- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00096369
Tamoxifen in Preventing Breast Cancer in Women at Increased Risk for Breast Cancer
An Exploratory Study to Identify Potential Surrogate Endpoint Biomarkers That Are Modulated by Tamoxifen vs. Placebo in Women With an Increased Risk for Breast Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of tamoxifen may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying tamoxifen to see how well it works compared to placebo in preventing breast cancer in women who are at increased risk for the disease.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Compare molecular markers of proliferation and apoptosis in breast epithelial tissue of women at increased risk for breast cancer treated with tamoxifen vs placebo.
- Compare the modulation of markers of genomic instability in breast epithelial tissue of patients treated with these drugs.
- Compare serum levels of IGF-1, IGF-2, and IGFBP-3 of these patients at baseline and after treatment with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estimated 5-year breast cancer risk (1.67-5% vs ≥ 5%), presence of atypical ductal hyperplasia (yes vs no), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen once daily.
- Arm I: Patients receive oral placebo once daily. Treatment in both arms continues for 3 months in the absence of invasive breast cancer or unacceptable toxicity.
Patients undergo core needle biopsy and fine needle aspiration biopsy at baseline and then at the completion of study treatment (for premenopausal patients); exactly 84 days after the first biopsy (for postmenopausal patients); or on the first or second day of the menstrual cycle on or after 84 days (during the third menstrual cycle) after the first dose of study medication (for patients with irregular menses).
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 130 patients (65 per arm) will be accrued for this study within 30 months.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- Oklahoma University Cancer Institute
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Texas
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Dallas, Texas, États-Unis, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Houston, Texas, États-Unis, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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San Antonio, Texas, États-Unis, 78229
- Cancer Therapy and Research Center
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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 breast cancer, as defined by 1 of the following criteria:
- Histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only
Composite increased breast cancer risk of ≥ 1.67% over 5 years, based on the following criteria:
- Age
- Number of first-degree female relatives with breast cancer
One or more prior breast biopsies
- Fine-needle aspiration cytology of a non-cystic lesion in lieu of an open biopsy is considered a biopsy
- Prior diagnosis of atypical hyperplasia of the breast
- Age at first live birth
- Nulliparity
- Race
- Age at onset of menarche
- No prior or suspected invasive breast cancer or ductal carcinoma in situ
- No clinical evidence of malignancy by physical examination, including a breast examination within the past 3 months
- No evidence of suspicious or malignant disease or uncharacterized lesions on bilateral mammogram within the past 6 months
- Normal gynecologic examination, including a bimanual pelvic examination and, if indicated, pap smear within the past 12 months
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 35 and over
Sex
- Female
Menopausal status
- Premenopausal and ovulating*, defined as having regular menses for the past 6 months OR irregular menses with follicular phase (i.e., day 3) follicle-stimulating hormone level < 20 mIU/mL OR
- Postmenopausal NOTE: * Ovulation is determined by day 21 progesterone level > 3 ng/mL
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Complete blood count normal
- No active bleeding disorder (e.g., qualitative or quantitative platelet abnormality, hemophilia, or von Willebrand's disease)
Hepatic
- Liver function tests normal
Renal
- Not specified
Cardiovascular
- No prior deep-vein thrombosis except a single occurrence related to lower extremity trauma
- No prior cerebral vascular accident
- No prior transient ischemic attack
Pulmonary
- No prior pulmonary embolus except a single occurrence related to lower extremity trauma
Other
- No saline or silicone breast implants
- No known allergy to tamoxifen
- No macular degeneration
- No malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No nonmalignant disease that would preclude administration of tamoxifen
- No psychiatric condition, including a history of clinical depression or addictive disorder, that would preclude giving informed consent or study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic adjuvant chemotherapy for LCIS
Endocrine therapy
- No prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators
At least 3 months since prior and no concurrent use of any of the following drugs:
- Estrogen or progesterone replacement therapy
- Oral contraceptives
- Androgens
- Luteinizing hormone-releasing hormone analogs
- Prolactin inhibitors
- Antiandrogens
- Steroids
- No concurrent steroids for asthma
Radiotherapy
- No prior radiotherapy for LCIS
Surgery
- No prior bilateral prophylactic mastectomy
- No prior mastectomy for LCIS
Other
- Concurrent nonhormonal medications allowed
- No concurrent warfarin or cholestyramine
No prior or concurrent participation in any other cancer prevention study
- Patients treated with placebo on protocol NSABP-P-1 are eligible
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Masquage: Double
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Plasma levels of hormones and binding proteins as measured by ELISA, IHC, and TUNEL at baseline and 3 months
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Markers of proliferation and apoptosis in breast cells as measured by quantitative MSP at baseline and 3 months
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Promoter-region methylation as assessed by microarrays at baseline and 3 months
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Gene expression
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: David M. Euhus, MD, Simmons Cancer Center
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
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs mammaires
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Antagonistes hormonaux
- Agents de conservation de la densité osseuse
- Antagonistes des œstrogènes
- Modulateurs sélectifs des récepteurs aux œstrogènes
- Modulateurs des récepteurs aux œstrogènes
- Tamoxifène
Autres numéros d'identification d'étude
- CDR0000393444; V-10604
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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