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Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00525096
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: placebo Drug: Celecoxib Drug: Exemestane Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : July 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 months ]
  2. Quality Of Life + pain [ Time Frame: 6 months ]
  3. Overall survival [ Time Frame: 5 years ]
  4. Tolerance [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525096


Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Gilles FREYER, PhD Centre Hospitalier Lyon Sud - France

Responsible Party: Benedicte VOTAN, ARCAGY-GINECO
ClinicalTrials.gov Identifier: NCT00525096     History of Changes
Other Study ID Numbers: CELAROM
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists