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NCT02015559 · ClinicalTrials.gov registry record · Phase 2

Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus

A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.

Completed
Registry status
Phase 2
Development phase
61
Enrollment target

NCT02015559: Completed Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.

NCT02015559 is a Phase 2 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02015559, a Phase 2 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well mucoadhesive oral wound rinse works in preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed by surgery receiving everolimus. Mucoadhesive oral wound rinse may help prevent symptoms of stomatitis, or mouth sores, in patients receiving everolimus.

Primary Outcome

Will be estimated and the 95% confidence interval (CI) will also be obtained. Chi-square test will be used to compare the stomatitis rates between the two study arms.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG mucoadhesive oral wound rinse

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2014-10-08
Est. Completion 2018-11-30
Phase Phase 2
Jonsson Comprehensive Cancer Center

321 total trials

What the finished NCT02015559 record still lists

NCT02015559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.

NCT02015559 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02015559 about?

NCT02015559 is a clinical study titled "Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus". This randomized phase II trial studies how well mucoadhesive oral wound rinse works in preventing and treating stomatitis in patients with estrogen receptor (ER)- or progesterone receptor (PR)-positive metastatic or locally recurrent breast cancer that cannot be removed by surgery receiving everolim...

What is the current status of trial NCT02015559?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2014-10-08. Estimated completion is 2018-11-30.

What interventions are being tested in trial NCT02015559?

The interventions under investigation include: laboratory biomarker analysis (OTHER), mucoadhesive oral wound rinse (DRUG).

Who is sponsoring clinical trial NCT02015559?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02015559's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02015559, the US trial registry maintained by the National Library of Medicine. NCT02015559 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.