UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Title of the study (Brief title)	Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the efficacy and safety of EC followed by weekly Nab-paclitaxel as neoadjuvant chemotherapy for primary 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 clinical response rate pathological response rate rate of breast-conserving surgery feasibility overexpression rate of SPARC

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 EC followed by 4 cycles of weekly nab-paclitaxel EC Epi-ADM 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle weekly nab-paclitaxel nab-paclitaxel 150 mg/m2 administered weekly on days 1, 8, and, 15 of each 4-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	Histologically confirmed primary breast cancer Clinical stage T1c-3 N0/M0 or T1-3 N1/M0 At least one measurable lesion over 20 years old No prior surgery, radiation, chemotherapy and endocrine therapy Adequate baseline organ function (within 14 days before registration) Hb--over 8.0 g/dL WBC--over 3000 /mm3 and under 12,000 /mm3 Neu--over 2,000 / mm3 Plt--over 75,000 / mm3 T-Bil--under 3 times ULM AST/ALT--under 3 times ULN Cre--under ULN ECOG performance status--0-2 written informed consent
Key exclusion criteria	past medical history of drug allergy HER2 positive breast cancer (IHC 3+, IHC 2+ and FISH +) Active double cancer Severe complications Symptomatic brain metastasis Severe mental disorder History of blood transfusions within 2 weeks Sever bone marrow suppression, renal dysfunction, liver dysfunction Body cavity fluid watery diarrhea on registration Active infection or potentiality infection allergic reaction of the nab-paclitaxel, paclitaxel or albumin During pregnancy or lactation Judged by the investigator to be unfit to be enrolled into the study
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuhiro Suzuki
Organization	Tokai University School of Medicine
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Address	143 Shimokasuya, Isehara-shi, Kanagawa, Japan 259-1193
TEL	+81-463-93-1121
Email	luke-szk@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Yasuhiro Suzuki
Organization	Tokai University School of Medicine
Division name	Division of Breast and Endocrine Surgery, Department of Surgery
Address	143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL	+81-463-93-1121
Homepage URL
Email	luke-szk@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
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	2011 Year 07 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 22 Day
Anticipated trial start date	2011 Year 08 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	2011 Year 07 Month 22 Day
Last modified on	2019 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007125