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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00189631
Enrollment
Unknown
Registered
2005-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2005-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

PROCEDUREUFT/LV
PROCEDUREObservation

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
Association Européenne de Recherche en Oncologie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Countries

France

Contacts

Primary ContactAnnie Jouhaud
annie.jouhaud@aero-eu.org+ 33 1 43 77 72 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026