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

Inclusion Criteria:

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)

Exclusion Criteria:

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
Patients who have received live attenuated vaccines within 1 week of start of everolimus and during the study; patient should also avoid close contact with others who have received live attenuated vaccines; examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a typhoid vaccines
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Pregnant or nursing (lactating) women

Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following:

Use of oral, injected or implanted hormonal methods of contraception or
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository
Total abstinence or
Male/female sterilization Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential