UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000057
Receipt number R000000053
Scientific Title Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients
Date of disclosure of the study information 2005/08/12
Last modified on 2016/02/19 14:38:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer Patients

Acronym

Phase III Randomized Adjuvant Study in Hormone-Responsive Postmenopausal Breast Cancer Patients (N-SAS BC 04)

Scientific Title

Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen 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 04)

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 of effect among Tamoxifen followed by Exemestane, Anastrozole and Exemestane on bone mineral content and lipid, especially (1)equivalency of Exemestane and Anastrozole to Tamoxifen followed by Exemestane (2)difference between Anasorozole and Exemestane

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Relapse-Free Survival after a lapse of 2.5-3 years
Quantity of lipid metabolic
Bone mineral content

Key secondary outcomes

Relapse-Free Survival after a lapse of 5 years
Overall Survival
Rate of contralateral breat cancer
Adverse events
Long-term tolerance
Function of blood coagulation and fibrinolysis
Health Related QOL


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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

EXE : Exemestane for 5 years

Interventions/Control_2

TAM : Tamoxifen for 2.5-3 years followed by Exemestane for 2.5-3 years (control)

Interventions/Control_3

ANA : Anastrozole for 5 years

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

(1)Histologically proven invasive breast cancer which is postoperative primary breast cancer and postmenopausal before registration (postmenopausal is defined as (a)age>=60, (b)age>=45, amenorrhea more than 1year 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)Cases which meet one of the criteria (a)-(d) (a)diameter of invation>3cm, (b)pathologically node positive (pN+), (c)Nuclear Grade 3 by N-SAS BC Standard (in case of invasive lactiferous duct cancer), (d)invasive lobular carcinoma, epidermoid carcinoma or spindle cell carcinoma
(5)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)
(6)PS(ECOG) 0,1
(7)Relations to other treatments are (a)postoperative chemotherapy finished till registration for this study, (b)no pre-operative chemotherapy, (c)no pre- and post-operative hormonal therapy
(8)WBC>3,000, PLT>100,000, GOT,GPT=<(every institution's reference value)*2.5, CRE=<1.5( these values are examined within 4 weeks before registration for this study), no on-going treatment of cerebral embolism, no past cardiac infraction or congestive heart failure, no ischemic heart disease or valvular disease needed to be treated
(9)Reference values (a)lipid:total cholesterol(TC)<260mg/dl and total neutral lipid<300mg/dl (fasting blood sampling), (b)bone mineral content:more than 70% of average of young person (at only institutions which are able to collect data about bone)
(10)Written informed consent

Key exclusion criteria

(1)invasive carcinoma of other organs (less than 5 years after the last treatment)
(2)Past breast cancer
(3)Past deep venous embolism
(4)HRT(hormone replacement therapy) for symptoms of menopause within 4weeks before treatment
(5)Metachronous or synchronous bilateral breast cancer
(6)Patients judged inappropriate for this study by the physicians

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Hozumi

Organization

Jichi Medical School

Division name

Department of Mammary gland/General Surgery

Zip code


Address

3311-1, Yakushiji, Minamikouchi-cho, Kouchi-gun, Tochigi, 329-0498, Japan

TEL

0285-58-7371

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 or person

Institute

N-SAS BC 04 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


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

2003 Year 08 Month 29 Day

Date of IRB


Anticipated trial start date

2003 Year 09 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Core-protocol of this trial is of TEAM trial, which purposes comparison between Exemestane(EXE) and Tamoxifen(TAM). Sub-protocol (Japan original) additionally purposes assessment of secondary effects (lipid metabolic, bone mineral, function of blood coagulation and fibrinolysis) and Health Related QOL among EXE, TAM and ANA. EXE and TAM of Sub-protocol are registered for Core-protocol too.


Management information

Registered date

2005 Year 08 Month 12 Day

Last modified on

2016 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name