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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163203 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprorelin acetate | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprorelin acetate | Drug | Leuplin PRO for Injection Kit 22.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Up to Week 24 |
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Inclusion Criteria:
- Participants with premenopausal breast cancer will be included.
Exclusion Criteria:
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The survey population will consist of participants with a diagnosis of premenopausal breast cancer and received dose of Leuprorelin for Injection Kit 22.5 mg in the routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda selected site | Tokyo | Japan |
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants with a historical diagnosis of premenopausal breast cancer were enrolled. Participants received Leuprorelin as part of routine medical care.
Participants took part in the survey at 52 investigative sites in Japan, from 18 March 2016 to 10 October 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Had One or More Adverse Events | 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. | Posted | Number | Percentage of Participants | Up to Week 24 |
|
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | MedDRA Ver. 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2019 | Oct 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2019 | Oct 9, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Duration between Diagnosis of Premenopausal Breast Cancer and Survey Start | Mean duration between the first diagnosis of premenopausal breast cancer and the start of the survey was reported. | Mean | Standard Deviation | Months |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Number of participants with each score of ECOG Performance Status at the survey start was reported. Following are ECOG grades. 0:Fully active, perform all pre-disease activities without restriction. 1:Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2:Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3:Capable of limited self-care, confined to bed or chair >50% of waking hours. 4:Completely disabled, not capable of any self-care, totally confined to bed or chair. | Count of Participants | Participants |
|
| Target of Treatment | Count of Participants | Participants |
|
| Number of Participants with Hormone Receptor Expression | Count of Participants | Participants |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | Number of participants who had or did not have a liability or tendency to suffer from hypersensitivity was reported. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Medical History of Thromboembolism | Number of participants with or without medical history of thromboembolism was reported. | Count of Participants | Participants |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | kg/meter(m)^2 |
|
| Prior Treatment with LH-RH Agonists | Number of participants who were treated or were not treated with LH-RH agonists for premenopausal breast cancer was reported. | Count of Participants | Participants |
|
| Prior Treatment with Drugs for Premenopausal Breast Cancer | Number of participants who were treated or were not treated with drugs except LH-RH agonists for premenopausal breast cancer was reported. | Count of Participants | Participants |
|
|
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| Secondary | Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | 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. | Posted | Number | Percentage of Participants | Up to Week 24 |
|
|
|
| 0 |
| 310 |
| 0 |
| 310 |
| 20 |
| 310 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA Ver. 21.1 | Systematic Assessment |
|
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.
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |