- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00418236
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW
It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense.
At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects.
This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Buenos Aires, Argentina
-
-
-
-
-
Goiania, Brasil, 74175-080
-
Mato Grosso, Brasil, 78008-400
-
-
Sao Paulo
-
Sorocaba, Sao Paulo, Brasil, 18095-458
-
-
-
-
-
Sofia, Bulgaria, 1431
-
Sofia, Bulgaria, 1303
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V5Z 2N6
-
-
Manitoba
-
Winnipeg, Manitoba, Canadá, R3A 1M3
-
-
Quebec
-
Quebec City, Quebec, Canadá, G1V 3M7
-
Sherbrooke, Quebec, Canadá, J1H 4J6
-
-
-
-
-
Santiago, Chile
-
-
-
-
-
Zadar, Croacia, 23000
-
Zagreb, Croacia, 10000
-
-
-
-
-
Vejle, Dinamarca, DK-7100
-
-
-
-
California
-
San Diego, California, Estados Unidos, 92108
-
Upland, California, Estados Unidos, 91786
-
-
Idaho
-
Meridian, Idaho, Estados Unidos, 83642
-
-
Minnesota
-
Brooklyn Center, Minnesota, Estados Unidos, 55430
-
-
Montana
-
Billings, Montana, Estados Unidos, 59101
-
Bozeman, Montana, Estados Unidos, 59715
-
-
North Dakota
-
Bismark, North Dakota, Estados Unidos, 58503
-
Fargo, North Dakota, Estados Unidos, 58104
-
Jamestown, North Dakota, Estados Unidos, 58401
-
-
South Dakota
-
Watertown, South Dakota, Estados Unidos, 57201
-
-
-
-
-
Tallin, Estonia, 101 28
-
Tartu, Estonia, 50410
-
-
-
-
-
Agarismo, México, 11800
-
-
-
-
-
Amsterdam, Países Bajos, 1081 HV
-
-
-
-
-
Krakow, Polonia, 30510
-
Warszawa, Polonia, 02-341
-
-
-
-
-
Bucharest, Rumania, 70231
-
Cluj-Napoca, Rumania, 3400
-
Iasi, Jud. Iasi, Rumania, 6600
-
-
-
-
-
Johannesburg, Sudáfrica, 2196
-
Parow, Sudáfrica, 7500
-
Pretoria, Sudáfrica
-
Somerset West, Sudáfrica, 7130
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- Each subject must have participated or is currently participating in study 3068A1 301, and must satisfy all of the following criteria
- Has completed 24 months of treatment.
- Had a mammogram at the baseline visit and at the month 24 visit, and both are original films that are technically acceptable for reading.
- Was less than or equal to 62 years of age at the time of study randomization in the primary study.
- Was at least 80% compliant with test article administration.
- Did not take any medications 6 months prior to screening in the primary study or during the first 24 months of the study that could cause a change in breast density.
- Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion criteria.
- Was enrolled at a clinical site that is still participating in the primary study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Trial Manager, For Poland, WPWZMED@wyeth.com
- Investigador principal: Trial Manager, For Romania, WVPIMED@wyeth.com
- Investigador principal: Trial Manager, For South Africa, ZAFinfo@wyeth.com
- Investigador principal: Trial Manager, For Brazil, xavierl@wyeth.com
- Investigador principal: Trial Manager, For Mexico, gomezzlj@wyeth.com
- Investigador principal: Trial Manager, For Canada, clintrialparticipation@wyeth.com
- Investigador principal: Trial Manager, For Croatia, WPBUMED@wyeth.com
- Investigador principal: Trial Manager, For Argentina, Scheima@wyeth.com
- Investigador principal: Trial Manager, For Chile, scheima@wyeth.com
- Investigador principal: Trial Manager, For Denmark, medinfonord@wyeth.com
- Investigador principal: Trial Manager, For Estonia, WVPMED@wyeth.com
- Investigador principal: Trial Manager, For Bulgaria, WVPIMED@wyeth.com
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 3068A1-400
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer de mama
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University y otros colaboradoresTerminadoLa guía de aplicación clínica de Conebeam Breast CTPorcelana
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos