Recruiting

Revaree Plus

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07042581

Conditions

Breast Cancer

Stage 0 Breast Cancer

Stage I Breast Cancer

Stage II Breast Cancer

Stage III Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Revaree Plus

Study Details

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.

Conditions

Breast Cancer

Stage 0 Breast Cancer

Stage I Breast Cancer

Stage II Breast Cancer

Stage III Breast Cancer

Study ID

NCT07042581

Start date

Jun 20, 2025

Status verified date

Feb, 2026

Completion date

Jun 20, 2029

Anticipated

Primary completion date

Jun 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hormone-receptor positive breast cancer participants

Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer

Interventions

Revaree Plus

Revaree Plus is a hyaluronic acid vaginal suppository

Primary outcome measure

  • Change in Vaginal Assessment Scale from baseline to 8 weeks [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Shari Goldfarb, MD

646-888-5080goldfars@mskcc.org

Jeanne Carter, PhD

646-888-5076carterj@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Shari Goldfarb, MD

646-888-5080

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Breast Cancer
  • Stage 0 Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • Stage 0 hormone receptor positive breast cancer
  • Stage I hormone receptor positive breast cancer
  • Stage II hormone receptor positive breast cancer
  • Stage III hormone receptor positive breast cancer
  • Revaree
  • 24-374
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-06.