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To discover if the adding of a coxib increases the efficacy of the Aromasine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Aromasin + placebo in place of Celebrex |
|
| Celebrex | Experimental | Aromasin + Celebrex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 2 tablets twice a day per os |
| |
| Celecoxib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 6 months | |
| Quality Of Life + pain | 6 months | |
| Overall survival |
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Inclusion Criteria:
Femal patient aged > 18 years
Histologically proven breast cancer
Menopausal patient according to the following definition:
Oestradiol and/or progesterone positive receptors
Presence of one or several metastatic lesion:
Patient who can have received:
PS < 2
Adequate biological values
Patient who has clearly given her consent by signing on informed consent form prior to participation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles FREYER, PhD | Centre Hospitalier Lyon Sud - France | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
2*200 mg tablets twice a day per os |
|
|
| Exemestane | Drug | Exemestane 25 mg per day per os |
|
|
| 5 years |
| Tolerance | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |