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

NCT02015559 | Completed Phase 2 DMC

• 3 other identifiers: 13-001676NCI-2013-02384TRIO-US B10
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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; Estrogen Receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of grades 1-4 stomatitis assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  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.

  Up to 7 days after completion of treatment

Secondary Outcomes (1)

• Rate of grade 3/4 stomatitis assessed using CTCAE version 4.03

  Up to 7 days after completion of treatment

Other Outcomes (1)

• Rate of everolimus dose adjustment or discontinuation related to stomatitis

  Up to 7 days after completion of treatment

Study Arms (2)

Arm I (mucoadhesive oral wound rinse)

EXPERIMENTAL

Patients receive mucoadhesive oral wound rinse PO as a gentle swish for 30-60 seconds 3-6 times daily beginning on day 1 of everolimus therapy and continuing for up to 6 months in the absence of unacceptable toxicity.

Drug: mucoadhesive oral wound rinse; Other: laboratory biomarker analysis

Arm II (no intervention)

NO INTERVENTION

Patients receive no intervention.

Interventions

mucoadhesive oral wound rinse DRUG

Given PO

Also known as: MuGard, oral mucoadhesive protectant rinse

Arm I (mucoadhesive oral wound rinse)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (mucoadhesive oral wound rinse)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic or locally recurrent unresectable breast cancer
• Histological or cytological confirmed ER and/or PR positivity
• Progression through at least one prior line of endocrine therapy
• Participant is scheduled to initiate treatment with everolimus combined with exemestane or another form of endocrine therapy
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Hemoglobin (Hgb) ≥\>= 8.0 g/dL
• International normalized ratio (INR) =\< 2
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 X upper limit of normal (ULN) (or =\< 5 X ULN if hepatic metastases are present)

You may not qualify if:

• Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer by local laboratory testing (immunohistochemistry \[IHC\] 3+ staining or fluorescent in situ hybridization \[FISH\] positive)
• Baseline presence of oral ulcers
• Prior treatment with everolimus or another mammalian target of rapamycin (mTOR) inhibitor (temsirolimus)
• Patients on warfarin (patients on injectable blood thinners, such as Lovenox, are able to continue those)
• Patients currently receiving chemotherapy or who have received chemotherapy less than 4 weeks of the start of everolimus (including chemotherapy, radiation therapy, antibody based therapy, etc.)
• Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
• Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) \> 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary
• Patients who have any severe and/or uncontrolled medical conditions such as:
• Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =\< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
• Symptomatic congestive heart failure of New York heart Association class III or IV
• Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B virus surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\])
• Known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide \[DLCO\] 50% or less of normal and oxygen \[O2\] saturation 88% or less at rest on room air)
• Active, bleeding diathesis
• Chronic treatment with corticosteroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed
• Known history of human immunodeficiency virus (HIV) seropositivity

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Translational Research in Oncology: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Parvin Peddi

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: October 8, 2014
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 21, 2020

Record last verified: 2019-05

Locations

US (1)