EXPLORATORY STUDY OF THE EFFECT OF THREE DIFFERENT LEVELS OF DOSES OF TAMOXIFEN (20, 40 Y 60 MG/DAY) OVER THE PLASMATIC CONCENTRATION OF THE MAIN ACTIVE TAMOXIFEN METABOLITE (ENDOXIFEN) IN PATIENTS WITH HORMONO-SENSITIVE BREAST CANCER, CARRIERS OF A CYP2D6 GENOTYPE POOR METABOLIZER”.Estudio exploratorio del efecto de tres diferentes niveles de dosis de tamoxifeno (20, 40 y 60 mg/día) sobre la concentración plasmática de su principal metabolito activo (endoxifeno) en pacientes con cáncer de mama hormonodependiente portadoras de un genotipo de CYP2D6 metabolizador lento”

Fundación de la Comunidad Valenciana Hospital Provincial de Castellón0 sitesSeptember 11, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: WOMEN WITH HORMONE-DEPENDENT RESECTED PRIMARY BREAST CANCER, WITHOUT EVIDENCE OF METASTATIC DISEASE AND CARRIERS OF A CYP2D6 GENOTYPE POOR METABOLIZER”.Cáncer de mama operado y sin diseminación metastásica (AJCC, 2002), con receptores hormonales positivos (receptor estrogénico RE y/o receptor de progesterona RP).Las pacientes deberán ser lentas metabolizadoras” de CYP2D6
Sponsor: Fundación de la Comunidad Valenciana Hospital Provincial de Castellón
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

September 11, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Fundación de la Comunidad Valenciana Hospital Provincial de Castellón

•Patients must meet all of the following inclusion criteria to be eligible for enrollement into the trial:
•·Female,18 years of age or older.
•·Karnofsky performance score \= 80\.
•·Histologically proven diagnosis of hormone\-dependent breast cancer, stage I, II, or III (T1\-3, Nx, M0\), without evidence of metastatic disease.
•·Patient must have received definitive surgery treatment for breast cancer ( lumpectomy or mastectomy) and must have completed adjuvant or neo\-adjuvant therapy if indicated.
•·Adjuvant treatment with tamoxifen must be indicated. At the inclusion time, the patient can be about starting the endocrine therapy or can have yet started it, but in this last case it must be planned to continue this treatment for at least 8 months more.
•·Patient with variant forms of the CYP2D6 gene corresponding to a poor metabolim of CYP2D6, as defined in ANEXO 2\.
•·Women of childbearing potencial must be using a medically accepted method of contraception. Postmenopausic women (non\-histerectomized) must remain amenorrheic during at least 12 months to be considered infertile (or at least 24 months in case of amenorrhea induced by adjuvant chemotherapy.
•·Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days before study inclusion.
•·Adequate haematological function as defined by haemoglobin \>10g/dL, absolute neutrophil count \>

•Patient with estrogen receptor AND progesterone receptor both negative breast cancer.
•Patients for whom tamoxifen is contraindicated ( history of deep vein thrombosis, endometrial hyperplasia, or abnormal vaginal bleeding), or known hypersensitivity to tamoxifen.
•Pregnant or breast feeding women. Patients of childbearing potential and serum or urine pregnancy test unknown or positive within 14 days before inclusion.
•Patients concurrently receiving any other hormone therapy or anti\-cancer therapy.
•Concomitant treatment for hot flushes and sweats.
•Concurrent treatment with strong inhibitors of CYP2D6 as the selective inhibitors of serotonine Reuptake SSRI (particularly paroxetine y fluoxetine) or other less potent inhibitors of CYP2D6 (as sertraline and citalopram among the SSRI, doxepine, celecoxib, difenhidramine, clorfeniramine, amiodarone, cimetidine, haloperidol y ticlopidine).
•Concomitant oral treatment with coumarin\-derivative anticoagulant therapy.
•Patients not willing or not being able to compliance with the protocol.
•9\.5\.Criterios de exclusión
•1\.Pacientes con tumores con receptores de estrógeno (RE) y receptores de progesterona ambos negativos.