Revaree Plus for vaginal dryness in people with breast cancer
Evaluation of Revaree Plus in Women With Breast Cancer
This trial will test whether Revaree Plus can improve vaginal dryness and related discomfort in adults with hormone-receptor–positive stage 0–III breast cancer who are on tamoxifen, aromatase inhibitors, or SERMs.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07042581 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with confirmed stage 0–III hormone-receptor–positive breast cancer, currently on tamoxifen, aromatase inhibitors, or SERMs, with no clinical evidence of disease and who report bothersome vaginal symptoms (VAS ≥4) are the intended participants.
Not a fit: People with other active cancers, those not on endocrine therapy, those with low symptom burden (VAS <4), or who cannot consent or complete study procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Revaree Plus could reduce vaginal dryness and pain with intercourse, improving sexual comfort and quality of life for breast cancer survivors on endocrine therapy.
How similar studies have performed: Non-hormonal vaginal moisturizers and lubricants have provided symptom relief for some breast cancer survivors in prior studies, but evidence varies and this specific product has limited published trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basking Ridge, New Jersey and 6 other locations
- 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)
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.