UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer.
Title of the study (Brief title)	Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer.
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This is a phase II neoadjuvant study aimed to evaluate the effect and safety of EC followed by Abraxane as neoadjuvant therapy in operable breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	pathological complete response (pCR)
Key secondary outcomes

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 followed by Abraxane
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	75 years-old >=
Gender	Female
Key inclusion criteria	1)infiltrating primary breast cancer 2)T1-3, N0-2, M0, neoadjuvant setting, operable breast cancer 3)confirmed ER/PgR/HER2 4)20-75 years old, femal 5)measureble lesion(PECIST version 1.1) 6)previously untreated 7)performance status(PS) 0-1 8)maintained organs function: omit 9)informed concent
Key exclusion criteria	1)cardiac dysfunction 2)severe complication(uncontoroled DM, hypertension, renal failure, hepatic failure, severe infection, mental disorder) 3)pregnancy, lactation 4)double cancer 5)bilateral breast cancer 6)pulmonary fibrosis, interstitial pneumonia 7)allergy 8)neuropathy 9)HBs antigen positive
Target sample size	25

Research contact person
Name of lead principal investigator	Yutaka Yaqmamoto
Organization	Kawasaki Medical School
Division name	Breast Thyroid Surgery
Address	577, Matsushima Kurashiki Okayama
TEL	086-462-1111
Email	yamayou@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Yutaka Yamamoto
Organization	Kawasaki Medical School
Division name	Breast Thyroid Surgery
Address	577, Matsushima Kurashiki Okayama
TEL	086-462-1111
Homepage URL
Email	yamayou@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki medical school, Breast Thyroid Surgery
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	2014 Year 06 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 23 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2018 Year 11 Month 19 Day
Date of closure to data entry	2018 Year 11 Month 19 Day
Date trial data considered complete	2018 Year 11 Month 19 Day
Date analysis concluded	2018 Year 12 Month 19 Day

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

Management information
Registered date	2014 Year 06 Month 23 Day
Last modified on	2018 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016703