NCT00189631

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

December 8, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

December 7, 2005

Conditions

Breast Cancer

Interventions

UFT/LVPROCEDURE
ObservationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AERO

Créteil, 94000, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Jean-Francois Berdah, MD

    AERO

    PRINCIPAL INVESTIGATOR

  • Laurent Zelek, MD

    AERO

    PRINCIPAL INVESTIGATOR

  • Bruno Audhuy, MD

    AERO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Jouhaud

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Last Updated

December 8, 2005

Record last verified: 2005-09

Locations

FR(1)