UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2-positive breast cancer
Title of the study (Brief title)	The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2- positive breast cancer
Region	Japan

Condition
Condition	HER2-positive breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of tri-weekly trastuzumab and nab-paclitaxel as neoadjuvant chemotherapy for HER2 positive breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Toxicity Overall survival Relapse free survival

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	Nab-paclitaxl 260mg/mm2,q3w 6cycles Trastuzumab 8mg/kg loading dose over 90 min and 6mg/kg second dose over 60 min then 6mg/kg subsequent doses over 30 min,q3w total 6cycles
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)Histologically confirmed breast cancer 2)HER2 overexpression(IHC3+ or IHC2+ and FISH positive) 3) Clinical stage IIA, IIB, IIIA 4) Age >= 20 5) PS (ECOG) 0, 1 6) LVEF more than 55% 7) Adequate organ function 8) Baseline laboratory parameters (within 14 days of registration) Hemoglobin >= 9g/dL WBC >= 4000/mm3 Neutrophil >= 2000/mm3 Platelet >= 100000/mm3 AST, ALT <= ULN*2.5 T-Bil <= 1.5mg/dL Creatinine <= 1.5mg/dL 9) Written informed consent
Key exclusion criteria	1) Pregnant or lactating women 2) Invasive cancer after completion of therapy(less than 5years ) 3) Asynchronous bilateral breast cancer
Target sample size	35

Research contact person
Name of lead principal investigator	Minoru Fujimori
Organization	Tokyo Medical University Ibaraki Medical Center
Division name	Department of breast surgery
Address	3-20-1 Chuo,Ami Inashiki,Ibaraki
TEL	029-887-1161
Email	minoruf@tokyo-med.ac.jp

Public contact
Name of contact person	Kayoko Koshikawa
Organization	Tokyo Medical University Ibaraki Medical Center
Division name	Department of breast surgery
Address	3-20-1 Chuo,Ami Inashiki,Ibaraki
TEL	029-887-1161
Homepage URL
Email	kkoshi@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University Ibaraki Medical Center
Institute
Department

Funding Source
Organization	Tokyo Medical University Ibaraki Medical Center
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	2014 Year 01 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 08 Day
Anticipated trial start date	2014 Year 01 Month 14 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 08 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014949