UMIN-CTR Clinical Trial

Basic information
Public title	Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Acronym	Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Scientific Title	Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Scientific Title:Acronym	Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the superiority of aprepitant therapy to Non-aprepitant therapy in dose intensity and improvement of prognosis in patients with breast cancer receiving EC/FEC or AC regimen as pre/post-operative adjuvant chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percent of patients with 85% or more in relative dose intensity of epirubicin or doxorubicin
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) Breast cancer patient (a) planned to have three cycles or more of EC/FEC or AC regimen as pre/post-operative chemotherapy, (b) received at least one cycle, (c) had no progressive recurrence or metastasis 2) Patient was received chemotherapy including 75 mg/m2 or more of epirubicin, and 60 mg/m2 or more of doxorubicin in initial cycle 3) Patient was treated with either (a) Non-aprepitant therapy - patient was treated with a 5HT3-receptor antagonist and dexamethasone from the first cycle through the last cycle between January 2008 and December 2012, or (b) Aprepitant therapy (b-I) patient was treated with a 5HT3-receptor antagonist, dexamethasone, and aprepitant from the first cycle of chemotherapy between December 2009 and December 2012, (b-II) patient was treated with a 5HT3-receptor antagonist, dexamethasone, and aprepitant on the way since the second cycle of chemotherapy between December 2009 and December 2012 4) Day and dosage of anticancer drugs and antiemetic drugs can be identified in clinical record 5) Patient had never received any cancer chemotherapy other than the above EC/FEC or AC regimen with/without prior taxane treatment
Key exclusion criteria	-
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahiro Nakayama
Organization	Osaka Medical Center for Cancer and Cardiovascular Disease
Division name	Department of breast and endocrine surgery
Zip code
Address	1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Takahiro Nakayama
Organization	Osaka Medical Center for Cancer and Cardiovascular Disease
Division name	Department of breast and endocrine surgery
Zip code
Address	1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan
TEL	06-6972-1181
Homepage URL
Email

Sponsor
Institute	KBCSG (Kinki Breast Cancer Study Group)
Institute
Department

Funding Source
Organization	The Supporting Center for Clinical Research and Education (SCCRE)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 09 Day
Date of IRB	2011 Year 07 Month 22 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The purpose of this study is to demonstrate the superiority of aprepitant therapy to Non-aprepitant therapy in dose intensity and improvement of prognosis (DFS, OS) in patients with breast cancer receiving EC/FEC or AC regimen as pre/post-operative adjuvant chemotherapy.

Management information
Registered date	2011 Year 09 Month 05 Day
Last modified on	2019 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007432