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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000056
Receipt No. R000000046
Scientific Title Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients
Date of disclosure of the study information 2005/08/12
Last modified on 2016/02/19

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Basic information
Public title Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients
Acronym Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 03)
Scientific Title Phase III Randomized Adjuvant Study of Tamoxifen Alone Versus Sequential Tamoxifen and Anastrozole in Hormone-Responsive Postmenopausal Breast Cancer Patients
Scientific Title:Acronym Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 03)
Region
Japan

Condition
Condition Hormone-responsive postmenopausal primary breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test equivalency or superiority of Anastorozole to Tamoxifen by changing from Tamoxifen Alone
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
Adverse Events
Key secondary outcomes Relapse-Free Survival
Overall Survival
Health-Related QOL
Efficacy of medical economy

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 TAM:Tamoxifen alone (total 5 years)
Interventions/Control_2 ANA:Sequential Tamoxifen and Anastrozole (change after registration, total 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
65 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1)Histologically proven invasive breast cancer, postoperative primary breast cancer, postmenopausal before registration (Postmenopausal is defined as (a)age>=60, (b)age>=45, amenorrhea more than 1 year without hysterectomy or (c)double ovariectomy has done. The case which is premenopausal before operation and menopaused after chemotherapy or during Tamoxifen administration will be included.)
(2)StageI,IIA,IIB,IIIA,IIIB (TNM staging system)
(3)(a)node dissection has done or (b) sentinel node biopsy has performed and diagnosis on H&E is negative
(4)The result of hormone receptor test meets (a)-(c). (a)estrogen receptor(+) and progesterone receptor(+),(b)estrogen receptor(+) and progesterone receptor(-),(c)estrogen receptor(-) and progesterone receptor(+) (Take priority over the result of immune staining to EIA)
(5)Taken Tamoxifen as postoperative adjuvant therapy for 1-4 years (need good compliance of patient)
(6)PS(ECOG) 0,1
(7)The results of tests below within last 6 months indicate no relapse and no contralateral breast cancer. (a)X-ray photo or CT of the breast,(b)Ultrasonography or CT of the abdomen,(c)Scintigraphy or X-ray photo of bone(thoracic vertebrae, lumbar vertebrae, pelvis and the other parts of paining),(d)Mammography of both side
(8)Relations to other treatments are (a)postoperative adjuvant treatment(chemotherapy or endocrinotherapy) is started within 12 weeks after mastectomy/ breast-conserving surgery,(b)postoperative chemotherapy finished till registration,(c)only Tamoxifen is permitted as pre-operative endocrinotherapy (pre-operative chemotherapy is permitted)
(9)WBC>3,000, PLT>100,000, Hb>=9.0, T-B=<1.5, GOT,GPT=<(every institution's reference value)*2.5, CRE=<1.5 (these values are tested within 8 weeks before registration), no past cardiac infraction or congestive heart failure, no ischemic heart disease or valvular disease needed to be treated
(10)Written informed consent
Key exclusion criteria (1)Invasive carcinoma of other organs (less than 5years after the last treatment)
(2)Metachronous or synchronous bilateral breast cancer
(3)Past deep venous embolism
(4)Osteoporosis needed to be treated or past bone fracture because of osteoporosis
(5)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 Tomohiko Aihara
Organization Aihara Hospital
Division name Department of Breast
Zip code
Address 3-3-20, Makiochi, Minoo-shi, Osaka, 562-0004, Japan
TEL 072-723-9001
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, 169-0051 JAPAN
TEL 03-5287-2633
Homepage URL http://www.csp.or.jp/
Email support@csp.or.jp

Sponsor
Institute N-SAS BC 03 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

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 12 Day

Related information
URL releasing protocol http://www.csp.or.jp/
Publication of results Partially published

Result
URL related to results and publications http://www.springerlink.com/content/20751q2755g2n641/
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 Completed
Date of protocol fixation
2002 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2002 Year 11 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 08 Month 12 Day
Last modified on
2016 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000046

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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