Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women

NCT ID: NCT00322348

Last Updated: 2011-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-11-30

Brief Summary

The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks.

Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of goserelin plasma concentration time profiles

Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZOLADEX 10.8 mg

ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks

Group Type: EXPERIMENTAL

Goserelin acetate

Intervention Type: DRUG

10.8 mg intramuscular depot injection given every 12 weeks

ZOLADEX 3.6 mg

ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks

Group Type: EXPERIMENTAL

Goserelin acetate

Intervention Type: DRUG

3.6 mg intramuscular depot injection given every 4 weeks

Interventions

Goserelin acetate

3.6 mg intramuscular depot injection given every 4 weeks

Intervention Type: DRUG

Goserelin acetate

10.8 mg intramuscular depot injection given every 12 weeks

Intervention Type: DRUG

Other Intervention Names

Zoladex®; Zoladex®

Eligibility Criteria

Inclusion Criteria

• Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
• World Health Organization (WHO) performance status of 0, 1, or 2
• Provided written informed consent

Exclusion Criteria

• Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
• Received radiotherapy within the past 4 weeks
• History of systemic malignancy other than breast cancer within the previous 3 years
• Estimated survival less than 24 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

Breast Cancer Established Brands Team Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Prague, , Czechia

Research Site

Arkhangelsk, , Russia

Research Site

Belgorod, , Russia

Research Site

Kaliningarad, , Russia

Research Site

Kazan, Tatarstan, , Russia

Research Site

Moscow, , Russia

Research Site

Ryazan, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Yaroslavl, , Russia

Research Site

Dnipropetrovsk, , Ukraine

Research Site

Donetsk, , Ukraine

Research Site

Kharkiv, , Ukraine

Research Site

Odesa, , Ukraine

Research Site

Uzhhorod, , Ukraine

Countries

Czechia; Russia; Ukraine

Other Identifiers

Zoladex ABC Study

Identifier Type: -

Identifier Source: secondary_id

D8664C00008

Identifier Type: -

Identifier Source: org_study_id