UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Title of the study (Brief title)	Phase II study of Nab-paclitaxel followed by FEC 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 was to assess the efficacy and safety of Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for the operable 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	adverse event, quasi pathological complete response rate, response rate, rate of breast conserving surgery

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 FEC100 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 FEC 5-FU 100mg/m2, 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-IIIB 3) Expected to radical cure by operation and neoadjuvant chemotherapy 4) Has measurable region 5) Age 20 or over 6) No prior surgery, radiation, chemotherapy and endocrine therapy 7) Adequate function of important organs (within 14 days before registaration) 1. WBC: >=4,000/mm3 2. Neutrophil: >=2,000/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T-Bil <= ULN x 2.5 6. AST <= ULN x 1.5 7. ALT <= ULN x 1.5 8. Creatinin <= 1.5mg/dL 8) ECOG performance status 0-1 9) Written informed consent
Key exclusion criteria	1) History of hypersensitivity reaction 2) Active double cancer 3) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure. 4) Severe mental disorder 5) Sever bone marrow suppression, renal dysfunction, liver dysfunction 6) Has watery diarrhea 7) Active infection or potentiality infection 8) History of hypersensitivity for albumin 9) Grade2 or grater peripheral neuropathy 10) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant 11) Judged ineligible based on physicians' decision
Target sample size	20

Research contact person
Name of lead principal investigator	Hirohito Seki
Organization	Kitasato University Kitasato Institute Hospital
Division name	Breast Center
Address	Shirokane5-9-1 Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
Organization	Kitasato University Kitasato Institute Hospital
Division name	Breast Center
Address	Shirokane5-9-1 Minato-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute	Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization	Kitasato University Kitasato Institute 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	2013 Year 06 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 12 Day
Anticipated trial start date	2013 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry	2019 Year 02 Month 04 Day
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	2013 Year 06 Month 26 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012931