A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies du sein+2
+ Néoplasmes du sein
+ Néoplasmes par site
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 février 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction. * Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug. * Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug. Secondary * Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients. * Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug. OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction). Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.53 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 20 à 45 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction * Undergoing mammography at least annually * No bilateral breast cancer or stage IV breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 20 to 45 Sex * Female Menopausal status * Premenopausal * No change in menstrual patterns within the past 6 months Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * No planned pregnancy within the next 5 years * No medical or psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for breast cancer Endocrine therapy * See Disease Characteristics * No prior tamoxifen for more than 1 month in duration Radiotherapy * Not specified Surgery * Not specified
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesVoir le site