RecruitingPhase 4NCT07042581

A Study of Revaree Plus in People With Breast Cancer

Evaluation of Revaree Plus in Women With Breast Cancer

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

60 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Stage III Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage 0 Breast Cancer Stage 0 Breast Carcinoma Stage II Breast Carcinoma Stage III Breast Carcinoma

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

≥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 Criteria5

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