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
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
Status | Completed |
Enrollment | 98 |
Est. completion date | November 2009 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Czech Republic, Russian Federation, Ukraine,
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 |
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