NCT00263705

Brief Summary

Determination of guidelines regarding the use of adjuvant chemotherapy for early breast cancer in this population of Patients over 70 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 9, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

6.6 years

First QC Date

September 13, 2005

Last Update Submit

February 23, 2011

Conditions

Elderly PatientsBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • safety of capecitabine in ederly

    safety of capecitabine in ederly

    1 year

Study Arms (1)

capecitabine

EXPERIMENTAL

capecitabine 2000 mg/m² daily

Drug: Adjuvant capecitabineDrug: capecitabine in aduvant setting

Interventions

Adjuvant capecitabineDRUG

Capecitabine 2000 mg/m² daily six cycles

Also known as: Xeloda
capecitabine
capecitabine in aduvant settingDRUG

capecitabine in aduvant setting in ederly with breast cancer

Also known as: Xeloda
capecitabine

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women aged ³70 years
  • Histologic diagnosis of early breast cancer for which the treating physician considers adjuvant chemotherapy to be beneficial. Recommended situations are for example:
  • endocrine non responsive (ER- and PgR -) and pT\>1 cm, any T if N+ OR
  • endocrine responsiveness doubtful (ER and/or PgR- or poor \[3 to-5 according to Harvey score (12) or £ 30% of positive cells by immunohistochemistry) and other risk factors (pT³2 cm or N+ or G3 or Her-2/neu positive, etc.) OR
  • endocrine responsive (ER and PgR \> 5 according to Harvey score or \> 30% of positive cells by immunohistochemistry) and at least two risk factors (pT³ 2 cm, N+, G3, Her-2/neu positive, etc.) OR
  • Very high risk (N\>3) any ER/PgR.
  • ECOG Performance status £ 1
  • No previous exposition to chemotherapy in the neoadjuvant setting
  • Adequate organ function including:
  • neutrophils ³ 1.5 x 109 /l
  • platelets ³100 x 109 / l
  • bilirubin \< 1.25 x upper normal limit for the institution
  • transaminases \< 2.5 x upper normal limit for the institution
  • calculated creatinine clearance of \> 30ml/min (using the Crockoft and Gault formula)
  • absence of
  • +6 more criteria

You may not qualify if:

  • N/A-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Chantal Bernard, MD

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

December 9, 2005

Study Start

January 1, 2003

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

BE(1)