UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of NEOadjuvant Anastrozole and RadioTherapy for hormone-responsive postmenopausal breast cancer (NEO-A-RT)
Title of the study (Brief title)	Prospective study of NEOadjuvant Anastrozole and RadioTherapy for hormone-responsive postmenopausal breast cancer (NEO-A-RT)
Region	Japan

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

Objectives
Narrative objectives1	Our aim of this trial is to assess the usefulness and feasibility of neoadjuvant anastrozole and radiotherapy for hormone-responsive postmenopausal breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Clinical response rate
Key secondary outcomes

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 Maneuver
Interventions/Control_1	Patients will receive anastrozole 1mg daily for 24 weeks and receive radiotherapy (50Gy / 25 fr) at 13 weeks from the start of anastrozole. Patients will receive surgery at 24 weeks.
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) Postmenopausal patients with biopsy-proven invasive breast cancer 2) TNM classification: T2 (3cm and larger)-T4, N0-2, M0 3) ER-positive tumor (10% or more positively staining by immunohistochemistry) 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) Past use of aromatase inhibitors 6) Suspicious of allergy for aromatase inhibitors 7) Patients who had received or are receiving any steroids, estrogens or selective estrogen receptor modulators 8) 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	06-6972-1181
Email	isitobi-ma@mc.pref.osaka.jp

Public contact
Name of contact person	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	06-6972-1181
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	地方独立行政法人大阪府立病院機構大阪府立成人病センター （大阪府）、独立行政法人国立病院機構四国がんセンター（愛媛県）

Other administrative information
Date of disclosure of the study information	2009 Year 07 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 07 Month 21 Day
Anticipated trial start date	2009 Year 07 Month 21 Day
Last follow-up date	2011 Year 07 Month 01 Day
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	2009 Year 07 Month 29 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=R000002774