A Study of Revaree Plus in People With Breast Cancer

Not Applicable

Recruiting

• Conditions: 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
• Interventions: Drug: Revaree Plus

• Registration Number: NCT07042581
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-20
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Primary Completion: 2029-06-20
• Study Completion: 2029-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 chemotherapy or radiation therapy (and can be on maintenance therapy)
• Currently on an aromatase inhibitor or tamoxifen
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hormone-receptor positive breast cancer participants	Revaree Plus	Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer

Primary Outcome Measures

Name	Time	Method
Change in Vaginal Assessment Scale from baseline to 8 weeks	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only); 🇺🇸 Uniondale, New York, United States