02
• Status: Recruiting
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 7, 2005

Study information

• Verified date: September 2005
• Source: Association Européenne de Recherche en Oncologie
• Contact: Annie Jouhaud
• Phone: + 33 1 43 77 72 10
• Email: annie.jouhaud[@]aero-eu.org
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• UFT/LV

• Observation

Locations

Country	Name	City	State
France	AERO	Creteil

Sponsors (2)

Lead Sponsor	Collaborator
Association Européenne de Recherche en Oncologie	Bristol-Myers Squibb

Country where clinical trial is conducted

France,