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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 20, 2014
Last updated: September 10, 2015
Last verified: September 2015

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

Condition Intervention Phase
Advanced Breast Cancer
Drug: Dexamethasone based mouth
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of Grade ≥ 2 stomatitis at 2 months [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Report the incidence of Grade ≥ 2 stomatitis at 2 months, in patients using prophylactic steroid mouthwash alcohol-free dexamethasone 0.5mg/5ml and compare to BOLERO-2 historical controls, in postmenopausal women with advanced or metastatic hormone receptor positive breast cancer.

Secondary Outcome Measures:
  • Average time to resolution [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Average number of times per day mouthwash regimen performed at 2-months (56 days). Dose intensity of everolimus and exemestane at 2-months (56 days). Incidence of all grades stomatitis at 2-months (56 days). Time to resolution (total # days) from diagnosis of stomatitis (Gr>2) to resolution (Gr≤ 1).

Estimated Enrollment: 97
Study Start Date: June 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone based mouthwash
Dexamethasone based mouthwash in postmenopausal women with advanced or metastatic hormone receptor positive breast cancer being treated with everolimus plus exemestane
Drug: Dexamethasone based mouth
Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02069093

Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center Comp Cancer Ctr (5) Withdrawn
Birmingham, Alabama, United States, 35294
United States, Arkansas
Highlands Oncology Group Highlands Oncology Group (22) Recruiting
Fayetteville, Arkansas, United States, 72703
Contact    +1 479 872 8130      
Principal Investigator: Joseph Thaddeus Beck         
United States, California
Kaiser Permanente Medical Group Kaiser Permanente - Moanalua Recruiting
Anaheim, California, United States, 92807
Contact    808-432-8587      
Principal Investigator: Jennifer Carney         
Comprehensive Blood and Cancer Center Dept. of CBCC (2) Withdrawn
Bakersfield, California, United States, 93309
Los Angeles Hematology/Oncology Medical Group Recruiting
Los Angeles, California, United States, 90017
Contact    213-977-1214      
Principal Investigator: Lasika Seneviratne         
University of California at Los Angeles UCLA and TRIO Network Recruiting
Los Angeles, California, United States, 90095-6956
Contact    310-267-5964      
Principal Investigator: John A. Glaspy         
North Valley Hematology/Oncology SC Withdrawn
Northridge, California, United States, 91328
University of California Irvine UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact    714-456-5053      
Principal Investigator: Chaitali Nangia         
California Pacific Medical Center SC Recruiting
San Francisco, California, United States, 94115
Contact    415-600-1654      
Principal Investigator: Wei Wang         
University of California San Francisco UCSF Medical Center Recruiting
San Francisco, California, United States, 94101
Contact    415-353-7428      
Principal Investigator: Hope S. Rugo         
United States, Colorado
Denver Health & Hospital Authority Onc Dept Withdrawn
Denver, Colorado, United States, 80204-4507
St. Mary's Cancer Center Regional Cancer Center Withdrawn
Grand Junction, Colorado, United States, 81502
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030-3940
Contact    860-679-3940      
Principal Investigator: Rajesh V. Lalla         
United States, Georgia
Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
Contact    770-400-6629      
Principal Investigator: Navneet Dhillon         
United States, Hawaii
OnCare Hawaii Recruiting
Aiea, Hawaii, United States, 96701
Contact    +1 808 487 7447      
Principal Investigator: Arnold K. N. Yee         
United States, Illinois
North Shore University Health System NorthShore University Recruiting
Evanston, Illinois, United States, 60201
Contact    847-570-2515      
Principal Investigator: Douglas E. Merkel         
Oncology Specialists, SC Onc Specialists Recruiting
Park Ridge, Illinois, United States, 60068-0736
Contact    847-268-8200      
Principal Investigator: Sigrun Hallmeyer         
United States, Kansas
University of Kansas Cancer Center Univ of Kansas Cancer Ctr (2) Withdrawn
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky SC-5 Withdrawn
Lexington, Kentucky, United States, 40536-0293
United States, Maryland
University of Maryland School of Medicine University of Maryland Recruiting
