UMIN-CTR Clinical Trial

Public title

Randomized Phase III Study of Adjuvant Endocrine-Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients who Responded to Neoadjuvant Letrozole

Acronym

N-SAS BC 06: New primary Endocrine-therapy Origination Study(NEOS)

Scientific Title

Randomized Phase III Study of Adjuvant Endocrine-Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients who Responded to Neoadjuvant Letrozole

Scientific Title:Acronym

N-SAS BC 06: New primary Endocrine-therapy Origination Study(NEOS)

Region

Japan

Condition

postmenopausal primary breast cancer

Classification by specialty

Hematology and clinical oncology	Surgery in general	Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of the necessity of adjuvant chemotherapy for postmenopausal breast cancer patients responded to neoadjuvant letrozole.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Disease-Free Survival(DFS)

Key secondary outcomes

Overall Survival(OS),
Clinical response rate for neoadjuvant letrozole,
Pathological response,
Breast-conserving surgery rate,
DFS and OS by the clinical response (CR / PR / SD / PD) of neoadjuvant letrozol,
Safety, HRQOL, Cost-Effectiveness(QALY)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CL(chemotherapy*-letrozole) : letrozole for 4.5-5.0 years (2.5mg/day po QD) after chemotherapy* .
*one of the following regimens: CMF, AC, EC, TC, FAC, FEC, AC-T/EC-T, FEC-T, TAC

Interventions/Control_2

L (letrozole) : letrozole for 4.5-5.0 years (2.5mg/day po QD)

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

75

years-old

>=

Gender

Female

Key inclusion criteria

1. Postmenopausal women with histological confirmed invasive breast cancer at diagnosis.
The criteria for determining
menopause include any of the following:
a)Age 60 y
b)Age < 60 y and amenorrheic for 12 or more months
c)Prior bilateral oophorectomy

2. TNM: T1c-T2, N0, M0.

3. ER-positive by core needle biopsy before treatment.

4. HER2 <=2+ by core needle biopsy before treatment and/or FISH (-) before the registration.

5. Age<=75 years old at the registration.

6. PS(ECOG): 0, 1.

7. No prior treatment for breast cancer before the registration.

8. Adequate main organ functions.
WBC >=3,000/mm3,
PLT >=100,000/mm3,
GOT, GPT <=ULN*2.5,
Cre<1.5mg/dL,
No concurrent treatment for cerebral infarction at the registration.
No history of myocardial infarction and congestive heart failure.
No need for treatment of ischemic heart disease and valvular disorder.

9. Written informed consent.

Key exclusion criteria

1. Positive sentinel lymph nodes before the registration.
2. Synchronous or asynchronous bilateral breast cancer.

3. Multifocal breast cancer of plural region
4. Double invasive carcinoma (in less than 5 years after the last treatment).

5. History of breast cancer.
6. Under treatment with continuous systemic steroid, estrogen or SERM.
7. Active participant in any other clinical trial for breast cancer.
8. Patient judged inappropriate for this study by the physicians.

Target sample size

850

Name of lead principal investigator

1st name
Middle name
Last name	Hiroji Iwata

Organization

Aichi Cancer Center

Division name

Department of Breast Oncology

Zip code

Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan

TEL

052-762-6111

Email

no@mail

Name of contact person

1st name
Middle name
Last name	Akira Yamao

Organization

Public Health Research Foundation

Division name

Comprehensive Support Project for Clinical Research

Zip code

Address

1-1-7, Nishiwaseda, Shinjyuku-ku, Tokyo, 169-0051JAPAN

TEL

03-5287-2633

Homepage URL

http://www.csp.or.jp/

Email

support@csp.or.jp

Institute

NEOS executive committee

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛知県がんセンター愛知病院、愛知県がんセンター中央病院、青森県立中央病院、青森市民病院、安城更生病院、石川県立中央病院、伊勢崎市民病院、岩手医科大学附属病院、大阪医療センター、大阪警察病院、大阪府済生会富田林病院、大阪労災病院、岡山大学病院、香川県立中央病院、神奈川県立がんセンター、金沢大学附属病院、川崎医科大学附属病院、がん研究会有明病院、関西医科大学附属枚方病院、北九州市立医療センター、九州がんセンター、京都桂病院、杏林大学医学部付属病院、近畿大学医学部附属病院、熊本大学医学部附属病院、久留米総合病院、久留米大学病院、群馬県立がんセンター、群馬大学医学部附属病院、慶應義塾大学病院、神戸市立医療センター西市民病院、公立那賀病院、国立がん研究センター東病院、小牧市民病院、済生会新潟第二病院、済生会兵庫県病院、埼玉医科大学国際医療センター、堺市立総合医療センター、札幌医科大学附属病院、JA広島総合病院、JA北海道厚生連旭川厚生病院、四国がんセンター、静岡県立総合病院、静岡県立静岡がんセンター、自治医科大学附属病院、渋川医療センター、島田乳腺・外科クリニック、市立釧路総合病院、市立吹田市民病院、神鋼病院、聖隷浜松病院、聖路加国際病院、高崎総合医療センター、千葉県がんセンター、千葉大学医学部附属病院、筑波大学附属病院、手稲渓仁会病院、東京女子医科大学東医療センター、東北公済病院、東北大学病院、富山県立中央病院、豊田厚生病院、都立駒込病院、中頭病院、長崎医療センター、名古屋市立大学病院、名古屋市立東部医療センター東市民病院、名古屋セントラル病院、名古屋大学医学部附属病院、名古屋第二赤十字病院、那覇西クリニック、新潟県立中央病院、新潟大学医歯学総合病院、西神戸医療センター、日本海総合病院、日本生命済生会付属日生病院、博愛会相良病院、函館五稜郭病院、函館中央病院、浜の町病院、人吉医療センター、兵庫医科大学病院、兵庫県立がんセンター、兵庫県立塚口病院、弘前市立病院、広島市立安佐市民病院、広島市立広島市民病院、広島大学病院、福岡県済生会福岡総合病院、北海道がんセンター、北海道大学病院、三重県立総合医療センター、三井記念病院、八尾市立病院、山口大学医学部附属病院、大和市立病院、横浜旭中央総合病院、横浜市立大学附属市民総合医療センター、横浜市立大学附属病院、りんくう総合医療センター

Date of disclosure of the study information

2008

Year

03

Month

20

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

No longer recruiting

Date of protocol fixation

2008

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2008

Year

05

Month

16

Day

Last follow-up date

2023

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

03

Month

19

Day

Last modified on

2023

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001119