UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of neoadjuvant docetaxel/cyclophosphamide (DC) followed by epirubicin/cyclophosphamide (EC) for triple-negative breast cancer
Title of the study (Brief title)	DC followed by EC as NAC PII
Region	Japan

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

Objectives
Narrative objectives1	The aim of this phase II study is to evaluate the efficacy and toxicity of docetaxel/cyclophosphamide (DC) followed by epirubicin/cyclophosphamide (EC) as a neoadjuvant therapy for the treatment of triple-negative breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	pathological CR(pCR rate)
Key secondary outcomes	the breast conserving rate, toxicities, ki-67 labeling index, feasibility and overall 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	DC (DTX75mg/m2, CPA600mg/m2 q3w x4courses) followed by EC(EPI90mg/m2, CPA600mg/m2 q3w x4courses)as a neoadjuvant therapy
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	Male and Female
Key inclusion criteria	Patients with histologically diagnosed invasive breast cancer Resectable case Category of the T1-4 N1-3 M0 or T2-4N0M0 Without previous operation or chemotherapy With measurable lesions ECOG performance status 0-2 Adequate organ function Written informed concent
Key exclusion criteria	Severe complications history of hypersensitivity reaction for important drug in this study Bilateral breast cancer Inflammatory breast cancer Pregnant or nursing women
Target sample size	34

Research contact person
Name of lead principal investigator	Tadao Shimizu
Organization	Tokyo Women's Medical University, Medical Center East
Division name	Department of Breast Surgery
Address	2-1-10, Nishi-ogu, Arakawa-ku, Tokyo, Japan
TEL	03-3810-1111
Email	shimitsu@dnh.twmu.ac.jp

Public contact
Name of contact person	Akira Hirano
Organization	Tokyo Women's Medical University, Medical Center East
Division name	Department of Breast Surgery
Address	2-1-10, Nishi-ogu, Arakawa-ku, Tokyo, Japan
TEL	03-3810-1111
Homepage URL
Email	ahirasu@dnh.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Women's Medical University, Yachiyo Medical Center
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	東京女子医科大学東医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 24 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 12 Day
Anticipated trial start date	2013 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	2013 Year 06 Month 24 Day
Last modified on	2018 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012915