RECRUITING

A Study of Revaree Plus in People With Breast Cancer

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Conditions

Breast CancerStage 0 Breast CancerStage I Breast CancerStage II Breast CancerStage III Breast CancerStage 0 Breast CarcinomaStage II Breast CarcinomaStage III Breast CarcinomaHormone-receptor-positive Breast CancerHormone Receptor Positive Breast CarcinomaHormone Receptor Positive Malignant Neoplasm of BreastStage 0 hormone receptor positive breast cancerStage I hormone receptor positive breast cancerStage II hormone receptor positive breast cancerStage III hormone receptor positive breast cancerRevaree24-374Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Revaree Plus in Women With Breast Cancer

Quick Facts

Study Start:2025-06-20
Study Completion:2029-06-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07042581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age at the time of signing informed consent.
  2. * Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC
  3. * Able to complete study questionnaires in English or Spanish
  4. * Breast cancer patients must have completed chemotherapy or radiation therapy (and can be on maintenance therapy)
  5. * Currently on an aromatase inhibitor or tamoxifen
  6. * Currently have no clinical evidence of disease
  7. * Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\])
  8. * A total score of 4 or greater in VAS
  9. * Without history of other cancers (excluding non-melanoma skin cancer)
  10. * 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
  1. * Inability to provide informed consent
  2. * Vaginal bleeding of unknown etiology within 12 months of study entry
  3. * Currently taking hormone replacement therapy \[local or systemic\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
  4. * Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)
  5. * No known allergies to any ingredients in 10mg HLA suppository

Contacts and Locations

Study Contact

Shari Goldfarb, MD
CONTACT
646-888-5080
goldfars@mskcc.org
Jeanne Carter, PhD
CONTACT
646-888-5076
carterj@mskcc.org

Principal Investigator

Shari Goldfarb, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Shari Goldfarb, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-20
Study Completion Date2029-06-20

Study Record Updates

Study Start Date2025-06-20
Study Completion Date2029-06-20

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • 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
  • Hormone Receptor Positive Malignant Neoplasm of Breast