Clinical trial · Interventional
A Study of Revaree Plus in People With Breast Cancer
Evaluation of Revaree Plus in Women With Breast Cancer
NCT07042581CI-TRIAL-00102630recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hormone-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Hormone Receptor Positive Breast Carcinoma | Hormone Receptor-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hormone Receptor Positive Malignant Neoplasm of Breast | — | UNRESOLVED | — |
| Stage 0 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage 0 Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Carcinoma | Breast Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Revaree Plus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hormone-receptor positive breast cancer participants
- description
- Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer
- interventionNames
- Drug: Revaree Plus
Primary outcomes (1)
- measure
- Change in Vaginal Assessment Scale from baseline to 8 weeks
- timeFrame
- 8 weeks
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.