Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 3, 2007

Last Updated Date

September 3, 2007

Start Date ^ICMJE

July 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Progression free survival [ Time Frame: 5 years ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Objective response rate [ Time Frame: 6 months ]
Quality Of Life + pain [ Time Frame: 6 months ]
Overall survival [ Time Frame: 5 years ]
Tolerance [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

Official Title ^ICMJE

A Multicenter Randomized Phase III, Double-Blind Study Comparing Efficacy of the Association of Exemestane and Celecoxib Versus Exemestane and Placebo in Menopausal Patients With Metastatic Breast Cancer.

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: placebo
Drug: Celecoxib
Drug: Exemestane

Study Arms / Comparison Groups

Placebo Comparator: Aromasin + placebo in place of Celebrex
Experimental: Aromasin + Celebrex

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

157

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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
PS < 2
Adequate biological values
Patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00525096

Responsible Party

Study ID Numbers ^ICMJE

CELAROM

Study Sponsor ^ICMJE

ARCAGY/ GINECO GROUP

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gilles FREYER, PhD

Centre Hospitalier Lyon Sud - France

Information Provided By

ARCAGY/ GINECO GROUP

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP