Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525096
• Other study ID #: CELAROM
• Status: Completed
• Phase: Phase 3
• First received: September 3, 2007
• Last updated: June 29, 2011
• Start date: July 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• placebo
2 tablets twice a day per os
• Celecoxib
2*200 mg tablets twice a day per os
• Exemestane
Exemestane 25 mg per day per os

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		5 years
Secondary	Objective response rate		6 months
Secondary	Quality Of Life + pain		6 months
Secondary	Overall survival		5 years
Secondary	Tolerance		6 months