Conditions: Premenopausal Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 167
Healthy volunteers: no

Brief summary:
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer

Detailed description:

Arms:
arm 1: TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks. arm 2: TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.

Interventions: intervention 1: TAP-144-SR(6M) intervention 2: TAP-144-SR(3M)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: