UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter double-blind randomized comparative parallel study with concomitant therapy of 3 drugs, aprepitant + dexamethasone+palonosetron or aprepitant + dexamethasone+ granisetron, for prevention of nausea/vomiting in breast cancer patients receiving AC therapy
Title of the study (Brief title)	Comparison of concomitant therapy with 3 drugs, aprepitant + dexamethasone+5HT3ra (palonosetron or granisetron), for prevention of nausea/vomiting in breast cancer patients receiving AC therapy;Trial for Antiemetic Triplet Therapy(TTT)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of new antiemetic drugs (palonosetron) in AC therapy for breast cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	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
Key secondary outcomes	(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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aprepitant (day 1: 125 mg, days 2-3:80mg) + dexamethasone (day 1: 9.9 mg) + granisetron (day 1: 40(microgram)/kg)
Interventions/Control_2	Aprepitant (day 1: 125 mg, days 2-3:80mg) + dexamethasone (day 1: 9.9 mg) + palonosetron (day 1: 0.75 mg)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key 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
Key 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.
Target sample size	660

Research contact person
Name of lead principal investigator	Mitsue Saito
Organization	Juntendo University Hospital
Division name	Department of Breast Oncology
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421
TEL	03-3813-3111
Email	mitsue@juntendo.ac.jp

Public contact
Name of contact person	Mitsue Saito
Organization	Juntendo University Hospital
Division name	Department of Breast Oncology
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421
TEL	03-3813-3111
Homepage URL
Email	mitsue@juntendo.ac.jp

Sponsor
Institute	Juntendo Clinical Research Support Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Non-Profit Organization: Japan Clinical Research Support Unit
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	順天堂大学医学部附属順天堂医院（東京）,順天堂大学附属練馬病院（東京）,順天堂大学附属浦安病院（千葉）,順天堂大学附属静岡病院（静岡）,静岡県立総合病院（静岡）,三重大学医学部附属病院（三重）,札幌医科大学附属病院（北海道）,東邦大学医療センター大森病院（東京）,青梅市立総合病院（東京）,日本医科大学武蔵小杉病院（神奈川）,鳥取大学医学部附属病院（鳥取）,関東中央病院（東京）,東京医科大学病院（東京）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 02 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 08 Month 30 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2015 Year 10 Month 31 Day
Date of closure to data entry	2015 Year 12 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 24 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 02 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009285