Clinical trial · Interventional
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.
NCT00525096CI-TRIAL-00005142completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To discover if the adding of a coxib increases the efficacy of the Aromasine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Aromasin + placebo in place of Celebrex
- interventionNames
- Drug: placebo
- Drug: Exemestane
- type
- EXPERIMENTAL
- label
- Celebrex
- description
- Aromasin + Celebrex
- interventionNames
- Drug: Celecoxib
- Drug: Exemestane
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.