UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of nab-paclitaxel combined with S-1 in patients with early breast cancer:A multicenter clinical trial
Title of the study (Brief title)	nab-paclitaxel + S-1 for early breast cancer
Region	Japan

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

Objectives
Narrative objectives1	The efficacy and safety of preoperative chemotharapy with S-1/nab-Paclitaxel follwed by epirubicin(doxorubicin)/cyclophosphamide for early breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pathological complete response rate (ypT0/is ypN0)
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	Administrate 4 cycles of nab-Paclitaxel and S-1 therapy. Nab-paclitaxel (220 mg/m2) intravenously on day 1 of each 3 weeks.S-1 given orally twice daily for 14 consecutive days, followed by a 7-day rest. After 4 cycles of nab-Paclitaxel and S-1 therapy, adminiatrate 4 cycles of EC(AC)therapy.Operation is to be performed after chemotherapy. For patients with HER2 positive breast cancer, trastuzumab intravenousy on day 1 of each 3-weeks in nab-Paclitaxel and S-1 therapy.
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)Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (Stage IIA-Stage IV)and tumor size is 2cm or larger. (2)Age between 20 to 75 years old. (3)ECOG performance status (PS):0-1 (4)A survival expectancy of 6 months or longer. (5)Results from a laboratory test meet the following A)Leukocyte count is >=3,500/mm3 and <=12,000/mm3 B)Neutrophil count is >=2000/mm3 C)Platelet >=100,000/mm3 D)Hemoglobin >=9g/dl E)Serum creatinine <= *2 of ULN F)Ccr>=60ml/min G)Total bilirubin <= 1.5mg/dl H)AST/ALT <= *1.5 of ULN (6)Signed written informed concent.
Key exclusion criteria	(1)DCIS or breast cancer wiht micro invasion. (2)Patients with contraindication for any agents necessary in the planned treatment (3)Male (4)Women who are pregnant, lactating or with childbearing potential. (5)Patients with a history of chemotherapy, endocrinetherapy or radiotherapy. (6)Multiple primary cancer. (7)Serious complications(diabetes infection or mental disorder) (8)Serious complications with cardiac function (9)Patients with serious edema (10)Hypersensitivity to any agents necessary in the planned treatment. (11)Ineligible based on decision of a investigator.
Target sample size	80

Research contact person
Name of lead principal investigator	Akira Tangoku
Organization	The University of Tokushima Graduate School
Division name	Depertment of Thoracic, Endocrine surgery and Oncology
Address	3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503
TEL	088-633-7143
Email	tangoku@tokushima-u.ac.jp

Public contact
Name of contact person	Masami Morimoto
Organization	The University of Tokushima Graduate School
Division name	Depertment of Thoracic, Endocrine surgery and Oncology
Address	3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503
TEL	088-633-7143
Homepage URL
Email	twop8air@tokushima-u.ac.jp

Sponsor
Institute	The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization	The University of Tokushima Graduate School
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 05 Month 08 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 06 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 01 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031143