Trial · Interventional
CompletedPhase 2Results postedRegistry dataCzechia, Russia, Ukraine
1 trial · 1 completed · 1 with posted results
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
NCT00322348Apr 2006 to Nov 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Experimental
ZOLADEX 10.8 mg
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
Experimental
ZOLADEX 3.6 mg
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Outcomes the sponsor listed as primary.
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).
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 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.
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
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
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
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
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)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of participants) |
|---|---|
| ZOLADEX 10.8 mg | 69.4 |
| ZOLADEX 3.6 mg | 73.5 |
| Group | Value (Percentage of participants) |
|---|---|
| ZOLADEX 10.8 mg | 28.9 |
| ZOLADEX 3.6 mg | 25.6 |
| Group | Value (pmol/L) | Spread |
|---|---|---|
| ZOLADEX 10.8 mg | 1.42 | 0.99 |
| ZOLADEX 3.6 mg | 1.49 | 0.99 |
| Group | Value (ng/mL) |
|---|---|
| ZOLADEX 10.8 mg | 4.565 |
| ZOLADEX 3.6 mg | not posted |
| Group | Value (hours) |
|---|---|
| ZOLADEX 10.8 mg | 1.9 |
| ZOLADEX 3.6 mg | not posted |
| Group | Value (ng/mL) |
|---|---|
| ZOLADEX 10.8 mg | 33.021 |
| ZOLADEX 3.6 mg | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ZOLADEX 10.8 mgZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks | – | 2 / 50 | 39 / 50 |
| ZOLADEX 3.6 mgZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks | – | 3 / 48 | 37 / 48 |
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