UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of neoadjuvant chemotherapy with nab-paclitaxel followed by FEC in patitents with operable breast cancer
Title of the study (Brief title)	A phase II study of NAC with nab-paclitaxel for breast cancer
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel followed by FEC in patients with operable breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of pathological complete response (pCR rate)
Key secondary outcomes	Breast-conserving surgery (BCS) rate, objective response rate (ORR), safety, disease-free survival, overall survival, pCR rates, ORR and BCS rates based on subtype. ORR and safety during nab-paclitaxel treatment.

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	Patients receive nab-paclitaxel 260 mg/m2 intravenously on a 21-day schedule for 4 cycles. After that, patients receive epirubicin 100mg/2, fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 intravenously on a 21-day schedule for 4 cycles.Patients receive surgery for breast cancer after neoadjuvant chemotherapy.
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	70 years-old >=
Gender	Female
Key inclusion criteria	Histologically confirmed breast cancer Clinical stage I - IIIB (T1-3, N0-2, M0) ER, PgR and HER2 status are confirmed Having measurable lesion according to RECIST version 1.1 No previous treatment for breast cancer Having Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Having adequate organ function Providing written informed consent for this trial
Key exclusion criteria	Having significant cardiovascular disease and a history of that Having significant complications such as uncontrolled hypertension and diabetes mellitus, renal failure, liver failure, clinically significant infection and mental disorder Pregnant, breast feeding and case of possibility of pregnancy Bilateral breast cancer with concurrent or metachronism Pulmonary fibrosis or interstitial pneumonia Having a known hypersensitivity to the components of the study therapy Cases judged unsuitable by the physician
Target sample size	40

Research contact person
Name of lead principal investigator	Yutaka Yamamoto
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Breast and Endocrine Surgery
Address	1-1-1 Honjyo, Chuo-ku, , Kumamoto,860-8556, Japan
TEL	096-373-5521
Email	ys-yama@triton.ocn.ne.jp

Public contact
Name of contact person	Kazuo Tamura
Organization	Clinical Hematology Oncology Treatment Study Group
Division name	Kyushu Breast Cancer Study Group
Address	1-8-17-204, Watanabe douri, Chuo-ku, Fukuoka, 810-0004, Japan
TEL	092-406-4166
Homepage URL	http://www.chotsg.com/kbc-sg/index.html
Email	kbc@chotsg.com

Sponsor
Institute	kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization	kyushu Breast Cancer Study Group
Organization
Division
Category of Funding Organization	Other
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	2018 Year 01 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

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

Management information
Registered date	2018 Year 01 Month 05 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035036