Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer - Full Text View

Sponsor:	ARCAGY/ GINECO GROUP
Information provided by:	ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:	NCT00525096

Purpose

To discover if the adding of a coxib increases the efficacy of the Aromasine.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: placebo Drug: Celecoxib Drug: Exemestane	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane Celecoxib

U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:

Progression free survival [ Time Frame: 5 years ]

Secondary Outcome Measures:

Objective response rate [ Time Frame: 6 months ]
Quality Of Life + pain [ Time Frame: 6 months ]
Overall survival [ Time Frame: 5 years ]
Tolerance [ Time Frame: 6 months ]

Enrollment:	157
Study Start Date:	July 2003
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
Placebo: Placebo Comparator Aromasin + placebo in place of Celebrex	Drug: placebo 2 tablets twice a day per os Drug: Exemestane Exemestane 25 mg per day per os
Celebrex: Experimental Aromasin + Celebrex	Drug: Celecoxib 2*200 mg tablets twice a day per os Drug: Exemestane Exemestane 25 mg per day per os

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525096

Sponsors and Collaborators

ARCAGY/ GINECO GROUP

Investigators

Principal Investigator:

Gilles FREYER, PhD

Centre Hospitalier Lyon Sud - France

More Information

No publications provided

Study ID Numbers:	CELAROM
Study First Received:	September 3, 2007
Last Updated:	September 3, 2007
ClinicalTrials.gov Identifier:	NCT00525096 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Exemestane
Antirheumatic Agents
Aromatase Inhibitors
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 05, 2009