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A Study of Revaree Plus in People With Breast Cancer
RECRUITINGPhase 4Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 4
SponsorMemorial Sloan Kettering Cancer Center
Started2025-06-20
Est. completion2029-06-20
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations7 sites
View on ClinicalTrials.gov →
NCT07042581
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
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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
Conditions12
Breast CancerCancerHormone Receptor Positive Breast CancerHormone Receptor Positive Breast CarcinomaHormone Receptor Positive Malignant Neoplasm of BreastStage 0 Breast CancerStage 0 Breast CarcinomaStage I Breast CancerStage II Breast CancerStage II Breast Carcinoma
Locations7 sites
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Shari Goldfarb, MD646-888-5080
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Shari Goldfarb, MD646-888-5080
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Shari Goldfarb, MD646-888-5080
Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only)
Commack, New York, 11725
Shari Goldfarb, MD646-888-5080
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Shari Goldfarb, MD646-888-5080
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Actively Recruiting
PhasePhase 4
SponsorMemorial Sloan Kettering Cancer Center
Started2025-06-20
Est. completion2029-06-20
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations7 sites
View on ClinicalTrials.gov →
NCT07042581