A Study of Vulvovaginal Symptoms in Premenopausal Stage 0-III Breast Cancer Patients Treated on Aromatase Inhibitors and Ovarian Suppression

Overview

Información sobre este estudio

The purpose of this study is to evaluate the change of vulvovaginal symptoms score from baseline to 6 months in premenopausal women with stage 0-III breast cancer treating with ovarian suppression in combination with aromatase inhibitors.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of adenocarcinoma of the breast stage 0-III.
  • Evidence of hormone sensitivity with estrogen receptor (ER) and/or progesterone receptor (PR) positive ≥ 1%) of primary tumor tissue.
  • Premenopausal either by continuation of menstrual period or estradiol level ≥ 10 pg/ml.
  • Will be starting on ovarian suppression in combination with aromatase inhibitor (letrozole, anastrozole, or exemestane).
  • ECOG Performance Status (PS) ≤ 3.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up.

Exclusion Criteria

  • Self-report of vaginal itching, dryness, or dyspareunia at baseline.
  • Previous history of pelvic reconstruction surgery.
  • Co-morbid systemic illnesses or oproper assessment of the treatment.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
    • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Brenda Ernst, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20453745

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