Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer
NCT ID: NCT00525096
Last Updated: 2011-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
157 participants
INTERVENTIONAL
2003-07-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Aromasin + placebo in place of Celebrex
placebo
2 tablets twice a day per os
Exemestane
Exemestane 25 mg per day per os
Celebrex
Aromasin + Celebrex
Celecoxib
2\*200 mg tablets twice a day per os
Exemestane
Exemestane 25 mg per day per os
Interventions
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placebo
2 tablets twice a day per os
Celecoxib
2\*200 mg tablets twice a day per os
Exemestane
Exemestane 25 mg per day per os
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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ARCAGY-GINECO
Principal Investigators
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Gilles FREYER, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Lyon Sud - France
Other Identifiers
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CELAROM
Identifier Type: -
Identifier Source: org_study_id