Breast Cancer
Conditions
Interventions
Aprepitant (day 1: 125 mg, days 2-3:80mg) + dexamethasone (day 1: 9.9 mg) + granisetron (day 1: 40(microgram)/kg)
Aprepitant (day 1: 125 mg, days 2-3:80mg) + dexamethasone (day 1: 9.9 mg) + palonosetr
Sponsors
Juntendo Clinical Research Support Center
Juntendo Nerima Hospital,Juntendo Urayasu Hospital,Juntendo Shizuoka Hospital,Shizuoka General Hospital,Mie University Hospital,Sapporo Medical University Hospital,Toho University Omori Medical Center,Ome Municipal General Hospital,Nippon Medical School Musashi Kosugi Hospital,Tottori University Hospital,Kanto Central Hospital of the Mutual Aid Association of Public School Teachers, Tokyo Medical University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients aged >= 20 years old and <= 75 years old (at the time informed consent was obtained) 2) Female patients 3) Patients with primary breast cancer of stages I to III who are scheduled to receive AC therapy 4) Patients with an ECOG Performance Status of 0 - 1 5) Patients who can correctly fill in a symptom diary 6) Patients who meet the following standard values in general clinical tests: -White blood cells >= 3,000 /mm**3, and neutrophils >= 1,500 /mm**3 -Blood platelet count>= 100,000 /mm**3 -AST (GOT) and ALT (GPT) <= 2.5 times the high end of the normal range at the facility -Total bilirubin <= 1.5 times the high end of the normal range at the facility -Creatinine <= 1.5 times the high end of the normal range at the facility 7) Patients with normal cardiac function: -ECG within the normal range, no symptoms, and no abnormality requiring treatment - Cardiac function has been determinined to be normal by Interview, Echocardiography,Chest X-ray, BNP etc
Exclusion criteria
Exclusion criteria: 1) Patients with a history of administration of moderate to high emetogenic chemotherapy 2) Patients receiving administration of an antiemetic drug (5-HT3 receptor antagonist, phenothiazine, butyrophenone, benzamide, or dopamine receptor antagonist) 3) Patients who received administration of a benzodiazepine or narcotic formulation within 48 hours before commencement of AC therapy 4) Patients who received systemic corticosteroid therapy within 72 hours before commencement of AC therapy 5) Patients with a history of gastrointestinal tract surgery (excluding appendectomy) 6) Patients who received or are scheduled to receive radiation therapy for the abdominal region (diaphragm or lower) or pelvis for a period from 6 days before commencement of AC therapy until Day 6 of AC therapy 7) Patients who had vomiting or dry vomiting within 24 hours before commencement of AC therapy 8) Patients with active multiple cancer (synchronous multiple cancer or metachronous multiple cancer with a disease-free interval of 5 years or less) 9) Patients with a symptomatic cerebral tumor (including a benign tumor) 10) Patients who received administration of the following drugs within 7 days before commencement of AC therapy: clarithromycin, erythromycin, ketoconazole, itraconazole, and digoxin 11) Patients who received administration of the following drugs within 4 weeks before commencement of AC therapy: barbiturate drug, rifampicin, phenytoin, and carbamazepine 12) Pregnant or lactating patients, patients who may be pregnant, patients hoping to become pregnant during the study period, and patients taking an oral contraceptive 13) Patients who have coexisting diseases, such as systemic infection, hepatitis, and uncontrollable diabetes, in whom dexamethasone sodium phosphate cannot be administered 14) Patients with a history of hypersensitivity to granisetron, palonosetron, aprepitant or dexamethasone 15) Other patients who are judged to be inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who showed complete response (no vomiting and no salvage treatment) during a period from 24 to 120 hours after AC therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)The proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 24 hours of AC therapy (2)The proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 120 hours of AC therapy (3)proportion of patients who showed no nausea / degree of nausea (4)QOL (5)Dietary intake (6)Adverse events | — |
Countries
Japan
Contacts
Public ContactMitsue Saito
Juntendo University Hospital Department of Breast Oncology
Outcome results
None listed