Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

Original Study ID : CELAROM

NCT ID : NCT00525096

Brief Title : Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

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.

Brief Summary :

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

Source : ARCAGY/ GINECO GROUP

Overall Status : Active, not recruiting

Start Date : July 2003

End Date : December 2009

Completion Date : December 2009

Official Title : Phase 3

Phase : Interventional

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

Enrollment : 157

Verification Date : September 2007

First Received Date : September 3, 2007

Trial Eligibility

Criteria :
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

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

OutComes

Primary OutComes

Measure : Progression free survival

Time Frame : 5 years

Secondary OutComes

Measure : Objective response rate

Time Frame : 6 months

Measure : Quality Of Life + pain

Time Frame : 6 months

Measure : Overall survival

Time Frame : 5 years

Measure : Tolerance

Time Frame : 6 months

Interventions

Type : Drug

Name : placebo

Description : 2 tablets twice a day per os

Type : Drug

Name : Celecoxib

Description : 2*200 mg tablets twice a day per os

Type : Drug

Name : Exemestane

Description : Exemestane 25 mg per day per os

Clinical Trial Name - Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer