UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel(nanoparticle albumin-bound paclitaxel) for the operable breast cancer (KSCOG-BC07)
Title of the study (Brief title)	Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel for the operable breast cancer (KSCOG-BC07)
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 FEC followed by weekly nab-Paclitaxel for the operable breast cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Preserving operation rate, Clinical response rate, Safety, etc.

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	(FEC100) Fluorouracil(500mg/m2) day1 Epirubicin(100mg/m2) day1 Cyclophosphamide(500mg/m2) day1 every 3weeks x 4cycles. (weekly nab-Paclitaxel) nab-Paclitaxel(100mg/m2) day1,8,15 (HER2 positive) nab-Paclitaxel(100mg/m2) day1,8,15 Trastuzumab*(2mg/kg) day1,8,15,22 *:4 mg/kg for the initial dosing(day1) every 4 weeks x 4 cycles.
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)No prior treatment for breast cancer and clinical stage T1-3,N0-2,M0 2)Written informed consent to participate 3)Suitable judgement by physician 4)Histological and/or cytological confirmed breast cancer 5)Age 20 or over 6)Performance status (ECOG) 0-1 7)The below criteria met within 14 days prior to therapy 1 WBC between 4,000/mm3 and 12,000/mm3 2 Granulocyte count 2,000/mm3 or more 3 Platelet count 100,000/mm3 or over 4 Hb 9.0 g/dl or more 5 AST and ALT ULNx2.0 or less 6 Total bilirubin 1.5 mg/dL or less 7 Serum creatinine 1.5 mg/dl or less 8 ECG normal 9 Left ventricle ejection fraction 55 % or more by cardiac sonography or MUGA scan
Key exclusion criteria	1)Heart failure with clinically problem or history of cardiac dysfunction 2)Severe complication (uncontrolled diabetes, hypertension, renal failure, hepatic failure, Severe Infection and mental disorder which become problem on clinical practice) 3)Pregnancy and lactation or suspected pregnancy 4)Active secondary malignancy (current secondary malignancy or other malignancy within 5 years) 5)Bilateral breast cancer 6)Pulmonary fibrosis or pneumonitis 7)Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil 8)Physician judged improper to entry this trial
Target sample size	30

Research contact person
Name of lead principal investigator	Toh Uhi
Organization	Kurume University School of Medicine
Division name	Department of Surgery
Address	67 Asahi-machi,Kurume city,Fukuoka
TEL	0942-31-7566
Email	utoh@med.kurume-u.ac.jp

Public contact
Name of contact person	same as above
Organization	Kurume University School of Medicine
Division name	Department of Surgery
Address	67 Asahi-machi,Kurume city,Fukuoka
TEL	0942-31-7566
Homepage URL
Email	utoh@med.kurume-u.ac.jp

Sponsor
Institute	Department of Surgery Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Kurume University Department of Surgery
Organization
Division
Category of Funding Organization	Other
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 04 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 04 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 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 04 Month 16 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012286