UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Phase II Trial of Anastrozole plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Title of the study (Brief title)	Neo-ACET BC
Region	Japan

Condition
Condition	Estrogen receptor (ER)-positive, HER2-negative postmenopausal primary breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for estrogen receptor (ER)-positive, HER2-negative postmenopausal primary breast cancer.
Basic objectives2	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	Reduction Rate Pathological response Breast-conserving surgery rate Adverse event rate Predictive factor

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Group A: Anastrozole (1mg/day) is administrated orally on 24 weeks daily.
Interventions/Control_2	Group B: Anastrozole (1mg/day) is administrated orally on 24 weeks. UFT (270mg/m2/day) is administrated orally on 24 weeks daily.
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.Histologically-confirmed diagnosis of invasive breast cancer 2.Clinical stage T2, N0 or N1, M0 (TNM Classification) 3.Patients must be postmenopausal (1) Patients aged more than 60 years (2) Patients aged more than 45 years and less than 60 years old with amenorrhea (more than one year). (3) Patients who underwent bilateral oophorectomy. 4. ER-positive breast cancer (IHC: positive cells >= 10%) 5.HER2-negative breast cancer (1) IHC:<=2 (2) FISH: negative 6.ECOG Performance status (PS) 0 or 1 7.Oral intake is possible 8.Candidates for mastectomy or breast-conserving surgery 9.Adequate bone marrow, liver and renal function 10.Written informed consent was obtained from all patients before randomization.
Key exclusion criteria	1.Inoperable, multiple, bilateral (synchronous or asynchronous) or inflammatory breast cancer 2.Personal history of invasive carcinoma 3.Patients receive systemic therapy of corticosteroid 4.Patients receive estrogen preparation or raloxifene 5.Patients with other concurrent severe and/or uncontrolled medical disease 6.Patients whom doctors judged inadequate to the enrollment of this study by other reasons.
Target sample size	120

Research contact person
Name of lead principal investigator	Shinzaburo Noguchi
Organization	Graduate School of Medicine, Osaka University
Division name	Department of breast and endocrine surgery
Address	2-2 Yamadaoka , Suita, Osaka, Japan
TEL	06-6879-3772
Email

Public contact
Name of contact person	Takahiro Nakayama
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of breast and endocrine surgery
Address	1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan
TEL	06-6972-1181
Homepage URL
Email

Sponsor
Institute	Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Translational Research Informatics Center, Kobe, Hyogo, Japan
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	YES
Study ID_1	NCT01262274
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪大学医学部附属病院（大阪府）、大阪府立急性期総合医療センター（大阪府）、大阪厚生年金病院（大阪府）、東大阪市立総合病院（大阪府）、NTT西日本大阪病院（大阪府）、大阪警察病院（大阪府）、日生病院（大阪府）、大阪府立成人病センター（大阪府）、八尾市立病院（大阪府）、大阪医療センター（大阪府）、大阪市立大学医学部附属病院（大阪府）、大阪労災病院（大阪府）、市立堺病院（大阪府）、りんくう総合医療センター（大阪府）、大阪医科大学附属病院（大阪府）、吹田市民病院（大阪府）、相原病院（大阪府）、慶應義塾大学医学部附属病院（東京都）、石川県立中央病院（石川県）、金沢大学附属病院（石川県）、兵庫医科大学病院（兵庫県）、関西労災病院（兵庫県）、京都府立医科大学附属病院（京都府）、相良病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 11 Month 22 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2013 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	2011 Year 09 Month 29 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007636