UMIN-CTR Clinical Trial

Public title

Randomized Phase II Trial of Anastrozole plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer

Acronym

Neo-ACET BC

Scientific Title

Randomized Phase II Trial of Anastrozole plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer

Scientific Title:Acronym

Neo-ACET BC

Region

Japan

Condition

Estrogen receptor (ER)-positive, HER2-negative postmenopausal primary breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Clinical response rate

Key secondary outcomes

Reduction Rate
Pathological response
Breast-conserving surgery rate
Adverse event rate
Predictive factor

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Shinzaburo Noguchi

Organization

Graduate School of Medicine, Osaka University

Division name

Department of breast and endocrine surgery

Zip code

Address

2-2 Yamadaoka , Suita, Osaka, Japan

TEL

06-6879-3772

Email

Name of contact person

1st name
Middle name
Last name	Takahiro Nakayama

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of breast and endocrine surgery

Zip code

Address

1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan

TEL

06-6972-1181

Homepage URL

Email

Institute

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

Institute

Department

Personal name

Organization

Translational Research Informatics Center, Kobe, Hyogo, Japan

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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）

Date of disclosure of the study information

2011

Year

09

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2010

Year

11

Month

22

Day

Date of IRB

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

Other related information

Registered date

2011

Year

09

Month

29

Day

Last modified on

2018

Year

10

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007636