Breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Leuplin SR 11.25 mg for Injection (leuprorelin acetate)
INN of investigational material :
Therapeutic category code : 249 Other hormone preparations (in
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy).
Exclusion criteria
Exclusion criteria: Patients with a history of treatment with Leuplin SR 11.25 mg for Injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframe: For 96 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| [1] Antitumor efficacy and time to progression over the 96-week period of treatment with Leuplin SR 11.25 mg for Injection in patients with advanced or recurrent breast cancer [2] Recurrence-free survival and time to recurrence over the 96-week period of treatment with Leuplin SR 11.25 mg for Injection in patients who were treated asadjuvant therapy Secondary timeframe: From baseline to 96 weeks of treatment [1] For patients with advanced or recurrent breast cancer, the antitumor efficacy (best response) of Leuplin SR 11.25 mg for Injection will be evaluated. In addition, time to progression will be determined and tabulated, based on the date progressive disease, the presence or absence of progressive disease, continued survival or death, and the date of death. [2] For patients who were treated asadjuvant therapy, recurrence-free survival and time to recurrence will be determined and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death. | — |
Outcome results
None listed