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NCT02069093 · ClinicalTrials.gov registry record · Phase 2

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
92
Enrollment target

NCT02069093: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT02069093 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02069093, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
92 participants
Enrollment target

Study Summary

Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Primary Outcome

The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.

Interventions

  • DRUG Exemestane
  • DRUG Everolimus
  • DRUG Dexamethasone based mouthwash

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2014-05
Est. Completion 2016-03
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT02069093 record still lists

NCT02069093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).

The record links to 0 conditions, and to 3 interventions - of which Exemestane is the first listed.

NCT02069093 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02069093 about?

NCT02069093 is a clinical study titled "Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer". Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer

What is the current status of trial NCT02069093?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2014-05. Estimated completion is 2016-03.

What interventions are being tested in trial NCT02069093?

The interventions under investigation include: Exemestane (DRUG), Everolimus (DRUG), Dexamethasone based mouthwash (DRUG).

Who is sponsoring clinical trial NCT02069093?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02069093's enrollment target sits among peer trials

92 767th of 2000 higher than 1,230 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 NCT02069093, the US trial registry maintained by the National Library of Medicine. NCT02069093 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.