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Advanced Breast CancerPhase 2NCT02069093

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 testing Dexamethasone based mouthwash, Everolimus and Exemestane in people with Advanced Breast Cancer, run by Novartis Pharmaceuticals at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Dexamethasone based mouthwash, Everolimus and Exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
23 sitesUnited States
Study dates
May 2014to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women > 18 years of age with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy
  • Histological or cytological confirmation of hormone-receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer
  • 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
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  • 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
  • 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
  • Patient must start everolimus 10mg plus exemestane 25mg treatment on Cycle 1 Day 1 of trial
  • ECOG Performance status ≤ 2
  • Adequate renal function: serum creatinine ≤ 1.5x ULN;
  • 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
  • Signed informed consent obtained prior to any screening procedure

Who cannot join

  • Patients currently receiving anticancer therapies (except biphosphonate, denosumab);
  • Patients who currently have stomatitis/oral mucositis/mouth ulcers;
  • Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);
  • Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus;
  • 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;
  • Patients who have any severe and/or uncontrolled medical conditions such as:
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  • 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;
  • Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;
  • Known history of 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, BCG, yellow fever, varicella and TY21a typhoid vaccines;
  • 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;
  • 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;
  • 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).

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

United States23 sites

  • OnCare Hawaii

    ‘Aiea, Hawaii, 96701

  • Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

    Anaheim, California, 92807

  • University of Maryland School of Medicine University of Maryland

    Baltimore, Maryland, 21201-1559

  • Regional Cancer Care Associates Cancer and Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • M. Francisco Gonzalez, MD.PA Hematology Oncology Center

    Columbia, South Carolina, 29203

  • Karmanos Cancer Institute Karmanos Cancer Institute (2)

    Detroit, Michigan, 48201

  • North Shore University Health System NorthShore University

    Evanston, Illinois, 60201

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030-3940

  • Highlands Oncology Group Highlands Oncology Group (22)

    Fayetteville, Arkansas, 72703

  • Oncology Consultants Oncology Consultants, P.A.

    Houston, Texas, 77024

  • University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)

    Houston, Texas, 77030-4009

  • Saint Luke's Hospital/Marion Bloch Neuroscience Institute Cancer Institute

    Kansas City, Missouri, 64111

  • Los Angeles Hematology/Oncology Medical Group

    Los Angeles, California, 90017

  • University of California at Los Angeles UCLA and TRIO Network

    Los Angeles, California, 90095-6956

  • Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)

    Morristown, New Jersey, 07962

  • Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • University of California Irvine UC Irvine Medical Center

    Orange, California, 92868

  • Oncology Specialists, SC Onc Specialists

    Park Ridge, Illinois, 60068-0736

  • Delta Oncology Associates Delta Hematology/Oncology

    Portsmouth, Virginia, 23704

  • Kaiser Permanente - Mid Atlantic Permanete Research Institut Kaiser Permanente Mid-Atlantic

    Rockville, Maryland, 20850

  • University of California San Francisco UCSF Medical Center

    San Francisco, California, 94101

  • California Pacific Medical Center SC

    San Francisco, California, 94115

  • Northwest Medical Specialties Northwest Medical - Puyallup

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase II, Single Arm Study of the Use of Steroid-based Mouthwash to Prevent Stomatitis in Postmenopausal Women With Advanced or Metastatic Hormone Receptor Positive Breast Cancer Being Treated With Everolimus Plus Exemestane

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

Being tested
Dexamethasone based mouthwash, Everolimus, Exemestane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone based mouthwashDrug

    Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.

  • EverolimusDrug

    Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations.

  • ExemestaneDrug

    Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.

Study groups in NCT02069093
Study groupRoleWhat they receive
Dexamethasone based mouthwashExperimentalParticipants 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.
Receives: Drug: Dexamethasone based mouthwash; Drug: Everolimus; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Stomatitis Grade ≥ 2

    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.

    Measured: 56 days

Secondary outcomes (5)

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

    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.

    Measured: 56 days

  2. Median Number of Mouthwashes Per Day

    The median number of mouthwashes per day was assessed.

    Measured: 56 days

  3. Number of Participants With All Grades of Stomatitis

    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.

    Measured: 56 days

  4. Dose Intensity of Everolimus and Exemestane

    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.

    Measured: 56 days

  5. Blood Concentration of Everolimus and Exemestane

    Blood samples were collected and analyzed.

    Measured: 28 days (pre-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02069093
Sponsor's protocol ID
CRAD001JUS226
Status last verified
Dec 2016
First submitted
20 Feb 2014
Last updated
13 Feb 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 32043762

  • 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.

    PubMed 28314691

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone based mouthwash, Everolimus and Exemestane in people with Advanced Breast Cancer, run by Novartis Pharmaceuticals at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Stomatitis Grade ≥ 2 (time frame: 56 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02069093, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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