UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Title of the study (Brief title)	Neo CR
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of anthracycline, paclitaxel and radiotherapy in the neoadjuvant setting for operable breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	pathological complete response rate
Key secondary outcomes	clinical response rate disease free survival rate of breast-conserving surgery adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	neoadjuvant chemotherapy and radiotherapy
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1) biopsy-proven invasive breast cancer 2) TNM classification: T2-T4, N0-2, M0 3) HER2-negative tumor 4) PS (ECOG): 0 or 1 5) Normal bone marrow, liver and renal function 6) Patients who have never received any treatment for breast cancer 7) Written informed consent is obtained
Key exclusion criteria	1) past history of any invasive malignancy within the previous 5 years 2) past history of breast cancer or synchronous bilateral breast cancer 3) past history of radiotherapy for ipsilateral breast 4) Suspicious of allergy for radiotherapy 5) Suspicious of allergy for paclitaxel, 5FU, epirubicin or cyclophosphamide 7) Patients during uncontrollable diabetes or psychologic disorder 8) Patients who have grade3-4 neuropathy 9) Pregnant or breast-feeding 10) Any reason the physician believes that the patient is not appropriate to participate in the study
Target sample size	35

Research contact person
Name of lead principal investigator	Makoto Ishitobi
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Breast and Endocrine Surgery
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL	0669721181
Email

Public contact
Name of contact person
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Breast and Endocrine Surgery
Address
TEL
Homepage URL
Email	isitobi-ma@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
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

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 26 Day
Anticipated trial start date	2010 Year 10 Month 26 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	2010 Year 10 Month 27 Day
Last modified on	2017 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005344