UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Title of the study (Brief title)	A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for 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 efficacy and safety of nab-paclitaxel followed by FEC for the treatment of operable breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	pathological complete response rate
Key secondary outcomes	response rate,safety

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	4 cycles of nab-paclitaxel followed by 4 cycles of FEC Nab-paclitaxel nab-paclitaxel: 260mg/m2, iv, day 1 every 3 weeks FEC Epi-ADM 90 mg/m2 and CPA 600 mg/m2 iv,day 1 every 3 weeks
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 confirmed Breast cancer 2) Clinical T1-3, N0-2, M0 cases and expected to radical cure by operation and neoadjuvant chemotherapy 3) ER,PgR and HER2 statuses are confirmed by needle biopsy 4) Age between 20 and 70 years 5) has measurable region 6) No prior therapy for present primary breast cancer 7) ECOG performance status 0 to 1 8) Required baseline laboratory parameters (within 2 weeks before registration): WBC 12,000 /mm3> >= 4000 /mm3 Neu >= 2000 / mm3 Plt >= 100,000/mm3 Hb >= 10.0g/dl AST <= ULNx2.5 ALT <= ULNx2.5 T-Bil <= 1.5mg/dL Creatinin <=1.5 mg/dL ECG normal 9) Written IC Ccr <=50 ml/min
Key exclusion criteria	1) with history of cardiac dysfunction 2) with sever complications ex.)with incontrollable diabetes,with infection,hypertension, renal insufficiency, liver failure and mental disorder which become problem on clinical practice 3) during pregnancy or lactation 4) with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) . 5) with bilateral breast cancer 6) with pulmonary fibrosis or pneumonitis 7) allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 8) with peripheral neuropathy 9) HBs antigen is positive 10) patients judged by the investigator as unfit to be enrolled in the study
Target sample size	40

Research contact person
Name of lead principal investigator	Shoichiro Ootani
Organization	Hiroshima city hospital
Division name	Breast surgery
Address	7-33 Moto-machi Naka-ku Hiroshima-shi
TEL
Email

Public contact
Name of contact person
Organization	Hiroshima city hospital
Division name	Breast surgery
Address
TEL	082-221-2291
Homepage URL
Email

Sponsor
Institute	Hiroshima city hospital
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	2013 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 22 Day
Anticipated trial start date	2013 Year 01 Month 16 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 09 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011410