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NCT02069093 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-02-13

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Stomatitis Grade ≥ 2

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outcome · POSTED

Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less

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outcome · POSTED

Median Number of Mouthwashes Per Day

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outcome · POSTED

Number of Participants With All Grades of Stomatitis

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outcome · POSTED

Dose Intensity of Everolimus and Exemestane

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outcome · POSTED

Blood Concentration of Everolimus and Exemestane

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Adult women \> 18 years of age with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy 2. Histological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer 3. Postmenopausal women. Postmenopausal status is defined either by: * Age ≥ 55 years and one year or more of amenorrhea * Age \< 55 years and one year or more of amenorrhea, with an estradiol assay \< 20 pg/ml * Surgical menopause with bilateral oophorectomy * Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression 4. Patient has been assessed by treating physician to be appropriate candidate for everolimus plus exemestane therapy as treatment of advanced or metastatic breast cancer and plans to prescribe everolimus 10mg PO QD in combination with exemestane 25mg PO QD 5. Patient must start everolimus 10mg plus exemestane 25mg treatment on Cycle 1 Day 1 of trial 6. ECOG Performance status ≤ 2 7. Adequate renal function: serum creatinine ≤ 1.5x ULN; 8. Willingness to self-report level of oral pain using Visual Analog Scale (VAS) and the Normalcy Diet Scale (NDS) throughout each stomatitis event, as required in the patient diary. At baseline, patient's self-reported oral pain level, using VAS, must be 0 and the normalcy diet scale score should ≥ 60 9. Signed informed consent obtained prior to any screening procedure Exclusion criteria: 1. Patients currently receiving anticancer therapies (except biphosphonate, denosumab); 2. Patients who currently have stomatitis/oral mucositis/mouth ulcers; 3. Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus); 4. Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus; 5. Uncontrolled diabetes mellitus as defined by 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; 6. 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 (except for Hep B and Hep C positive patients) * Known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air) * active, bleeding diathesis; 7. Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed; 8. Known history of HIV seropositivity; 9. 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, BCG, yellow fever, varicella and TY21a typhoid vaccines; 10. Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for ≥3 years; 11. 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 or patient diaries; 12. Patients who are currently part of any clinical investigation or who has not had resolution of all acute toxic effects or prior anti-cancer therapy to NCI CTCAE version 4.03 Grade 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
    intervention Names
    1. Drug: Dexamethasone based mouthwash
    2. Drug: Everolimus
    3. Drug: Exemestane
    label
    Dexamethasone based mouthwash
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dexamethasone based mouthwash
    description
    Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
    name
    Dexamethasone based mouthwash
    type
    DRUG
  2. arm Group Labels
    1. Dexamethasone based mouthwash
    description
    Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations.
    name
    Everolimus
    type
    DRUG
  3. arm Group Labels
    1. Dexamethasone based mouthwash
    description
    Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.
    name
    Exemestane
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
PREVENTION
Enrollment
count
92
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With Stomatitis Grade ≥ 2
    time Frame
    56 days
secondary Outcomes
  1. description
    The number of days to achieve resolution of stomatitis from grade 2 or greater to grade 1 or less was assessed. 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.
    measure
    Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less
    time Frame
    56 days
  2. description
    The median number of mouthwashes per day was assessed.
    measure
    Median Number of Mouthwashes Per Day
    time Frame
    56 days
  3. description
    The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. 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.
    measure
    Number of Participants With All Grades of Stomatitis
    time Frame
    56 days
  4. description
    The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.
    measure
    Dose Intensity of Everolimus and Exemestane
    time Frame
    56 days
  5. description
    Blood samples were collected and analyzed.
    measure
    Blood Concentration of Everolimus and Exemestane
    time Frame
    28 days (pre-dose)
Full study description
brief 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
Source references
references
  1. citation
    Niikura N, Nakatukasa K, Amemiya T, Watanabe KI, Hata H, Kikawa Y, Taniike N, Yamanaka T, Mitsunaga S, Nakagami K, Adachi M, Kondo N, Shibuya Y, Hayashi N, Naito M, Kashiwabara K, Yamashita T, Umeda M, Mukai H, Ota Y. Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial. Oncologist. 2020 Feb;25(2):e223-e230. doi: 10.1634/theoncologist.2019-0382. Epub 2019 Oct 8.
    pmid
    32043762
    type
    DERIVED
  2. citation
    Rugo HS, Seneviratne L, Beck JT, Glaspy JA, Peguero JA, Pluard TJ, Dhillon N, Hwang LC, Nangia C, Mayer IA, Meiller TF, Chambers MS, Sweetman RW, Sabo JR, Litton JK. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. Lancet Oncol. 2017 May;18(5):654-662. doi: 10.1016/S1470-2045(17)30109-2. Epub 2017 Mar 15.
    pmid
    28314691
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        r to those in previous studies.</li><li> The was no observed difference in OS between the arms.</li></ul></div></li><li>The single-arm <a href="/clinicaltrials/NCT02069093">SWISH</a> trial (NCT02069093) assessed the efficacy of a dexamethasone oral solution (0.5 mg per 5 mL) in the prevention of stomatitis in women receiving exem
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        .</li><li> The was no observed difference in OS between the arms.</li></ul></div></li><li>The single-arm <a href="/clinicaltrials/NCT02069093">SWISH</a> trial (NCT02069093) assessed the efficacy of a dexamethasone oral solution (0.5 mg per 5 mL) in the prevention of stomatitis in women receiving exemestane plus everolimus.[<a hre
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      source title
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      source update dates
      1. context
        Updated: April 25, 2025
        datetime
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        display
        April 25, 2025

    Preserved source evidence · Not medical advice