Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer
Information source: ARCAGY/ GINECO GROUP
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Breast Cancer
Intervention: placebo (Drug); Celecoxib (Drug); Exemestane (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ARCAGY/ GINECO GROUP Official(s) and/or principal investigator(s): Gilles FREYER, PhD, Principal Investigator, Affiliation: Centre Hospitalier Lyon Sud - France
Summary
To discover if the adding of a coxib increases the efficacy of the Aromasine.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Progression free survival
Secondary outcome: Objective response rateQuality Of Life + pain Overall survival Tolerance
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2003
Last updated: June 29, 2011
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