UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility Phase 2 study of Dose-dense AC or EC followed by PTX for operable breast cancer
Title of the study (Brief title)	Feasibility study of Dose-Dense therapy for early 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 verify a feasibility of neoadjuvant Dose-Dense A(E)C followed by PTX for axillary node-positive, HER2 negative early breast cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	pathological Complete Response rate
Key secondary outcomes	safety (morbidity rate of febrile neutropenia, rate of accomplishment) overall response rate toxicity profile Relative Dose Intensity(RDI)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1. written informed consent 2. more than 20 y.o to 70y.o 3. ECOG PS 0-2 4. diagnosis of invasive breast cancer 5.HER2 negative 6. more than cN1 7. visceral function 8. LVEF more than 50%
Key exclusion criteria	1. distant metastasis 2. pregnancy or breast feeding 3. history of drug allergy 4. active infection 5. uncontrollable psychosis
Target sample size	50

Research contact person
Name of lead principal investigator	Daisuke Takabatake
Organization	Kochi Health Science Center
Division name	breast surgery
Address	2125-1 Ike Kochi
TEL	088-837-3000
Email	bata@khsc.or.jp

Public contact
Name of contact person	Tadahiko Shien
Organization	Okayama University Hospital
Division name	breast surgery
Address	2-5-1 shikata Okayama
TEL	086-235-7265
Homepage URL
Email	yshien@md.okayama-u.ac.jp

Sponsor
Institute	NPO Setouchi Breast Project
Institute
Department

Funding Source
Organization	NPO Setouchi Breast Project
Organization
Division
Category of Funding Organization	Non profit foundation
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	多施設共同

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2017 Year 08 Month 31 Day
Date of closure to data entry	2017 Year 08 Month 31 Day
Date trial data considered complete	2017 Year 08 Month 31 Day
Date analysis concluded	2017 Year 08 Month 31 Day

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

Management information
Registered date	2016 Year 04 Month 27 Day
Last modified on	2017 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024792