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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Breast Cancer
Intervention Drug: Goserelin acetate
Enrollment 98
Recruitment Details Pre-menopausal women with Oestrogen Receptor Positive Advanced Breast Cancer were recruited between 25th April 2006 and 24th December 2007. 49 participants were randomised to ZOLADEX 10.8 mg and 49 participants were randomised to ZOLADEX 3.6 mg. One participant was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg.
Pre-assignment Details 53 of the151 screened participants were not randomised to treatment groups for the following reasons : 50 participants were incorrectly enrolled (i.e. did not comply with inclusions/exclusion criteria) and a bone scan was not performed for 3 participants.
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Period Title: Overall Study
Started 49 49
Received Study Treatment 50 48
Completed 12 [1] 16 [1]
Not Completed 37 33
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             1             4
Lost to Follow-up             1             0
Death             0             2
Disease Progression             30             25
Reasons not specified             5             1
[1]
Number of participants completed up to Week 96
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg Total
Hide Arm/Group Description ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 49 49 98
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 49 participants 98 participants
42.0  (6.45) 42.6  (6.07) 42.3  (6.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Female
49
 100.0%
49
 100.0%
98
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Caucasian 27 32 59
Black 0 0 0
Oriental 22 17 39
Other 0 0 0
1.Primary Outcome
Title Percentage of Participants With Progression Free Survival (PFS) at Week 24
Hide Description 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.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description:
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Overall Number of Participants Analyzed 49 49
Measure Type: Number
Unit of Measure: Percentage of participants
69.4 73.5
2.Secondary Outcome
Title Objective Response Rate (ORR) at Week 24
Hide Description 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)
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description:
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Overall Number of Participants Analyzed 45 43
Measure Type: Number
Unit of Measure: Percentage of participants
28.9 25.6
3.Secondary Outcome
Title Oestradiol (E2) Serum Concentrations at Week 24
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description:
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Overall Number of Participants Analyzed 41 45
Log Mean (Standard Deviation)
Unit of Measure: pmol/L
1.42  (0.99) 1.49  (0.99)
4.Secondary Outcome
Title Maximum Plasma Concentration, Cmax (ng/mL)
Hide Description 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
participants in the pharmacokinetic (PK) subgroup
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description:
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Overall Number of Participants Analyzed 19 0
Geometric Mean (Full Range)
Unit of Measure: ng/mL
4.565
(0.501 to 14.000)
5.Secondary Outcome
Title Time to Maximum Plasma Concentration, Tmax (Hours)
Hide Description 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)
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
Hide Outcome Measure Data
Hide Analysis Population Description
participants in the PK subgroup set
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description:
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Overall Number of Participants Analyzed 19 0
Geometric Mean (Full Range)
Unit of Measure: hours
1.9
(1 to 24)
6.Secondary Outcome
Title Area Under the Plasma Concentration Curve (0-12 Weeks)
Hide Description 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)
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
Hide Outcome Measure Data
Hide Analysis Population Description
participants in the PK subgroup set
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description:
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Overall Number of Participants Analyzed 19 0
Geometric Mean (Full Range)
Unit of Measure: ng/mL
33.021
(9.13 to 73.70)
Time Frame [Not Specified]
Adverse Event Reporting Description 49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
 
Arm/Group Title ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Hide Arm/Group Description ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
All-Cause Mortality
ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/50 (4.00%)   3/48 (6.25%) 
Infections and infestations     
Peritonsillar Abscess  1  0/50 (0.00%)  1/48 (2.08%) 
Injury, poisoning and procedural complications     
Humerus Fracture  1  1/50 (2.00%)  0/48 (0.00%) 
Reproductive system and breast disorders     
Endometrial Hyperplasia  1  1/50 (2.00%)  1/48 (2.08%) 
Vascular disorders     
Haematoma  1  0/50 (0.00%)  1/48 (2.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZOLADEX 10.8 mg ZOLADEX 3.6 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   39/50 (78.00%)   37/48 (77.08%) 
Blood and lymphatic system disorders     
Anaemia  1  0/50 (0.00%)  3/48 (6.25%) 
Gastrointestinal disorders     
Nausea  1  3/50 (6.00%)  4/48 (8.33%) 
Abdominal Pain  1  0/50 (0.00%)  3/48 (6.25%) 
Vomiting  1  0/50 (0.00%)  3/48 (6.25%) 
General disorders     
Fatigue  1  0/50 (0.00%)  4/48 (8.33%) 
Pyrexia  1  1/50 (2.00%)  4/48 (8.33%) 
Asthenia  1  1/50 (2.00%)  3/48 (6.25%) 
Infections and infestations     
Nasopharyngitis  1  11/50 (22.00%)  5/48 (10.42%) 
Respiratory Tract Infection Viral  1  3/50 (6.00%)  2/48 (4.17%) 
Weight Increased  1  7/50 (14.00%)  8/48 (16.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/50 (4.00%)  4/48 (8.33%) 
Back Pain  1  1/50 (2.00%)  3/48 (6.25%) 
Nervous system disorders     
Headache  1  4/50 (8.00%)  3/48 (6.25%) 
Reproductive system and breast disorders     
Amenorrhoea  1  13/50 (26.00%)  11/48 (22.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/50 (0.00%)  4/48 (8.33%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/50 (0.00%)  3/48 (6.25%) 
Vascular disorders     
Hot Flush  1  19/50 (38.00%)  18/48 (37.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
The criteria for non-inferiority were not met for the primary efficacy endpoint (PFS at Week 24). However, since recruitment was terminated prematurely, the study was no longer adequately powered to detect non-inferiority.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
There is an agreement between the Principal Investigator and the Sponsor (or its agents). The only disclosure restriction on the PI is that they cannot disclose or publish any information to do with the trial without consent from AstraZeneca.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00322348    
Other Study ID Numbers: D8664C00008
Zoladex ABC Study
First Submitted: May 3, 2006
First Posted: May 5, 2006
Results First Submitted: November 11, 2010
Results First Posted: January 24, 2011
Last Update Posted: January 24, 2011