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

Overview

About this study

To 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brenda Ernst, M.D.

Open for enrollment

Contact information:

Pulkit Mathur

(904)953-3803

Mathur.Pulkit@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453745

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