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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.


Phase 3
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

5 years

Principal Investigator

Gilles FREYER, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Lyon Sud - France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CELAROM

NCT ID:

NCT00525096

Start Date:

July 2003

Completion Date:

December 2004

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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