Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

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.

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

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: placebo; Drug: Exemestane; Drug: Celecoxib

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Aromasin
Experimental: Celebrex; Aromasin + Celebrex	Drug: Exemestane; Exemestane 25 mg per day per os; Other Names: Aromasin; Drug: Celecoxib; 2*200 mg tablets twice a day per os; Other Names: Celebrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	5 years
Objective response rate	6 months
Quality Of Life + pain	6 months
Tolerance	6 months

Collaborators and Investigators

• Sponsor: ARCAGY/ GINECO GROUP
• Investigators: Principal Investigator: Gilles FREYER, PhD, Centre Hospitalier Lyon Sud - France

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: September 3, 2007
• First Submitted That Met QC Criteria: September 3, 2007
• First Posted (Estimate): September 5, 2007

Study Record Updates

• Last Update Posted (Estimate): June 30, 2011
• Last Update Submitted That Met QC Criteria: June 29, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Cyclooxygenase 2 Inhibitors; Celecoxib; Exemestane
• Other Study ID Numbers: CELAROM