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

Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322348
• Other study ID #: D8664C00008
• Secondary ID: Zoladex ABC Stud
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2006
• Last updated: December 22, 2010
• Start date: April 2006
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines AgencyJapan: Ministry of Health, Labor and WelfareItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthUkraine: State Pharmacological Center - Ministry of HealthPoland: Ministry of HealthCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Goserelin acetate
3.6 mg intramuscular depot injection given every 4 weeks
• Goserelin acetate
10.8 mg intramuscular depot injection given every 12 weeks

Locations

Country	Name	City	State
Czech Republic	Research Site	Praha 8
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
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Uzhgorod

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Czech Republic,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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