Breast CancerPhase 4NCT07042581
A Study of Revaree Plus in People With Breast Cancer
A Phase 4 study testing Revaree Plus in people with Breast Cancer and Stage 0 Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer
- What is being tested?
- Revaree Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jun 2025to 20 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only)
Commack, New York, 11725
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Shari Goldfarb, MD, 646-888-5080
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Shari Goldfarb, MD, 646-888-5080
About this study
Official title: Evaluation of Revaree Plus in Women With Breast Cancer
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, Stage 0 Breast Carcinoma
- Being tested
- Revaree Plus
- 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
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revaree PlusDrug
Revaree Plus is a hyaluronic acid vaginal suppository
| Study group | Role | What they receive |
|---|---|---|
| Hormone-receptor positive breast cancer participants | Experimental | Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer Receives: Drug: Revaree Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Assessment Scale from baseline to 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start20 Jun 2025
- Primary completion20 Jun 2029 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Goldfarb, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042581
- Sponsor's protocol ID
- 24-374
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Revaree Plus in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07042581
- Acronym / sponsor ID
- 24-374
- Conditions
- Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage 0 Breast Carcinoma
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Jun 2029 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormone-receptor positive breast cancer participants | Experimental | Drug: Revaree PlusParticipants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revaree PlusRevaree Plus is a hyaluronic acid vaginal suppository | Drug | Hormone-receptor positive breast cancer participants |
Primary outcome
Change in Vaginal Assessment Scale from baseline to 8 weeks
Time frame: 8 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari Goldfarb, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Revaree Plus in people with Breast Cancer and Stage 0 Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shari Goldfarb, MD (646-888-5080, goldfars@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaginal Assessment Scale from baseline to 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.