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Search / Trial NCT07042581

A Study of Revaree Plus in People With Breast Cancer

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jun 20, 2025

Trial Information

Current as of July 09, 2025

Recruiting

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

ClinConnect Summary

This clinical trial is studying a treatment called Revaree Plus to see if it can help improve vaginal health in women who are experiencing symptoms like vaginal dryness or pain during breast cancer treatment. These symptoms often happen because certain breast cancer treatments lower estrogen levels, which can cause discomfort. The study is open to women aged 65 to 74 who have hormone-receptor-positive breast cancer at stages 0 to 3, have finished chemotherapy or radiation, and are currently taking medications like aromatase inhibitors or tamoxifen to maintain their treatment. Participants should be experiencing bothersome vaginal symptoms related to low estrogen.

If you join the study, you will be asked to complete questionnaires about your symptoms and use Revaree Plus to see if it helps improve your comfort. To be eligible, you need to have no signs of active cancer, not be using hormone replacement therapy or other vaginal treatments, and be able to understand and agree to the study instructions. The study is currently recruiting participants, and anyone considering joining will need to give informed consent, which means you agree to take part after learning about the study’s purpose and what it involves. This research aims to find better ways to support women’s quality of life during breast cancer treatment by addressing these common but often overlooked symptoms.

Gender

FEMALE

Eligibility criteria

  • 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

About Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.

Locations

New York, New York, United States

Montvale, New Jersey, United States

Uniondale, New York, United States

Harrison, New York, United States

Basking Ridge, New Jersey, United States

Middletown, New Jersey, United States

Commack, New York, United States

Patients applied

0 patients applied

Trial Officials

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported