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Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525096
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : June 30, 2011
Information provided by:

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

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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

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

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00525096

Sponsors and Collaborators
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Principal Investigator: Gilles FREYER, PhD Centre Hospitalier Lyon Sud - France
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Responsible Party: Benedicte VOTAN, ARCAGY-GINECO Identifier: NCT00525096    
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:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists