Unique ID issued by UMIN | UMIN000010423 |
---|---|
Receipt number | R000012188 |
Scientific Title | SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study |
Date of disclosure of the study information | 2013/04/04 |
Last modified on | 2017/07/30 20:55:06 |
SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study
SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study
SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study
SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study
Japan |
Breast Cancer
Breast surgery |
Malignancy
YES
To investigate the association between the genetic polymorphism and the efficacy of the triplet antiemetics in breast cancer patients received highly emetogenic chemotherapy.
Efficacy
Exploratory
Pragmatic
Not applicable
Percentage of patients with complete response (defined as "no-emesis", and "no-rescue medication") in the overall phase (0-120 h after chemotherapy)
Observational
20 | years-old | <= |
Not applicable |
Female
1) Breast cancer patients
2) Over 20 years old
3) Patients who receive the first cycle of chemotherapy with AC (doxorubicin >= 50 mg/m2, cyclophosphamide >=500 mg/m2), EC (epirubicin >=75 mg/m2, cyclophosphamide >=500 mg/m2), or FEC (5-FU >=500 mg/m2, epirubicin >=75 mg/m2, cyclophosphamide >=500 mg/m2) regimen.
4) Informed consent by the document.
5) WBC >=3,000 /mm3, PLT >=75,000 /mm3 Hgb >=8.0 g/dL
6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 x upper limit of normal. Blood bilirubin <= 1.5 x upper limit of normal.
7) Creatinine <= 1.5 x upper limit of normal.
1) Patients with some factors such as brain tumor, brain metastasis causing nausea and vomiting.
2) Received a CYP3A4 inducer (such as phenobarbital, phenytoin, carbamazepine, rifampicin and efavirenz) or inhibitor (such as clarithromycin, erythromycin, voriconazole, itraconazole and ritonavir) within 7 days before administration of anticancer drug.
3) Received a CYP2D6 inhibitor (terbinafine, fluvoxamine, paroxetine, escitalopram, duloxetine, cimetidine, quinidine) within 7 days before administration of anticancer drug.
4) Received a 5-HT3 receptor antagonist, D2 blocker or NK1 receptor antagonist within 7 days before administration of anticancer drug.
5) Received a radiation therapy within 14 days before administration of anticancer drug.
6) Hypersensitivity to therapeutic agent.
7) Patients who had been treated with one moderate of high emetogenic antitumour drug according to the 2012 National Comprehensive Cancer Network Clinical Practice Guidelines.
8) Pregnant
9) Unstable glycemic control.
10) Patients judged ineligible by researcher.
100
1st name | |
Middle name | |
Last name | Kazuya Ooi |
Suzuka University of Medical Science
Faculty of Pharmaceutical Sciences
3500-3, Minamitamagaki-cho, Suzuka, 513-8670, Mie
059-340-0571
zooi@suzuka-u.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Yokoyama |
Suzuka University of Medical Science
Faculty of Pharmaceutical Sciences
3500-3, Minamitamagaki-cho, Suzuka, 513-8670, Mie
059-340-0762
s-yoko@umin.net
Laboratory of clinical pharmacology, Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science
Suzuka University of Medical Science
Self funding
Japan
NO
2013 | Year | 04 | Month | 04 | Day |
Published
Completed
2012 | Year | 04 | Month | 26 | Day |
2013 | Year | 04 | Month | 04 | Day |
Blood samples are collected from breast cancer patients who received AC, EC, or FEC combination regimen. Relationship between genetic polymorphisms and antiemetic effect are assessed.
2013 | Year | 04 | Month | 04 | Day |
2017 | Year | 07 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012188