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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Celecoxib
Exemestane
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Antineoplastic Agents
Aromatase Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014