UMIN-CTR Clinical Trial

Public title

SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study

Acronym

SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study

Scientific Title

SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study

Scientific Title:Acronym

SPADE (Single nucleotide polymorphism associated with Palonosetron, Aprepitant and DExamethasone) study

Region

Japan

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To investigate the association between the genetic polymorphism and the efficacy of the triplet antiemetics in breast cancer patients received highly emetogenic chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Percentage of patients with complete response (defined as "no-emesis", and "no-rescue medication") in the overall phase (0-120 h after chemotherapy)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kazuya Ooi

Organization

Suzuka University of Medical Science

Division name

Faculty of Pharmaceutical Sciences

Zip code

Address

3500-3, Minamitamagaki-cho, Suzuka, 513-8670, Mie

TEL

059-340-0571

Email

zooi@suzuka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Yokoyama

Organization

Suzuka University of Medical Science

Division name

Faculty of Pharmaceutical Sciences

Zip code

Address

3500-3, Minamitamagaki-cho, Suzuka, 513-8670, Mie

TEL

059-340-0762

Homepage URL

Email

s-yoko@umin.net

Institute

Laboratory of clinical pharmacology, Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science

Institute

Department

Personal name

Organization

Suzuka University of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

04

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

04

Month

26

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

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.

Registered date

2013

Year

04

Month

04

Day

Last modified on

2017

Year

07

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012188