Evaluation of Revaree Plus in Women With Breast Cancer

What this Trial Is About

Researchers are evaluating Revaree Plus, a hyaluronic acid vaginal suppository, to see if it improves vaginal health in women experiencing dryness symptoms during breast cancer treatment. The study focuses on women with stage 0 to III hormone-receptor positive breast cancer who are currently on maintenance therapy or have completed their primary treatment. This Phase 4 study is sponsored by Memorial Sloan Kettering Cancer Center and aims to provide insights into managing vaginal symptoms related to estrogen deprivation during breast cancer care. Participants will receive Revaree Plus as the investigational drug. The study targets women with hormone-receptor positive breast cancer who are on aromatase inhibitors, tamoxifen, or Selective Estrogen Receptor Modulators (SERM). Treatment will be monitored over 8 weeks to assess changes in vaginal health symptoms. The main measurement is the change in the Vaginal Assessment Scale from baseline to 8 weeks, focusing on symptoms such as vaginal dryness, pain with intercourse, or discomfort. Women in the study will complete questionnaires in English or Spanish to report symptoms and overall vaginal health. Researchers will track symptom changes using the Vaginal Assessment Scale and monitor safety and adherence throughout the 8-week period. Participants must provide informed consent, and no healthy volunteers are included. The study will continue until June 2029, with all care related to the study provided during this time.

A Study of Revaree Plus in People With Breast Cancer