Breast Cancer Clinical Trial

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

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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

Exclusion criteria:

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:

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).

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

92

Study ID:

NCT02069093

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 23 Locations for this study

See Locations Near You

Highlands Oncology Group Highlands Oncology Group (22)
Fayetteville Arkansas, 72703, United States
Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C
Anaheim California, 92807, United States
Los Angeles Hematology/Oncology Medical Group
Los Angeles California, 90017, United States
University of California at Los Angeles UCLA and TRIO Network
Los Angeles California, 90095, United States
University of California Irvine UC Irvine Medical Center
Orange California, 92868, United States
University of California San Francisco UCSF Medical Center
San Francisco California, 94101, United States
California Pacific Medical Center SC
San Francisco California, 94115, United States
University of Connecticut Health Center
Farmington Connecticut, 06030, United States
Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
OnCare Hawaii
Aiea Hawaii, 96701, United States
North Shore University Health System NorthShore University
Evanston Illinois, 60201, United States
Oncology Specialists, SC Onc Specialists
Park Ridge Illinois, 60068, United States
University of Maryland School of Medicine University of Maryland
Baltimore Maryland, 21201, United States
Kaiser Permanente - Mid Atlantic Permanete Research Institut Kaiser Permanente Mid-Atlantic
Rockville Maryland, 20850, United States
Karmanos Cancer Institute Karmanos Cancer Institute (2)
Detroit Michigan, 48201, United States
Saint Luke's Hospital/Marion Bloch Neuroscience Institute Cancer Institute
Kansas City Missouri, 64111, United States
Regional Cancer Care Associates Cancer and Hematologic Disease
Cherry Hill New Jersey, 08003, United States
Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)
Morristown New Jersey, 07962, United States
M. Francisco Gonzalez, MD.PA Hematology Oncology Center
Columbia South Carolina, 29203, United States
Oncology Consultants Oncology Consultants, P.A.
Houston Texas, 77024, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)
Houston Texas, 77030, United States
Delta Oncology Associates Delta Hematology/Oncology
Portsmouth Virginia, 23704, United States
Northwest Medical Specialties Northwest Medical - Puyallup
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

92

Study ID:

NCT02069093

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.