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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001090
Receipt No. R000001119
Scientific Title Randomized Phase III Study of Adjuvant Endocrine-Therapy with or without Chemotherapy for Postmenopausal Breast Cancer Patients who Responded to Neoadjuvant Letrozole
Date of disclosure of the study information 2008/03/20
Last modified on 2018/10/12

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Basic information
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
Condition postmenopausal primary breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute NEOS executive committee
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2008 Year 03 Month 19 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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