Evaluation of Oral Care in preventing Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated with Everolimus: Randomized Controlled Phase III Trial
- Conditions
- Metastatic or recurrent breast cancer
- Registration Number
- JPRN-UMIN000016109
- Lead Sponsor
- Oral Care-BC executive committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 200
Not provided
1)Toothless jaw 2)Occurrence of stomatitis within 1 month prior to randomization 3)Chemotherapy used within 1 month prior to randomization 4)Exemestane monotherapy used just before the randomization (this is not met, if this therapy has not been used for over 3 months before randomization) 5) Previous mTOR inhibitor treatment (everolimus, etc.) 6)Interstitial pneumonia or pulmonary fibrosis. 7)Treatment with drugs, which are known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes, within 5 days prior to randomization. The dugs are shown below ; rifabutin, rifampicin, clarithromycin, ketoconazole, voriconazole, ritonavir, telithromycin 8)HBs antigen positive, and HBc antibody and/or HBs antibody positive. 9)HCV infection, or a history of HCV infection. 10)History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation. 11)Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a disease-free period of less than 5 years prior to randomization). 12)HER2 overexpression (Her2/neu, Erb B2), and requirement of trastuzumab (herceptin) treatment. In other words, patients that satisfy any of the below conditions will be excluded. At either the primary lesion or the metastatic lesion: a)Strongly Positive (3+) by HER2 immunohistochemical (IHC) test. b)Positive (+) by FISH (fluorescence in situ hybridization). 13)Brain metastasis that requires intracranial hypertension or emergency irradiation of the brain. 14)Extensive liver metastasis, or lymphangitic lung metastasis with accompanying dyspnea. 15)Pleural effusion, ascites, or pericardial effusion that requires emergency treatment. 16)Active infectious disease. 17)Uncontrolled diabetes mellitus or diabetes currently receiving insulin therapy. 18)Study participation is difficult due to mental illness or psychiatric symptoms. 19)Unable to participate the trial by an investigator's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of stomatitis in over Grade 1 after everolimus treatment (evaluated by a cancer treatment doctor)
- Secondary Outcome Measures
Name Time Method Each incidence of stomatitis in over Grade 2, or over Grade 3, (evaluated by a cancer treatment doctor) Each incidence of stomatitis in over Grade 1, over Grade 2 or over Grade 3 (evaluated by a cancer treatment doctor) Time to first occurrence of stomatitis Duration of each Grade of stomatitis Each ratio of patients in suspension, or dose-reduction of everolimus treatment due to stomatitis Oral Assessment Guide (Revised)1 Health-related quality of life(HRQOL) Time to treatment failure (TTF)