A Study of Revaree Plus in People With Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 4

Conditions

Stage III Breast Carcinoma

Stage 0 Breast Carcinoma

Breast Cancer

Hormone-receptor-positive Breast Cancer

Stage II Breast Carcinoma

Stage II Breast Cancer

Stage I Breast Cancer

Hormone Receptor Positive Malignant Neoplasm of Breast

Stage III Breast Cancer

Hormone Receptor Positive Breast Carcinoma

Stage 0 Breast Cancer

Treatments

Drug: Revaree Plus

Study type

Interventional

Funder types

Other

Identifiers

NCT07042581

24-374

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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