UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer
Title of the study (Brief title)	Neoadjuvant Paclitaxel/Bevacizumab followed by FEC 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	Response rate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Pathological complete response rate, Breast-conserving rate, Overall Survival, Relapse-free survival, Safety

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 Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide)
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) invasive breast cancer by needle biopsy 2) operable primary breast cancer (cStage I~IIIA) 3) ER(-), PgR(-) 4) HER2 negative (IHC 0, 1+ or FISH -) 5) P.S. = 0~1 6) measurable lesions 7) preserving the functions of bone marrow, heart, liver, and kidney 8) written informed consent
Key exclusion criteria	1) drug allergy 2) severe complications (malignant hypertension, congestive heart failure, coronary heart disease, myocardial infarction (onset within 6 months), arrhythmia (treated), infectious disease, bleeding tendency, etc) 3) feber, infection 4) peripheral neuropathy 5) pleural effusion, pericardial effusion 6) active double cancer 7) inflammatory breast cancer 8) male breast cancer 9) pregnancy 10) severe edema 11) interstitial pneumonia, fibrous lung disease 12) steroid-using patients 13) psychosomatic disease 14) active digestive ulcer 15) unsuitable patients
Target sample size	20

Research contact person
Name of lead principal investigator	Koichiro Tsugawa, M.D.
Organization	St. Marianna University School of Medicine
Division name	Department of Surgery, Division of Breast and Endocrine Surgery
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL	044-977-8111
Email	koitsuga@marianna-u.ac.jp

Public contact
Name of contact person	Koiciro Tsugawa
Organization	St. Marianna University School of Medicine
Division name	Department of Surgery, Division of Breast and Endocrine Surgery
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL	044-977-8111
Homepage URL
Email	koitsuga@marianna-u.ac.jp

Sponsor
Institute	Department of Surgery, Division of Breast and Endocrine Surgery, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Division of Breast and Endocrine Surgery, St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2013 Year 03 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 18 Day
Anticipated trial start date	2013 Year 03 Month 13 Day
Last follow-up date	2014 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 01 Month 31 Day
Date trial data considered complete	2015 Year 02 Month 28 Day
Date analysis concluded	2015 Year 03 Month 31 Day

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

Management information
Registered date	2013 Year 03 Month 13 Day
Last modified on	2018 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011975