Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

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.

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

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