UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and feasibility study of docetaxel + capecitabine followed by FEC neoadjuvant therapy for hormone receptor positive and HER2 negative breast cancer
Title of the study (Brief title)	docetaxel + capecitabine followed by FEC neoadjuvant therapy for triple negative breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To examine efficacy and feasibility of Docetaxel + Capecitabine followed by FEC100 neoadjuvant chemotherapy for triple negative breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	pathological CR rate, Feasibility, Overal response rate
Key secondary outcomes	Adverse effects

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	Neoadjuvant Chemotherapy Docetaxel + Capecitabine q 3wks x 3 cycles follwed by FEC q 3wks x 3 cycles
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 confirmed ER and PgR negative, HER2 negative invasive breast cancer. 2 ECOG PS 0-1 3 Tumor size >=1cm,N0-2, M0 4 Adequate visceral function 1) WBC >=3000/mm3 2) Hb >=8.0g/dL 3) Platelet >=100000/mm3 4) Total bilirubin <=1.5mg/dL 5) AST/ALT <= x 2.5 upper normal limits 6) serum Cr <=1.5mg/dL 5 Written informed consent
Key exclusion criteria	1 HER2 positive 2 Pregnant or breast feeding 3 Severe infectious disease 4 Active another cancer 5 Hypersensitivity for 5FU, docetaxel or polysolvate 6 Investigator's judgement of inappropriateness for perticipation
Target sample size	20

Research contact person
Name of lead principal investigator	Tsutomu Takashima
Organization	Osaka City University Graduate School of Medicine
Division name	Surgical Oncology
Address	1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL	06-6645-3838
Email	tsitomu-@rd5.so-net.ne.jp

Public contact
Name of contact person	Tsutomu Takashima
Organization	Osaka City University Graduate School of Medicine
Division name	Surgical Oncology
Address	1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL	06-6645-3838
Homepage URL
Email	tsitomu-@rd5.so-net.ne.jp

Sponsor
Institute	Department of Surgical Oncology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgical Oncology, Osaka City University Graduate School of Medicine
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	大阪市立大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 25 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 10 Month 28 Day
Anticipated trial start date	2012 Year 11 Month 20 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	2014 Year 02 Month 25 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014186