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Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

NCT ID: NCT00605267

Last Updated: 2012-09-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast Cancer Breast Neoplasms Tumors or cancer of the human BREAST Tumor or cancer of the human MAMMARY GLAND

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Tamoxifen

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20 mg once daily oral dose

Goserelin acetate (Zoladex)

Intervention Type DRUG

3.6mg/month depot injection

2

Anastrazole (Arimidex)

Group Type EXPERIMENTAL

Anastrazole (Arimidex)

Intervention Type DRUG

1 mg once daily oral dose

Goserelin acetate (Zoladex)

Intervention Type DRUG

3.6mg/month depot injection

Interventions

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Tamoxifen

20 mg once daily oral dose

Intervention Type DRUG

Anastrazole (Arimidex)

1 mg once daily oral dose

Intervention Type DRUG

Goserelin acetate (Zoladex)

3.6mg/month depot injection

Intervention Type DRUG

Other Intervention Names

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NOLVADEX ARIMIDEX ZD1033 ZOLADEX

Eligibility Criteria

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Inclusion Criteria

* Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided 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).
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshiyuki Kihara

Role: STUDY_DIRECTOR

Clinical

Locations

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Research Site

Hakata, Fukuoka, Japan

Site Status

Research Site

Kumamoto, Kumamoto, Japan

Site Status

Research Site

Nagoya, Nagoya, Japan

Site Status

Research Site

Osaka, Osaka, Japan

Site Status

Countries

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Japan

References

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Masuda N, Sagara Y, Kinoshita T, Iwata H, Nakamura S, Yanagita Y, Nishimura R, Iwase H, Kamigaki S, Takei H, Noguchi S. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. 2012 Apr;13(4):345-52. doi: 10.1016/S1470-2045(11)70373-4. Epub 2012 Jan 20.

Reference Type DERIVED
PMID: 22265697 (View on PubMed)

Other Identifiers

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D539BC00001

Identifier Type: -

Identifier Source: org_study_id