Metastatic Breast Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 157 |
Est. completion date | December 2004 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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ARCAGY/ GINECO GROUP |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | 5 years | ||
Secondary | Objective response rate | 6 months | ||
Secondary | Quality Of Life + pain | 6 months | ||
Secondary | Overall survival | 5 years | ||
Secondary | Tolerance | 6 months |
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