臨床研究等提出・公開システム

Date of registration	Mar. 25, 2008
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220535

Scientific Title	Multi-Centre, Randomised, Double-Blind, Parallel-Group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-Operative Administration Under Luteinising Hormone-Releasing Hormone Agonist Treatment for Premenopausal Breast Cancer Patients
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	RD-clinical-information-Japan@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, Double Blind, Active Control, Parallel Assignment Study
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Ages Eligible for Study: 20 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Inclusion Criteria: -Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provide written informed consent Exclusion Criteria: -Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Female
Health Condition or Problem Studied		Breast Cancer
Intervention(s)		investigational material(s) Generic name etc : Tamoxifen \| Anastrazole (Arimidex) \| Goserelin acetate (Zoladex) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Tamoxifen: Oral, Anastrazole: Oral, Goserelin acetate: Injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety/Efficacy Primary Outcome Measures: -The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group, during 24 weeks pre-operative administration, for premenopausal breast cancer patients receiving Zoladex 3.6mg/month [ Time Frame: Assessed after 24 weeks of treatment ] [ Designated as safety issue: No ]Secondary Outcome Measures: -Safety of anastrozole and tamoxifen groups by: adverse events, lab. tests, blood pressure, pulse rate, WHO performance status and change in bone mineral density and bone turnover markers. Additional efficacy markers [ Time Frame: Assessed after 24 weeks of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome

Primary Sponsor	AstraZeneca
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-080557
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 16, 2016	Detail	Changes
7	Dec. 16, 2016	Detail	Changes
6	July. 20, 2012	Detail	Changes
5	July. 20, 2012	Detail	Changes
4	Feb. 08, 2010	Detail	Changes
3	Feb. 08, 2010	Detail	Changes
2	Mar. 25, 2008	Detail	Changes
1	Mar. 25, 2008	Detail

List of change history