Metastatic or recurrent breast cancer
Conditions
Interventions
Everolimus treatment
dental oral management
Sponsors
Oral Care-BC executive committee
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Female patient with a histological diagnosis of breast cancer. 2)Inoperable metastatic breast cancer, or metastatic progression/recurrent breast cancer after surgical operation. 3) Patient confirmed histologically to have ER-positive breast cancer. 4)Postmenopause 5)Any of the below conditions indicating resistance to aromatase inhibitor ; a)Recurrent breast cancer ; Recurrence during adjuvant therapy of aromatase inhibitor, or after the therapy within 12 months or below. b)Advanced breast cancer ; Progression during the treatment using aromatase inhibitor, or after the treatment within a month or below. 6)Any number of chemotherapy (anti-neoplastic drugs) are allowed since diagnosis of metastatic or recurrent breast cancer. 7) Aged >=20 years 8)ECOG Performance Status: 0 or 1 9)Previous treatment (including adjuvant therapy) satisfies all of below. a)Hormone therapy: At least 7 days have elapsed from last day of hormone therapy before the beginning of this protocol therapy. b)Radiation therapy: At least 14 days have elapsed from last day of irradiation before the beginning of this protocol therapy. 10)Organ function (within 4 weeks before enrollment) a)ANC >=1,500/mm3, or WBC >=3,000/mm3 b)Platelet count >=100,000/mm3 c)Total bilirubin <=2.5 times of ULN d)AST(GOT) and ALT(GPT) <=2.5 times of ULN e)Serum creatinine <=1.5 times of ULN (Upper limit of normal) 11)Others, Cardiac function 12)Written Informed Consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of stomatitis in over Grade 1 after everolimus treatment (evaluated by a cancer treatment doctor) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public Health Research Foundation Comprehensive Support Project for Oncology Research
Outcome results
None listed