Premenopausal Breast Cancer
Conditions
Brief summary
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
Detailed description
The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer. This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting. The survey will enroll approximately 300 patients. \- Leuprorelin This multi-center survey will be conducted in Japan.
Interventions
DRUGLeuprorelin acetate
Leuplin PRO for Injection Kit 22.5 mg
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
\- Participants with premenopausal breast cancer will be included.
Exclusion criteria
* Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues * Pregnant or potentially pregnant participants and breastfeeding participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Reactions | Up to Week 24 | Adverse drug reaction refers to adverse events related to the administered drug. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 52 investigative sites in Japan, from 18 March 2016 to 10 October 2018.
Pre-assignment details
Participants with a historical diagnosis of premenopausal breast cancer were enrolled. Participants received Leuprorelin as part of routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 310 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 1 |
| Overall Study | Protocol Deviation | 1 |
Baseline characteristics
| Characteristic | Leuprorelin Acetate 22.5 mg | — |
|---|---|---|
| Age, Continuous | 43.8 Years STANDARD_DEVIATION 5.36 | — |
| BMI | 21.86 kg/meter(m)^2 STANDARD_DEVIATION 3.952 | — |
| Duration between Diagnosis of Premenopausal Breast Cancer and Survey Start | 23.80 Months STANDARD_DEVIATION 20.777 | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 302 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 8 Participants | — |
| Healthcare Category Inpatient | 2 Participants | — |
| Healthcare Category Outpatient | 308 Participants | — |
| Height | 159.4 Centimeters (cm) STANDARD_DEVIATION 5.26 | — |
| Medical Complications Had Medical Complications | 43 Participants | — |
| Medical Complications Had No Medical Complications | 267 Participants | — |
| Medical History of Thromboembolism Had Medical History of Thromboembolism | 3 Participants | — |
| Medical History of Thromboembolism Had No Medical History of Thromboembolism | 307 Participants | — |
| Number of Participants with Hormone Receptor Expression | 310 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 282 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 26 Participants | — |
| Predisposition to Hypersensitivity Unknown | 2 Participants | — |
| Prior Treatment with Drugs for Premenopausal Breast Cancer Not Treated with Drugs | 47 Participants | — |
| Prior Treatment with Drugs for Premenopausal Breast Cancer Treated with Drugs | 263 Participants | — |
| Prior Treatment with LH-RH Agonists Not Treated with Drugs | 77 Participants | — |
| Prior Treatment with LH-RH Agonists Treated with LH-RH Agonists | 233 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 310 Participants | — |
| Sex: Female, Male Female | 310 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| Target of Treatment Participants with Adjuvant Therapy | 272 Participants | — |
| Target of Treatment Participants with Neoadjuvant Therapy | 14 Participants | — |
| Target of Treatment Participants with Progressive Breast Cancer | 12 Participants | — |
| Target of Treatment Participants with Recurrent Breast Cancer | 12 Participants | — |
| Weight | 55.55 Kilograms (kg) STANDARD_DEVIATION 10.65 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 310 |
| other Total, other adverse events | 20 / 310 |
| serious Total, serious adverse events | 0 / 310 |
Outcome results
Primary
Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Leuprorelin Acetate 22.5 mg | Percentage of Participants Who Had One or More Adverse Events | 6.45 Percentage of Participants |
Secondary
Percentage of Participants Who Had One or More Adverse Reactions
Adverse drug reaction refers to adverse events related to the administered drug.
Time frame: Up to Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Leuprorelin Acetate 22.5 mg | Percentage of Participants Who Had One or More Adverse Reactions | 5.48 Percentage of Participants |