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

NCT00322348 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2011-01-24

Study results available
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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

Interventions

DRUG

Goserelin acetate

3.6 mg intramuscular depot injection given every 4 weeks

DRUG

Goserelin acetate

10.8 mg intramuscular depot injection given every 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Breast Cancer Established Brands Team Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Completion
2009-11-30

Countries

  • Czechia
  • Russia
  • Ukraine

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322348 on ClinicalTrials.gov