UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Title of the study (Brief title)	PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to assess the efficacy and safety of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Response rate, rate of breast conserving surgery, frequency and degree of adverse events, remains rate of peripheral neuropathy, QOL survey, Correlation of the QOL survey results and the pCR rate and the response rate

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 weekly Nab-paclitaxel followed by 4 cycles of EC100 weekly nab-Paclitaxel (HER2 negative) Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks (HER2 positive) Nab-Paclitaxel(80mg/m2) day1,8,15 Trastuzumab 2mg/kg day1,8,15,22 (4 mg/kg for the initial dosing) every 4 weeks EC epirubicin 100 mg/m2 and CPA 500 mg/m2 administered intravenously on day 1 of each 3-week cycle
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) Cytological confirmed breast cancer 2) Clinical Stage I-III B 3) Expected to radical operation of post chemotherapy 4) Has measurable region 5) Age 20 or over 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) Performance Status 0-1 8) Adequate function of important organs(within 14 days before registration) WBC >=4,000/mm3 Neutrophil >=2,000/mm3 Platelet >=10.0 x 104/mm3 Hemoglobin >=9.0g/dL AST <=100 IU/L ALT <=100 IU/L T-Bil <=1.5mg/dL Creatinin <=1.5mg/dL
Key exclusion criteria	1) History of hypersensitivity reaction 2) Active double cander 3) Other severe complications, such as infections, diarrhea, uncontrolled angina, myocardial infarction within 6 months, heart failure. 4) Case of contraindication of this drug 5) Patients with peripheral nerve symptoms 6) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 7) Judged ineligible based on physicians' decision
Target sample size	24

Research contact person
Name of lead principal investigator	Shingo Sakata
Organization	Rakuwakai Otowa Hospital
Division name	Breast oncology department
Address	Chinjicho2 Yamashina-ku, Kyoto city, Kyoto, Japan
TEL	+81-75-593-4111
Email	Rakuwadr1198@rakuwadr.com

Public contact
Name of contact person	Shingo Sakata
Organization	Rakuwakai Otowa Hospital
Division name	Breast oncology department
Address	Chinjicho2 Yamashina-ku, Kyoto city, Kyoto, Japan
TEL	+81-75-593-4111
Homepage URL
Email	Rakuwadr1198@rakuwadr.com

Sponsor
Institute	Rakuwakai Otowa Hospital Breast oncology department
Institute
Department

Funding Source
Organization	Rakuwakai Otowa 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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 21 Day
Anticipated trial start date	2016 Year 07 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	2016 Year 06 Month 28 Day
Last modified on	2018 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026428