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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

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

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

Responsible Party:	Benedicte VOTAN, ARCAGY-GINECO
ClinicalTrials.gov Identifier:	NCT00525096 History of Changes
Other Study ID Numbers:	CELAROM
Study First Received:	September 3, 2007
Last Updated:	June 29, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Celecoxib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012