Breast cancer
Conditions
Interventions
We use three anti emesis drugs (Palonosetron/Dexamethasone/Olanzapine) for this trial. The treatment schedule of 1) Palonosetron is intravenous administrated slowly 30 seconds or more for 0.75mg be
Sponsors
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histological confirmation of breast Cancer. 2) age 20 years or more patients. 3) The following treatment is planned. A) Cyclophosphamide >= 500mg/m2 B) Doxorubicin >= 50mg/m2 C) Epirubicin >= 60mg/m2 4) adequate organ function, defined as WBC >= 3000/mm3 and/or Neu >= 1500/mm3 ,AST < 5.0xULN IU/L, ALT < 5.0xULN IU/L 5) performance status (PS) 0-2 6) written informed consent from the patients.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows; patients were not eligible for this study if 1)they were Advanced or Recurrent breast Cancer patients. 2) they had child-pugh score > 9 3) they had undergone treatment with high emetic risk and moderate emetic risk chemotherapy by Japan society of clinical oncology prior to this study 4) they had undergone treatment with clarithromycin, ketoconazole, itraconazole within 7 days. 5) they had undergone treatment with barbiturate, rifampicin, phenytoin, carbamazepine within 4 weeks. 6) they took warfarin. 7) they took oral contraceptive. 8) they had deep venous thrombosis 9) they had ascites or pleural effusion needs paracentesis treatment. 10) they had serious complication. (intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer. 11) they had diabetes mellitus or past history of diabetes mellitus. 12) they had an associated symptom (ex infectious disease) patient who can not administer dexamethasone for 5 days. 13) they had a brain metastasis or suspected case. 14) they had hypersensitivity for Palonosetron or Dexamethason or Olanzapine. 15) they operated radiation therapy 16) they except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with no emetic episodes and no rescue medication (Complete Response(CR)) for 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Control (CC) rate: defined as no emetic episodes, no rescue medication use, and no more than mild nausea for 5 days. Time to Treatment Failure: time to first emetic episode or time to administration of rescue therapy, whichever occurred first | — |
Countries
Japan
Contacts
Public ContactToshihiro Kai
Saitama Breast Cancer Clinical Study Group (SBCCSG) Secretariat Division (Shintoshin Ladies' MammoClinic)
Outcome results
None listed