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

A

Association Européenne de Recherche en Oncologie

Status and phase

Unknown
Phase 3

Conditions

Breast Cancer

Treatments

Procedure: Observation
Procedure: UFT/LV

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00189631
AERO-MB02

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Annie Jouhaud

Data sourced from clinicaltrials.gov

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