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

Purpose

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

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Goserelin acetate	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause

Drug Information available for: Goserelin Goserelin acetate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percentage of Participants With Progression Free Survival (PFS) at Week 24 [ Time Frame: 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). ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Objective Response Rate (ORR) at Week 24 [ Time Frame: 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. ] [ Designated as safety issue: No ]
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)
Oestradiol (E2) Serum Concentrations at Week 24 [ Time Frame: 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 ] [ Designated as safety issue: No ]
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.
Maximum Plasma Concentration, Cmax (ng/mL) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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)
Time to Maximum Plasma Concentration, Tmax (Hours) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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)
Area Under the Plasma Concentration Curve (0-12 Weeks) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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)

Enrollment:	98
Study Start Date:	April 2006
Study Completion Date:	November 2009

Arms	Assigned Interventions
Experimental: ZOLADEX 10.8 mg ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks	Drug: Goserelin acetate 10.8 mg intramuscular depot injection given every 12 weeks Other Name: 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 Name: Zoladex®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322348

Locations

Czech Republic
Research Site
Praha 8, Czech Republic
Russian Federation
Research Site
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
Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kharkiv, Ukraine
Research Site
Odessa, Ukraine
Research Site
Uzhgorod, Ukraine

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Breast Cancer Established Brands Team Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00322348 History of Changes
Other Study ID Numbers:	D8664C00008, Zoladex ABC Study
Study First Received:	May 3, 2006
Results First Received:	November 11, 2010
Last Updated:	December 22, 2010
Health Authority:	Romania: National Medicines Agency Japan: Ministry of Health, Labor and Welfare Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Russia: Pharmacological Committee, Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health Poland: Ministry of Health Czech Republic: State Institute for Drug Control

Keywords provided by AstraZeneca:

oncology
cancer
breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013