UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II neoadjuvant trial of sequential nab-paclitaxel followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer
Title of the study (Brief title)	A phase II neoadjuvant trial of sequential nab-paclitaxel followed by FEC in operable breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemotherapy of sequential nab-paclitaxel followed by 5-fluorouracil/epirubicine/cyclophosphamide (FEC) in operable breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Clinical response
Key secondary outcomes	Pathological complete response (pCR) Safety

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	neoadjuvant sequential 4 cycle nab-paclitaxel tri-weekly, with trastuzumab in HER2-positive patients, followed by 4 cycle 5-fluorouracil/epirubicine/cyclophosphamide (FEC) tri-weekly nab-paclitaxel 4cycle nab-paclitaxel 260mg/m2, day1, q3w HER2-positive disease, trastuzumab with nab-paclitaxel, 8 mg/kg loading dose on cycle 1, day 1 followed by doses of 6 mg/kg on day 1 of subsequent cycles FEC 4cycle 5-Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2, day 1, q3w
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	Not applicable
Gender	Female
Key inclusion criteria	1)Histologically confirmed operable breast c ancer 2)Clinical stage 1, 2, 3 3)Operable breast cancer in neoadjuvant setting 4)Over 20 year-old female 5)Previously untreated by operation, radiotherapy, chemotherapy, endocrine therapy 6)Exhibited adequate organ function 7)Performance status(PS) 0-1 8)Signed written informed consent
Key exclusion criteria	1)Known hypersensitivity to human serum alb umin 2)Concurrent, serious or uncontrolled infect ions 3)Inadequately controlled or serious history of cardiac disease 4)Confirmed symptomatic brain metastasis 5)Current pregnancy and lactation, or possib ility of pregnancy 6)Known drug allergy to any of study drugs 7)Assessment by investigator that subject un able to comply with protocol
Target sample size	50

Research contact person
Name of lead principal investigator	Yutaka Mizuno
Organization	Yokkaichi Municipal Hospital
Division name	Department of breast surgery
Address	2-2-37 Shibata Yokkaichi-city Mie
TEL	059-354-1111
Email	mizunoy729@yokkaichihp01.jp

Public contact
Name of contact person	Yutaka Mizuno
Organization	Yokkaichi Municipal Hospital
Division name	Department of breast surgery
Address	2-2-37 Shibata Yokkaichi-city Mie
TEL	059-354-1111
Homepage URL
Email	mizunoy729@yokkaichihp01.jp

Sponsor
Institute	Yokkaichi Municipal Hospital
Institute
Department

Funding Source
Organization	Yokkaichi Municipal Hospital
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	市立四日市病院（三重県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 06 Day
Anticipated trial start date	2014 Year 03 Month 20 Day
Last follow-up date
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	2018 Year 04 Month 08 Day
Last modified on	2018 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036679