UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter study of adjuvant nab-paclitaxel followed by FEC for early breast cancer
Title of the study (Brief title)	A study of adjuvant nab-paclitaxel followed by FEC for early breast cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the completion rate and safety of adjuvant nab-paclitaxel followed by FEC
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	completion rate of treatment
Key secondary outcomes	safety, disease free survival, period until the onset of peripheral neuropathy and period to recovery, QOL related to peripheral neuropathy

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	As adjuvant chemotherapy, 4 cycles of nab-paclitaxel 260 mg/m2(with or without Trastuzumab) every 3 weeks followed by 4 cycles of FEC (5-FU 500 mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) 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	Not applicable
Gender	Female
Key inclusion criteria	1) Pathologically confirmed breast cancer 2) Curatively resected 3) Age>=20 4) No more than 6 weeks since surgery 5) No prior therapy(except for surgery) 6) Performance status 0-1 7) Adequate function of important organs (within 14 days before registration) (1). WBC:>=4000/mm3 and <12,000 or Neutrophil:>=2,000/mm3 (2). Platelet:>=100,000/mm3 (3). Hemoglobin:>=9.0g/dL (4). T-Bil:<=1.5mg/dL (5). AST, ALT:<=ULNx2.0 (6). Creatinin:<=1.5mg/dL (7). UCG or MUGA scan, LVEF < 55% (8). ECG, within normal limit 8) Written informed consent
Key exclusion criteria	1) Patients with a history of hypersensitivity to paclitaxel and/or albumin 2) Metachronous bilateral breast cancer 3) Inflammatory breast cancer 4) Active double cancer 5) Other severe complications such as infectious diseases, diarrhea, intestinal palsy, intestinal obstruction, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months and heart failure 6) Pregnant and nursing female 7) Patients with pulmonary fibrosis or interstitial pneumonia 8) Sever bone marrow suppression, renal dysfunction, liver dysfunction 9) History of hypersensitivity reaction 10)Others
Target sample size	60

Research contact person
Name of lead principal investigator	Takao Miyaguni
Organization	Naha City Hospital
Division name	Department of Surgery
Address	2-31-1 Furujima, Naha-City, Okinawa
TEL	098-884-5111
Email	t-miyaguni@nch.naha.okinawa.jp

Public contact
Name of contact person	Kazuo Tamura
Organization	Kyushu Breast Cancer Study Group (KBC-SG)
Division name	Executive office
Address	1-8-17-204 Watanabe-dori, Chuo-ku, Fukuoka
TEL	092-406-4166
Homepage URL	http://www.chotsg.com/kbc-sg/index.html
Email	kbc@chotsg.com

Sponsor
Institute	Kyushu Breast Cancer Study Group (KBC-SG)
Institute
Department

Funding Source
Organization	Non profit organization Clinical hematology oncology study group
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	2017 Year 11 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 03 Month 11 Day
Anticipated trial start date	2014 Year 04 Month 01 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	2017 Year 11 Month 06 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034083