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Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients

NCT ID: NCT00303524

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-02-28

Brief Summary

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The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Zoladex 3-month depot

Group Type EXPERIMENTAL

Goserelin acetate

Intervention Type DRUG

injection 10.8 mg every 3 months

2

Zoladex 1-month depot

Group Type EXPERIMENTAL

Goserelin acetate

Intervention Type DRUG

Injection 3.6 mg monthly

Interventions

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Goserelin acetate

Injection 3.6 mg monthly

Intervention Type DRUG

Goserelin acetate

injection 10.8 mg every 3 months

Intervention Type DRUG

Other Intervention Names

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Zoladex Zoladex

Eligibility Criteria

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Inclusion Criteria

* Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2.

Exclusion Criteria

* Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Japan Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Chiba, , Japan

Site Status

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Fukuoka, , Japan

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Fukushima, , Japan

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Isehara, , Japan

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Kagoshima, , Japan

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Kashiwa, , Japan

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Kawasaki, , Japan

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Kitakyushu, , Japan

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Kumamoto, , Japan

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Matsuyama, , Japan

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Miyazaki, , Japan

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Nagoya, , Japan

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Niigata, , Japan

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Osaka, , Japan

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Ōta-ku, , Japan

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Saitama, , Japan

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Sayama, , Japan

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Shimotsuke, , Japan

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Suita, , Japan

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Tokorozawa, , Japan

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Tokyo, , Japan

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Utsunomiya, , Japan

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Countries

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Japan

Other Identifiers

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Zoladex EBC Study

Identifier Type: -

Identifier Source: secondary_id

D8664C00004

Identifier Type: -

Identifier Source: org_study_id