Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female

Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of >= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.

Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.

Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.