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OpenTrials
Completed

NCT Number: NCT00525096

Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

2 tablets twice a day per os

Celecoxib

Drug

2*200 mg tablets twice a day per os

Other names: Celebrex

Exemestane

Drug

Exemestane 25 mg per day per os

Other names: Aromasin

Primary outcomes

  1. Progression free survival

    Time frame: 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 5, 2007
Registry last updated
Jun 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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