Trial Outcomes & Findings for Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer (NCT NCT01073865)
NCT ID: NCT01073865
Last Updated: 2018-12-12
Results Overview
A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
24 weeks after the first dosing
Results posted on
2018-12-12
Participant Flow
Totally 286 patients were screened to the study from 58 centres in the following 6 countries: India, Japan, Korea, Philippines, Thailand, Taiwan. The first patient entered the study on 26 February 2010 and the last visit of last patient was on 19 September 2012.
286 patients were screened and 222 patients were randomized (109 in ZOLADEX 10.8 mg, 113 in ZOLADEX 3.6 mg)
Participant milestones
| Measure |
Zoladex 10.8 mg
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
113
|
|
Overall Study
Received Randomised Treatment
|
108
|
113
|
|
Overall Study
COMPLETED
|
81
|
74
|
|
Overall Study
NOT COMPLETED
|
28
|
39
|
Reasons for withdrawal
| Measure |
Zoladex 10.8 mg
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Overall Study
Reasons other than below
|
19
|
31
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
Baseline Characteristics
Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Zoladex 10.8 mg
n=109 Participants
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
n=113 Participants
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
109 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Asia · India
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
Asia · Japan
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
Asia · Philippines
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Asia · Thailand
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Asia · Taiwan
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Asia · Republic of Korea
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after the first dosingPopulation: Full Analysis Set
A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.
Outcome measures
| Measure |
Zoladex 10.8 mg
n=109 Participants
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
n=113 Participants
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
|
67 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after the first dosingPopulation: Full Analysis Set (patients without measurable disease at baseline were excluded from analysis)
Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.
Outcome measures
| Measure |
Zoladex 10.8 mg
n=88 Participants
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
n=93 Participants
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Number of Responders at 24 Weeks
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after the first dosingPopulation: Full Analysis Set
E2 serum concentrations (pg/mL) at 24 weeks
Outcome measures
| Measure |
Zoladex 10.8 mg
n=74 Participants
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
n=70 Participants
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Oestradiol (E2) Serum Concentrations at 24 Weeks
|
20.302 pg/mL
Standard Deviation 12.251
|
24.798 pg/mL
Standard Deviation 28.149
|
Adverse Events
Zoladex 10.8 mg
Serious events: 4 serious events
Other events: 47 other events
Deaths: 4 deaths
Zoladex 3.6 mg
Serious events: 8 serious events
Other events: 52 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Zoladex 10.8 mg
n=108 participants at risk
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
n=113 participants at risk
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
2.7%
3/113 • Number of events 3 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.93%
1/108 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Infections and infestations
TETANUS
|
0.93%
1/108 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.00%
0/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.93%
1/108 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.00%
0/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
General disorders
CHEST PAIN
|
0.93%
1/108 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.00%
0/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
0.88%
1/113 • Number of events 1 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
Other adverse events
| Measure |
Zoladex 10.8 mg
n=108 participants at risk
ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
|
Zoladex 3.6 mg
n=113 participants at risk
ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
|
|---|---|---|
|
Vascular disorders
HOT FLUSH
|
13.9%
15/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
19.5%
22/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Infections and infestations
NASOPHARYNGITIS
|
12.0%
13/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
8.0%
9/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.6%
5/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
8.0%
9/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Nervous system disorders
HEADACHE
|
6.5%
7/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
6.2%
7/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Gastrointestinal disorders
NAUSEA
|
1.9%
2/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
8.0%
9/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.7%
4/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
4.4%
5/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Gastrointestinal disorders
VOMITING
|
3.7%
4/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
2.7%
3/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.93%
1/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
3.5%
4/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.8%
3/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
4.4%
5/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
General disorders
PYREXIA
|
1.9%
2/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
6.2%
7/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
General disorders
FATIGUE
|
0.93%
1/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
3.5%
4/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Psychiatric disorders
INSOMNIA
|
2.8%
3/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
5.3%
6/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.8%
3/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
3.5%
4/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.7%
4/108 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
3.5%
4/113 • Non serious AEs and SAEs were be collected from the time of patient informed until 4 weeks after the final administration of ZOLADEX 3.6 mg or 12 weeks after the final administration of ZOLADEX 10.8 mg
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs cannot disclose trial results without prior approval in writing by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER