UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer
Title of the study (Brief title)	EC followed by ABI neoadjuvant chemotherapy for node positive breast cancer (Phase II Trial)
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the efficacy and safety of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Primary endpoint is to evaluate the pathological CR rate.
Key secondary outcomes	Secondary endpoint is to evaluate the Clinical response rate, pathological response rate,

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	EC(Epi-ADM 90mg/m2 and Cyclophosphamide 600mg/m2) is administered. One course is consisted by 3 weeks and repeated to 4 courses. After administrated 4 courses of EC, ABI 260mg/m2 is administered. One course is consisted by 3 weeks and repeated to 4 courses.
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	70 years-old >=
Gender	Female
Key inclusion criteria	1) Histologically breast cancer confirmed by needle biopsy. 2) Clinical stage T1-3, >=N1, M0 3) expected to radical cure by operation and neoadjuvant chemotherapy 4) has measurable region 5) Age 20 to 70 6) No prior surgery, radiation, chemotherapy and endcrinethrapy 7) Required baseline laboratory parameters (within 2 weeks before registration): Hb more than 9.0g/dl WBC more than 4000 /mm3 Neu more than 2000 / mm3 Plt more than 100,000/mm3 T-Bil less than 1.5 mg/dL AST(GOT) less than 2.5-times the upper limit of normal ALT(GPT) less than 2.5-times the upper limit of normal Cre less than 1.5 mg/dL cardiac electrogram : No clinically important abnormal finding 8)ECOG performance status is 0 to 1 9)Signed informed consent of the patient for the registration by their own volition.
Key exclusion criteria	1) History of sever hypersensitivity 2) Active other malignancies 3) Severe complications (infection, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure etc.) 4) has psychological illness which became a problem in practice 5) sever bone suppression, renal dysfunction, and liver dysfunction 6) sever pleural effusion or ascites fluid 7) has infection or fever which suspected of infection 8) pregnant or possibility of pregnant 9) Patients judged inappropriate by physicians
Target sample size	23

Research contact person
Name of lead principal investigator	Hiroyuki Kato
Organization	Dokkyo Medical University
Division name	Surgery 1
Address	880 Kitakobayashi, Mibu, Tochigi, Japan
TEL	0282-87-2157
Email	hkato@dokkyomed.ac.jp

Public contact
Name of contact person	Jun Ito
Organization	Dokkyo Medical University
Division name	Surgery 1
Address	880 Kitakobayashi, Mibu, Tochigi, Japan
TEL	0282-87-2157
Homepage URL
Email	j-ito@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	2013 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 01 Month 23 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011543