Revaree Plus for vaginal dryness in people with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study enrolls adults (≥18) with stage 0–III hormone-receptor–positive breast cancer who report bothersome vaginal dryness (VAS score ≥4) while on endocrine therapy. Participants who have completed primary therapy or are on maintenance therapy and have no clinical evidence of disease will receive Revaree Plus and complete symptom questionnaires in English or Spanish. The trial is conducted under the auspices of Memorial Sloan Kettering Cancer Center with consent handled at several affiliated New Jersey locations. Outcomes focus on changes in vaginal symptoms and patient-reported measures of comfort and sexual function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years of age at the time of signing informed consent.
* Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC
* Able to complete study questionnaires in English or Spanish
* Breast cancer patients must have completed primary therapy (surgery, and/or chemotherapy, and/or radiation therapy) or currently on maintenance therapy
* Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)
* Currently have no clinical evidence of disease
* Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\])
* A total score of 4 or greater in VAS
* Without history of other cancers (excluding non-melanoma skin cancer)
* Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study

Exclusion Criteria:

* Inability to provide informed consent
* Vaginal bleeding of unknown etiology within 12 months of study entry
* Currently taking hormone replacement therapy \[local or systemic\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
* Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
* No known allergies to any ingredients in 10mg HLA suppository

Where it's running

• Memorial Sloan Kettering Basking Ridge (Consent Only)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent Only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Consent Only)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Shari Goldfarb, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Shari Goldfarb, MD
• Email: goldfars@mskcc.org
• Phone: 646-888-5080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.