Breast cancer
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Premenopausal breast cancer patients who meet all the following criteria are to be enrolled in the surveillance: [1] Patients who received 4 weeks of treatment with a repository LH-RHa preparation 1 month prior to administration of Leuplin SR 11.25 mg Injection Kit [2] Patients receiving Leuplin SR 11.25 mg Injection Kit as adjuvant therapy [3] Patients with performance status grade of 0 or 1 [4] Patients who answered all of the questions on the "QOL check sheet (I)" at the start (Week 0) of treatment with Leuplin SR 11.25 mg Injection Kit
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are to be excluded from the surveillance: [1] Patients with a history of hypersensitivity to ingredient(s) in Leuplin SR 11.25 mg Injection Kit or synthetic derivatives of LH-RH or LH-RH [2] Pregnant women, possibly pregnant women, and nursing mothers [3] Patients with advanced (T4 or M1 according to the TNM classification [General Rules for Clinical and Pathological Recording of Breast Cancer: 16th edition]) or recurrent breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL survey and convenience Primary timeframeFrom baseline to 48 weeks of treatment For the efficacy analysis set, the following parameters will be tabulated: Total QOL-ACD score, total QOL-ACD-B score, and answers to each question on the QOL survey following switching medication will be tabulated at each survey time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Secondary timeframeFor 48 weeks The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of leuprorelin acetate whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with leuprorelin acetate are defined as adverse drug reactions. | — |
Outcome results
None listed