NCT00525096

Brief Summary

To discover if the adding of a coxib increases the efficacy of the Aromasine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2003

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

July 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

September 3, 2007

Last Update Submit

June 29, 2011

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    5 years

Secondary Outcomes (4)

  • Objective response rate

    6 months

  • Quality Of Life + pain

    6 months

  • Overall survival

    5 years

  • Tolerance

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Aromasin + placebo in place of Celebrex

Drug: placeboDrug: Exemestane

Celebrex

EXPERIMENTAL

Aromasin + Celebrex

Drug: CelecoxibDrug: Exemestane

Interventions

placeboDRUG

2 tablets twice a day per os

Placebo
CelecoxibDRUG

2\*200 mg tablets twice a day per os

Also known as: Celebrex
Celebrex
ExemestaneDRUG

Exemestane 25 mg per day per os

Also known as: Aromasin
CelebrexPlacebo

Eligibility Criteria

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

You may qualify if:

  • Femal patient aged \> 18 years
  • Histologically proven breast cancer
  • Menopausal patient according to the following definition:
  • amenorrhoea \> 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
  • surgical ovariectomy
  • treatment by LHRH analog
  • ovarian suppression by radiotherapy
  • amenorrhoea induced by chemotherapy \> 1 year
  • Oestradiol and/or progesterone positive receptors
  • Presence of one or several metastatic lesion:
  • mesurable lesion
  • bone metastase were detected by bone scintigraphy
  • Patient who can have received:
  • Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
  • Metastatic Treatment by chemotherapy
  • +3 more criteria

You may not qualify if:

  • Patient previously treated with hormonotherapy in metastatic phase
  • Antecedent of treatment with aromatase inhibitors
  • local relapse (with the exception of cutaneous thoracic nodes)
  • Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxibexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gilles FREYER, PhD

    Centre Hospitalier Lyon Sud - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2007

First Posted

September 5, 2007

Study Start

July 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

June 30, 2011

Record last verified: 2011-06