Metastatic Breast Cancer
Conditions
Brief summary
To discover if the adding of a coxib increases the efficacy of the Aromasine.
Interventions
DRUGplacebo
2 tablets twice a day per os
DRUGCelecoxib
2\*200 mg tablets twice a day per os
DRUGExemestane
Exemestane 25 mg per day per os
Sponsors
ARCAGY/ GINECO GROUP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | 6 months |
| Quality Of Life + pain | 6 months |
| Overall survival | 5 years |
| Tolerance | 6 months |
Outcome results
None listed