A Study of Revaree Plus in People With Breast Cancer
Recruiting now · Phase 4
Conditions studied: Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage 0 Breast Carcinoma, Stage II Breast Carcinoma, Stage III Breast Carcinoma, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast
In brief
The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.
Key facts
- Study ID
- NCT07042581
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 60
- Starts
- 2025-06-20
- Expected to finish
- 2029-06-20
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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 is running
- Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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