UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting induced chemotherapy for breast cancer.
Title of the study (Brief title)	Study of Aprepitant / Palonosetron / Dexamethasone for nausea and vomiting
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 investigation the efficacy of Aprepitant/Palonosetron/Dexamethasone for nausea and vomiting induced AC/EC/FEC for adjuvant or neoadjuvant chemotherapy breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The proportion of patients with no emetic episodes and no rescue medication (Complete Response (CR)) for 5 days
Key secondary outcomes	Complete Control (CC) rate: defined as no emetic episodes, no rescue medication use, and no more than mild nausea for 5 days. Time to Treatment Failure: time to first emetic episode or time to administration of rescue therapy, whichever occurred first

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We use three anti emesis drugs (Aprepitant/Palonosetron/Dexamethasone) for this trial. The treatment schedule of 1) Aprepitant is oral administrated 125mg before administration of 1 hour~1 hour 30min for chemotherapy. And oral administrated 80mg at after breakfast on day 2, 3. 2) Palonosetron is intravenous administrated slowly 30 seconds or more for 0.75mg before administration of chemotherapy. 3) Dexamethasone is intravenous administrated 9.9mg before administration of chemotherapy. And oral administrated 4mg at after breakfast and dinner on day 2-4.
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	1) Histological confirmation of breast Cancer. 2) aged 20 years or more. 3) The following treatment is planned. Cyclophosphamide >= 500mg/m2 Doxorubicin >= 50mg/m2 Epirubicin >= 60mg/m2 4) adequate oran function, defined as WBC >= 3000/mm3 and/or Neu >=1,500/mm3 ,AST < 5.0xULN IU/L , ALT < 5.0xULN IU/L 5) performance status (PS) 0-2 6) written informed consent from the patients.
Key exclusion criteria	The exclusion criteria were as follows; patients were not eligible for this study if 1) Advanced or Recurrent breast Cancer. 2) child-pugh score > 9 3) they had undergone treatment with high emetic risk and moderate emetic risk chemotherapy by Japan society of clinical oncology prior to this study 4) they had undergone treatment with clarithromycin, ketoconazole, itraconazole within 7 days 5) they had undergone treatment with barbiturate, rifampicin, phenytoin, carbamazepine within 4 weeks. 6) they took warfarin. 7) they took oral contraceptive. 8) they had deep venous thrombosis 9) they had ascites or pleural effusion needs paracentesis treatment. 10) they had serious complication. (intestinal paralysis, lung fibrosis, diabetes mellitus, heart failure, myocardial infarction, angina pectoris, renal failure, psychiatric disorder, cerebrovascular accident, active gastric ulcer, active duodenal ulcer. 11) they had an associated symptom (ex infectious disease) patient who can not administer dexamethasone for 4 days. 12) they had a brain metastasis or suspected case. 13) they were operated within 28 day before entry 14) they operated radiation therapy 15) they except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Target sample size	55

Research contact person
Name of lead principal investigator	Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Breast Medical Oncology
Address	818 Ina-machi oaza komuro, kita-adachi-gun, Saitama, 362-0806, Japan
TEL	048-722-1111
Email

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' MammoClinic)
Address	3F Captal building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 07 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2012 Year 08 Month 01 Day
Date of closure to data entry	2012 Year 08 Month 01 Day
Date trial data considered complete	2012 Year 10 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 08 Month 10 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004841