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Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

Information source: ARCAGY/ GINECO GROUP
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Breast Cancer

Intervention: placebo (Drug); Celecoxib (Drug); Exemestane (Drug)

Phase: Phase 3

Status: Completed


Official(s) and/or principal investigator(s):
Gilles FREYER, PhD, Principal Investigator, Affiliation: Centre Hospitalier Lyon Sud - France


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Progression free survival

Secondary outcome:

Objective response rate

Quality Of Life + pain

Overall survival



Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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


Locations and Contacts

Additional Information

Starting date: July 2003
Last updated: June 29, 2011

Page last updated: August 20, 2015

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