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Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00525096
First received: September 3, 2007
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  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 3

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:

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 June 18, 2013