- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00238316
Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density
A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high breast density.
PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Determine the proportion of postmenopausal women who are at increased risk for the development or recurrence of breast cancer, based on high breast density (≥ grade 4), who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole for 1 year.
Secondary
- Determine whether a decrease in breast density grade is sustained at 1 year in patients treated with this drug.
- Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline in these patients.
- Determine the percentage of patients with breast tissue hyperplasia and atypical hyperplasia, as assessed by histopathological examination of breast tissue biopsies, before and after treatment with this drug.
- Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after cessation of this drug in these patients.
- Compare changes in predetermined specific parameters of safety at the end of 1 year of treatment with this drug with baseline evaluations of these patients.
- Determine whether modifications of these predetermined specific parameters of safety are sustained 1 year after cessation of treatment with this drug in these patients.
- Determine the general safety of 1 year of treatment with this drug in these patients.
- Compare the effects of this drug on menopause-specific quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to breast density grade (4/6 vs 5/6 vs 6/6). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for 1 year in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once daily for 1 year in the absence of unacceptable toxicity.
Menopause-specific quality of life is assessed at baseline and then at 12 and 24 months.
After completion of study treatment, patients are followed at 6 months and 1 year.
PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study within 12 months.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 1Y2
- Hamilton Osteoporosis Diagnostic Services
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Regional Cancer Centre - General Campus
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St. Catharines, Ontario, Canada, L2R 5K3
- St. Catharines General Hospital at Niagara Health System
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H2W 1T8
- Hotel Dieu de Montreal
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, États-Unis, 02115-6084
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
At increased risk for the development or recurrence of breast cancer, as defined by 1 of the following:
Baseline mammogram indicating mammographic density occupying ≥ 25% (grade 4/6, 5/6, or 6/6) of the breast tissue
- No suspicion of breast cancer, unless subsequently ruled out
Prior ductal carcinoma in situ (DCIS)
- Untreated disease OR > 6 months since completion of adjuvant endocrine therapy
- Receptor status of lesion is not required
Prior invasive breast cancer
- Breast cancer must have been surgically removed at time of original diagnosis with no evidence of metastases
- No clinical evidence of breast cancer
Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L2-L4 postero-anterior (PA) spine and hip performed within past 6 months
- Bone mass density T-score of either PA spine or hip must be ≥ 2.0 SD below the mean peak bone mass in young normal woman
- Stable chronic leukemia allowed
Hormone receptor status:
- Hormone receptor-negative, -positive, or -equivocal tumor
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
Menopausal status
Postmenopausal, as defined by 1 of the following:
- Over 55 years of age with spontaneous cessation of menses for ≥ 1 year
- 55 years of age and under with spontaneous cessation of menses for ≤ 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy) AND follicle-stimulating hormone level > 34.4 IU/L
- Bilateral oophorectomy
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No recent unstable myocardial infarction
- No prior stroke
- No high blood pressure
- No other uncontrolled cardiovascular disease
Other
- Other prior malignancies without metastatic disease allowed
- Willing and able to complete quality of life questionnaires in either English or French
- No uncontrolled metabolic or endocrine disease
- No malabsorption syndrome
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 3 months since prior and no concurrent hormone replacement therapy or raloxifene
- At least 6 months since prior tamoxifen
- No concurrent steroid therapy
- No concurrent selective estrogen-receptor modulators
- No other concurrent endocrine or hormonal therapy
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: Placebo
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2.5 mg PO daily for one 1 year
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Comparateur actif: Létrozole
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2.5 mg PO daily for 1 year
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Percentage change of the BMD parameters from baseline BMD values
Délai: 7 years
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7 years
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Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values
Délai: 7 years
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7 years
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs mammaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Hormones, substituts hormonaux et antagonistes hormonaux
- Antagonistes hormonaux
- Inhibiteurs de l'aromatase
- Inhibiteurs de la synthèse des stéroïdes
- Antagonistes des œstrogènes
- Létrozole
Autres numéros d'identification d'étude
- MAP1
- CAN-NCIC-MAP1 (Autre identifiant: PDQ Identifier)
- CDR0000445442 (Autre identifiant: PDQ)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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