UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000818 |
|---|---|
| Receipt number | R000000971 |
| Scientific Title | Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy |
| Date of disclosure of the study information | 2007/09/05 |
| Last modified on | 2020/01/21 10:47:56 |
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Basic information
Public title
Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy
Acronym
N-SAS BC 05: Arimidex Extended adjuvant Randomized Study (AERAS)
Scientific Title
Randomized Study to Assess the Efficacy of a Further 5 Years of Anastrozole Treatment for Postmenopausal Women with Breast Cancer Completing 5 Years Anastrozole Containing Adjuvant Endocrine Therapy
Scientific Title:Acronym
N-SAS BC 05: Arimidex Extended adjuvant Randomized Study (AERAS)
Region
| Japan |
Condition
Condition
Hormone-responsive 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
To confirm that CONTINUE (continuation of Anastrozole treatment) is superior in efficacy of disease-free survival to STOP (no additional medication) for postmenopausal women with breast cancer completing 5 years Anastrozole containing adjuvant endocrine therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-Free Survival
Key secondary outcomes
Overall Survival
Distant Disease-Free Survival
Adverse Events
Health Related Quality of Life: 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
No treatment
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
CONTINUE arm: continuation of Anastrozole for 5 years (1 mg/day po QD)
Interventions/Control_2
STOP arm: no-treatment (no additional medication) for 5 years
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Post operative primary breast cancer proven histologically to be invasive breast cancer. Postmenopause at the randomization. The requirement for menopause is to fulfill at least one of following; a)Age>=55, b)Age>=45 and no menstruation for more than 2 years, c)Bilateral ovariectomy.
2)Patient with no usage ofLH-RHa for adjuvant endocrine therapy, and satisfy one of following; a)taking Anastrozole for 5 years as first line chemotherapy, b)Tamoxifen for 2 to 3 years as 1st line chemotherapy, and followed Anastrozole for 2 to 3 years, namely adjuvant endocrine chemotherapy for 5 years.
3)Clinical stage of T1 to T3, N0 to N2, M0 at the first medical examination(operation).
4)At least one of hormone receptor tests(estrogen receptor, progesterone receptor) is positive.
5)Performance status(ECOG) of 0 to 1.
6)Age at randomization <=80.
7)No relapse and contralateral breast cancer during 6 months before randomization.
8)Sufficient organ functions. The laboratory data during 3 months before randomization fulfill all of the following; a)White blood cell >= 3,000/mm3, b)Platelet count >= 100,000/mm3, c)Hemoglobin >= 9.0g/dl, d)Total bilirubin <=1.5mg/dl, e)GOT, GPT <= 2.5 times of normal upper limit, f)Creatinine <=1.5mg/dl, g)No history of myocardial ischemic disease and congestive heart failure, h)Ischemic heart disease and valvular disorder with no-need for treatment.
9)Written informed consent.
Key exclusion criteria
1)Metachronous or synchronous bilateral breast cancer.
2)Invasive carcinoma of other organs(less than 5 years after the last treatment).
3)History of deep venous embolism.
4)History of bone fracture resulted from osteoporosis, and symptom at the randomization.
5)Taking hormone replacement therapy or selective estrogen receptor.
6)Active participant in any other clinical trial.
7)Patients judged inappropriate for this study by the physicians.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Iwase |
Organization
The Cancer Institute Hospital of JFCR(Japanese Foundation for Cancer Research)
Division name
Breast Oncology Center
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL
03-3520-0111
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, 169-0051 JAPAN
TEL
03-5287-2633
Homepage URL
http://www.csp.or.jp/
support@csp.or.jp
Sponsor or person
Institute
AERAS executive committee
Institute
Department
Personal name
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
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中央病院、相原病院、青森県立中央病院、青森市民病院、上尾中央総合病院、足利赤十字病院、安城更生病院、伊勢崎市民病院、一宮市立市民病院、岩手県立中央病院、うえお乳腺外科、浦添総合病院、大垣市民病院、大阪医科大学附属病院、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、大阪ブレストクリニック、大阪労災病院、岡山大学病院、神奈川県立がんセンター、神奈川県立足柄上病院、金沢大学附属病院、がん研究会有明病院、関西医科大学附属枚方病院、関西労災病院、北九州市立医療センター、九州がんセンター、京都桂病院、京都第一赤十字病院、近畿大学医学部附属病院、熊本市立熊本市民病院、熊本赤十字病院、熊本大学医学部附属病院、倉敷中央病院、久留米総合病院、呉医療センター・中国がんセンター、群馬県立がんセンター、群馬大学医学部附属病院、KKR札幌医療センター斗南病院、甲南病院、神戸市立医療センター西市民病院、公立学校共済組合中国中央病院、公立那賀病院、国立がん研究センター中央病院、国立がん研究センター東病院、済生会新潟第二病院、済生会広島病院、埼玉県立がんセンター、さいたま赤十字病院、堺市立総合医療センター、札幌ことに乳腺クリニック、JR東京総合病院、JA静岡厚生連静岡厚生病院、JA広島総合病院、JA北海道厚生連旭川厚生病院、JA北海道厚生連帯広厚生病院、四国がんセンター、静岡県立静岡がんセンター、静岡県立総合病院、静岡市立清水病院、自治医科大学附属病院、渋川医療センター、社会保険中京病院、順天堂大学医学部附属順天堂医院、昭和伊南総合病院、市立秋田総合病院、市立貝塚病院、市立東大阪医療センター、聖隷浜松病院、聖路加国際病院、赤心堂病院、手稲渓仁会病院、東海大学医学部付属病院、東京共済病院、東北大学病院、豊川市民病院、豊橋市民病院、虎の門病院、都立駒込病院、中頭病院、長崎医療センター、長野市民病院、名古屋医療センター、名古屋市立大学病院、名古屋大学医学部附属病院、名古屋第二赤十字病院、新潟県立中央病院、西神戸医療センター、にゅうわ会及川病院、沼津市立病院、博愛会相良病院、函館五稜郭病院、浜松医科大学医学部附属病院、人吉医療センター、兵庫県立がんセンター、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、福井県済生会病院、福井県立病院、福岡大学病院、藤田保健衛生大学病院、別府医療センター、北海道がんセンター、北海道大学病院、松江赤十字病院、松下記念病院、三重県立総合医療センター、三井記念病院、宮良クリニック、八尾市立病院、横浜市立大学附属病院、米子医療センター、りょうクリニック、りんくう総合医療センター
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2007 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000971
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
