UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Title of the study (Brief title)	PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Region	Japan

Condition
Condition	HER2 positive resectable primary breast cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate effectiveness and safety of Tri-Weekly nab Paclitaxel+Trastuzumab followed by FEC therapy as chemotherapy in preoperation for HER2-positive resectable primary breast cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological complete response rate
Key secondary outcomes	Overall response rate Breast conserving rate Adverse events

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 FEC after 4 cycles of nab Paclitaxel and Trastuzumab. Operation is to be performed after chemotherapy. nab Paclitaxel and Trastuzumab 4 cycles nab Paclitaxel 260mg/m2 iv day1 q3w Trastuzumab 6 mg/kg iv day1 q3w (8 mg/kg in only first course) FEC 4 cycles 5-Fluorouracil 500mg/m2 iv day 1 q3w Epirubicin 100mg/m2 iv day 1 q3w Cyclophosphamide 500mg/m2 iv day 1 q3w
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. Histologically invasive breast cancer 2. Stage I-IIIA (T1c-3, N0-2a,M0) 3. An age of 20 years to 70 years 4. Hormonal receptor status is confirmed. 5. HER2 status, is confirmed. 1)IHC 3+ 2) FISH score>2.2 6. PS 0-1 7. Measurable lesion according to RECIST standard 8. No prior treatment for breast cancer 9. LVEF more than 55% 10. Adequate EKG 11. Required baseline laboratory data WBC > 4,000/mm3 Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST < ULNx2.5 ALT< ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl 12. Written informed consent
Key exclusion criteria	1. Current history of malignant neoplasm. 2. Bilateral invasive breast cancer. 3. Cases who does not wish to undergo an operation after neoadjuvant chemotherapy. 4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus. 5. Has history of hypersensitivity reaction in important drug of this study. 6. Positive for HBs antigen. 7. 8. With severe peripheral neuropathy. 9. Transfusion within the past 2 weeks. 10. With the history of severe mental disease or under treatment. 11. With active pleural effusion or ascites. 12. Pregnancy, or suspected pregnancy. 13. Cases who physician judged improper to entry this trial.
Target sample size	30

Research contact person
Name of lead principal investigator	Shinya Tokunaga
Organization	Osaka City General Hospital
Division name	Department of Medical Oncology
Address	2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL	06-6929-1221
Email	s-tokunaga@med.osakacity-hp.or.jp

Public contact
Name of contact person	Shinya Tokunaga
Organization	Osaka City General Hospital
Division name	Department of Medical Oncology
Address	2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL	06-6929-1221
Homepage URL
Email	s-tokunaga@med.osakacity-hp.or.jp

Sponsor
Institute	Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Institute
Department

Funding Source
Organization	None
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	2012 Year 07 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 26 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 04 Month 30 Day

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

Management information
Registered date	2012 Year 07 Month 18 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009814