Who is sponsoring NCT02015559?

NCT02015559 is sponsored by Jonsson Comprehensive Cancer Center.

What drugs are being tested in NCT02015559?

Interventions in NCT02015559: mucoadhesive oral wound rinse, laboratory biomarker analysis.

What condition does NCT02015559 study?

NCT02015559 studies Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Oral Complications, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer.

Is NCT02015559 still recruiting?

NCT02015559 is currently completed. Last updated 21 September 2020.

Last reviewed 2020-09-21 · How we verify

NCT02015559

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 21 September 2020

What this trial tests

Phase 2 trial testing mucoadhesive oral wound rinse in Estrogen Receptor-positive Breast Cancer in 61 participants. Completed in 30 November 2018.

Timeline

8 October 2014

Primary endpoint
30 November 2018

30 November 2018

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	61
Start date	8 October 2014
Primary completion	30 November 2018
Estimated completion	30 November 2018
Sites	1 location across United States

Drugs / interventions tested

mucoadhesive oral wound rinse — full drug profile →
laboratory biomarker analysis — full drug profile →

Conditions studied

Estrogen Receptor-positive Breast Cancer — all drugs for Estrogen Receptor-positive Breast Cancer →
HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →
Oral Complications — all drugs for Oral Complications →
Progesterone Receptor-positive Breast Cancer — all drugs for Progesterone Receptor-positive Breast Cancer →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, female only, with Estrogen Receptor-positive Breast Cancer or HER2-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Meta-analysis of stomatitis in clinical studies of everolimus: incidence and relationship with efficacy.
Rugo HS, Hortobagyi GN, Yao J, Pavel M, et al · · 2016 · cited 62× · PMID 26759276 · DOI 10.1093/annonc/mdv595
Phase II randomized trial of a non-steroidal mouth wash for prevention and treatment of stomatitis in women with hormone receptor positive breast cancer treated with everolimus.
Peddi PF, Tetef M, Coluzzi P, Arzoo KK, et al · · 2020 · cited 1× · PMID 33299473 · DOI 10.1177/1758835920967259

Verify or expand the search:

Other recruiting trials for Estrogen Receptor-positive Breast Cancer

Currently open trials in the same condition.

NCT06439693 — The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer · Phase 2 · recruiting
NCT04597580 — Personalised Disease Monitoring in Metastatic Breast Cancer · active not recruiting
NCT02957968 — Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca · Phase 2 · active not recruiting
NCT01953588 — Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery · Phase 3 · active not recruiting

Other Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02015559 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
Last refreshed: 21 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02015559.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing