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

An Open-label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

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

Study Overview

• Status: Completed
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Goserelin acetate; Drug: Goserelin acetate

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czech Republic
  • Praha 8, Czech Republic
    • Research Site
• Russian Federation
  • Arkhangelsk, Russian Federation
    • Research Site
  • Belgorod, Russian Federation
    • Research Site
  • Kaliningarad, Russian Federation
    • Research Site
  • Kazan, Tatarstan, Russian Federation
    • Research Site
  • Moscow, Russian Federation
    • Research Site
  • Ryazan, Russian Federation
    • Research Site
  • St Petersburg, Russian Federation
    • Research Site
  • St-petersburg, Russian Federation
    • Research Site
  • Yaroslavl, Russian Federation
    • Research Site
• Ukraine
  • Dnipropetrovsk, Ukraine
    • Research Site
  • Donetsk, Ukraine
    • Research Site
  • Kharkiv, Ukraine
    • Research Site
  • Odessa, Ukraine
    • Research Site
  • Uzhgorod, Ukraine
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZOLADEX 10.8 mg; ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks	Drug: Goserelin acetate; 3.6 mg intramuscular depot injection given every 4 weeks; Other Names: Zoladex®; Drug: Goserelin acetate; 10.8 mg intramuscular depot injection given every 12 weeks; Other Names: Zoladex®
Experimental: ZOLADEX 3.6 mg; ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks	Drug: Goserelin acetate; 3.6 mg intramuscular depot injection given every 4 weeks; Other Names: Zoladex®; Drug: Goserelin acetate; 10.8 mg intramuscular depot injection given every 12 weeks; Other Names: Zoladex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Progression Free Survival (PFS) at Week 24	The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.	Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) at Week 24	Number of participants who were objective responders at Week 24 over the number of participants evaluable for response x 100. An objective responder = a participants whose best unconfirmed response is either CR (Complete Response Disappearance of all target lesions) or PR (Partial Response At least a 30% decrease in target lesions)	Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.
Oestradiol (E2) Serum Concentrations at Week 24	A comparison of mean E2 serum concentrations at timepoint(s) post Day 1 performed using analysis of covariance (ANCOVA), with treatment group, baseline E2 serum concentrations and country as covariates. Data analysed on the log scale; log scale mean and pooled log scale standard deviation from Analysis of Covariance (ANCOVA) presented.	Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presented
Maximum Plasma Concentration, Cmax (ng/mL)	Maximum plasma concentration, Cmax (ng/mL), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)	Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup
Time to Maximum Plasma Concentration, Tmax (Hours)	Time to maximum plasma concentration, Tmax (hours), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)	Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup
Area Under the Plasma Concentration Curve (0-12 Weeks)	Area under the plasma concentration curve (0-12 weeks) derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)	Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Breast Cancer Established Brands Team Medical Science Director, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: May 3, 2006
• First Submitted That Met QC Criteria: May 3, 2006
• First Posted (Estimate): May 5, 2006

Study Record Updates

• Last Update Posted (Estimate): January 24, 2011
• Last Update Submitted That Met QC Criteria: December 22, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: breast cancer; cancer; oncology
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Goserelin
• Other Study ID Numbers: D8664C00008; Zoladex ABC Study