Baltimore, Maryland, United States, 21201-1559
Contact    410-706-7956      
Principal Investigator: Timothy Meiller         
Kaiser Permanente - Mid Atlantic Permanete Research Institut Kaiser Permanente Mid-Atlantic Recruiting
Rockville, Maryland, United States, 20850
Contact    240-632-4825      
Principal Investigator: Leon Hwang         
United States, Massachusetts
Lahey Clinic Dept of Lahey Clinic (4) Withdrawn
Burlington, Massachusetts, United States, 01805
Baystate Medical Center Withdrawn
Springfield, Massachusetts, United States, 00119
United States, Michigan
Karmanos Cancer Institute Karmanos Cancer Institute (2) Recruiting
Detroit, Michigan, United States, 48201
Contact    313-576-8914      
Principal Investigator: Sayeh Lavasani         
United States, Missouri
Saint Luke's Cancer Institute Cancer Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact    816-932-3300      
Principal Investigator: Timothy Pluard         
Mercy Medical Research Institute SC Withdrawn
Manchester, Missouri, United States, 63021
United States, New Hampshire
Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon Withdrawn
Bedford, New Hampshire, United States, 03110
United States, New Jersey
Regional Cancer Care Associates Cancer and Hematologic Disease Recruiting
Cherry Hill, New Jersey, United States, 08003
Contact    856-424-3311      
Principal Investigator: Priya Gor         
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2) Recruiting
Morristown, New Jersey, United States, 07962
Contact    +1 973 538 3593 ext.2338      
Principal Investigator: Steven Papish         
United States, Ohio
Case Western Reserve University School of Medicine Case Medical Center Withdrawn
Cleveland, Ohio, United States, 44106-5000
United States, Pennsylvania
Lancaster Cancer Center Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact    717-291-1313      
Principal Investigator: H. Peter DeGreen         
Drexel University College of Medicine Oncology Recruiting
Philadelphia, Pennsylvania, United States, 19102-1192
Contact    215-789-3609      
Principal Investigator: Kristine Ward         
University of Pittsburgh Cancer Institute Magee-Womens Hospital Withdrawn
Pittsburgh, Pennsylvania, United States, 15232
Abington Hematology Oncology Associates, Inc Abington Hem Onc Recruiting
Willow Grove, Pennsylvania, United States, 19090
Principal Investigator: Michael Seidman         
United States, South Carolina
M. Francisco Gonzalez, MD.PA Hematology Oncology Center Recruiting
Columbia, South Carolina, United States, 29203
Principal Investigator: M. Francisco Gonzalez         
Upstate Oncology Associates Upstate Oncology Assoc. (5) Recruiting
Greenville, South Carolina, United States, 29601
Contact    864-546-3699      
Principal Investigator: Stephen Dyar         
United States, Tennessee
Vanderbilt University Medical Center Medical Center (2) Recruiting
Nashville, Tennessee, United States, 37232
Contact    615-322-4967      
Principal Investigator: Brent N. Rexer         
United States, Texas
University of Texas Southwestern Medical Center UT Southwestern Withdrawn
Dallas, Texas, United States, 75390-8852
Texas Tech University Health Science Center Health Sciences Center Recruiting
El Paso, Texas, United States, 79905
Contact    915-545-6618      
Principal Investigator: Zeina Nahleh         
Oncology Consultants Oncology Consultants, P.A. Recruiting
Houston, Texas, United States, 77024
Contact    713-827-9525      
Principal Investigator: Julio Peguero         
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2) Recruiting
Houston, Texas, United States, 77030-4009
Contact    713-563-0754      
Principal Investigator: Jennifer Litton         
United States, Virginia
Delta Oncology Associates Delta Hematology/Oncology Recruiting
Portsmouth, Virginia, United States, 23704
Principal Investigator: Lloyd A. Shabazz         
United States, Washington
Swedish Cancer Institute Swedish Cancer Institute (2) Withdrawn
Seattle, Washington, United States, 98104
Northwest Medical Specialties Northwest Medical - Puyallup Recruiting
Tacoma, Washington, United States, 98405
Contact    253-620-4234      
Principal Investigator: Sibel Blau         
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT02069093     History of Changes
Other Study ID Numbers: CRAD001JUS226
Study First Received: February 20, 2014
Last Updated: September 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Mouth Diseases
Neoplasms by Site
Skin Diseases
Stomatognathic Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses processed this record on October 06, 2015