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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00322348
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : January 24, 2011
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE May 3, 2006
First Posted Date  ICMJE May 5, 2006
Results First Submitted Date  ICMJE November 11, 2010
Results First Posted Date  ICMJE January 24, 2011
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2006)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2006)
  • Provide supporting data confirming Zoladex 10.8mg/12weeks is non-inferior to Zoladex 3.8mg/4 weeks
  • Compare safety and tolerability of both doses
  • Assess goserelin PK in Japanese and non-Japanese patients who have received Zoladex 10.8mg
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
Official Title  ICMJE 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
Brief 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Breast Cancer
Intervention  ICMJE
  • Drug: Goserelin acetate
    3.6 mg intramuscular depot injection given every 4 weeks
    Other Name: Zoladex®
  • Drug: Goserelin acetate
    10.8 mg intramuscular depot injection given every 12 weeks
    Other Name: Zoladex®
Study Arms  ICMJE
  • Experimental: ZOLADEX 10.8 mg
    ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
    Intervention: Drug: Goserelin acetate
  • Experimental: ZOLADEX 3.6 mg
    ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
    Intervention: Drug: Goserelin acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2009)
98
Original Enrollment  ICMJE
 (submitted: May 3, 2006)
260
Actual Study Completion Date  ICMJE November 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Russian Federation,   Ukraine
Removed Location Countries Italy,   Japan,   Poland,   Romania
 
Administrative Information
NCT Number  ICMJE NCT00322348
Other Study ID Numbers  ICMJE D8664C00008
Zoladex ABC Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Breast Cancer Established Brands Team Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP