Trial Outcomes & Findings for Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer" (NCT NCT03209518)
NCT ID: NCT03209518
Last Updated: 2019-11-01
Results Overview
Recruitment status
COMPLETED
Target enrollment
312 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2019-11-01
Participant Flow
Participants took part in the survey at 52 investigative sites in Japan, from 18 March 2016 to 10 October 2018.
Participants with a historical diagnosis of premenopausal breast cancer were enrolled. Participants received Leuprorelin as part of routine medical care.
Participant milestones
| Measure |
Leuprorelin Acetate 22.5 mg
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
|
|---|---|
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Overall Study
STARTED
|
312
|
|
Overall Study
COMPLETED
|
310
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Leuprorelin Acetate 22.5 mg
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
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|---|---|
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Overall Study
Case Report Forms Uncollected
|
1
|
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Overall Study
Protocol Deviation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Leuprorelin Acetate 22.5 mg
n=310 Participants
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
|
|---|---|
|
Age, Continuous
|
43.8 Years
STANDARD_DEVIATION 5.36 • n=310 Participants
|
|
Sex: Female, Male
Female
|
310 Participants
n=310 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=310 Participants
|
|
Region of Enrollment
Japan
|
310 Participants
n=310 Participants
|
|
Duration between Diagnosis of Premenopausal Breast Cancer and Survey Start
|
23.80 Months
STANDARD_DEVIATION 20.777 • n=310 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
302 Participants
n=310 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
8 Participants
n=310 Participants
|
|
Target of Treatment
Participants with Neoadjuvant Therapy
|
14 Participants
n=310 Participants
|
|
Target of Treatment
Participants with Adjuvant Therapy
|
272 Participants
n=310 Participants
|
|
Target of Treatment
Participants with Progressive Breast Cancer
|
12 Participants
n=310 Participants
|
|
Target of Treatment
Participants with Recurrent Breast Cancer
|
12 Participants
n=310 Participants
|
|
Number of Participants with Hormone Receptor Expression
|
310 Participants
n=310 Participants
|
|
Healthcare Category
Outpatient
|
308 Participants
n=310 Participants
|
|
Healthcare Category
Inpatient
|
2 Participants
n=310 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
282 Participants
n=310 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
26 Participants
n=310 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
2 Participants
n=310 Participants
|
|
Medical Complications
Had No Medical Complications
|
267 Participants
n=310 Participants
|
|
Medical Complications
Had Medical Complications
|
43 Participants
n=310 Participants
|
|
Medical History of Thromboembolism
Had No Medical History of Thromboembolism
|
307 Participants
n=310 Participants
|
|
Medical History of Thromboembolism
Had Medical History of Thromboembolism
|
3 Participants
n=310 Participants
|
|
Height
|
159.4 Centimeters (cm)
STANDARD_DEVIATION 5.26 • n=290 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
55.55 Kilograms (kg)
STANDARD_DEVIATION 10.650 • n=290 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
21.86 kg/meter(m)^2
STANDARD_DEVIATION 3.952 • n=289 Participants • The number analyzed is the number of participants with data available for analysis.
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|
Prior Treatment with LH-RH Agonists
Not Treated with Drugs
|
77 Participants
n=310 Participants
|
|
Prior Treatment with LH-RH Agonists
Treated with LH-RH Agonists
|
233 Participants
n=310 Participants
|
|
Prior Treatment with Drugs for Premenopausal Breast Cancer
Not Treated with Drugs
|
47 Participants
n=310 Participants
|
|
Prior Treatment with Drugs for Premenopausal Breast Cancer
Treated with Drugs
|
263 Participants
n=310 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.
Outcome measures
| Measure |
Leuprorelin Acetate 22.5 mg
n=310 Participants
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
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|---|---|
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Percentage of Participants Who Had One or More Adverse Events
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6.45 Percentage of Participants
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SECONDARY outcome
Timeframe: Up to Week 24Population: Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.
Adverse drug reaction refers to adverse events related to the administered drug.
Outcome measures
| Measure |
Leuprorelin Acetate 22.5 mg
n=310 Participants
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
|
|---|---|
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Percentage of Participants Who Had One or More Adverse Reactions
|
5.48 Percentage of Participants
|
Adverse Events
Leuprorelin Acetate 22.5 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Leuprorelin Acetate 22.5 mg
n=310 participants at risk
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
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|---|---|
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Vascular disorders
Hot flush
|
0.97%
3/310 • Up to Week 24
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
2/310 • Up to Week 24
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to survey treatment.
|
|
General disorders
Injection site induration
|
1.3%
4/310 • Up to Week 24
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to survey treatment.
|
|
General disorders
Injection site pain
|
2.9%
9/310 • Up to Week 24
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to survey treatment.
|
|
General disorders
Injection site pruritus
|
0.65%
2/310 • Up to Week 24
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to survey treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER