NCT07042581PHASE4Recruiting
A Study of Revaree Plus in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
Start Date
6/20/2025
Completion Date
6/20/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Revaree Plus
Conditions
Breast CancerStage 0 Breast CancerStage I Breast CancerStage II Breast CancerStage III Breast CancerStage 0 Breast CarcinomaStage II Breast CarcinomaStage III Breast CarcinomaHormone-receptor-positive Breast CancerHormone Receptor Positive Breast CarcinomaHormone Receptor Positive Malignant Neoplasm of Breast
Locations
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York 11553
United States