Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Celecoxib; Exemestane

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