A Study of Revaree Plus in People With Breast Cancer
Evaluation of Revaree Plus in Women With Breast Cancer
1 other identifier
interventional
60
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 breast-cancer
Started Jun 2025
Typical duration for phase_4 breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2025
CompletedStudy Start
First participant enrolled
June 20, 2025
CompletedFirst Posted
Study publicly available on registry
June 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2029
February 6, 2026
February 1, 2026
4 years
June 20, 2025
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Vaginal Assessment Scale from baseline to 8 weeks
The primary study objective is to evaluate whether vaginal health improves from baseline to 8 weeks of treatment with Revaree Plus as measured by the Vaginal Assessment Scale
8 weeks
Study Arms (1)
Hormone-receptor positive breast cancer participants
EXPERIMENTALParticipants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer
Interventions
Revaree Plus is a hyaluronic acid vaginal suppository
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shari Goldfarb, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2025
First Posted
June 29, 2025
Study Start
June 20, 2025
Primary Completion (Estimated)
June 20, 2029
Study Completion (Estimated)
June 20, 2029
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.