The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
Age and gender: Female participants aged 18 to 55 years, inclusive.
Hormone receptor positive (HR+): Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry.
Participants must be of premenopausal status.
Prior radiotherapy is allowed.
Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
Body mass index (BMI): <18 kg/m² or >35.0 kg/m².
Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.
Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.
Single group
ZOLADEX
DrugParticipants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.
Percentage of Participants with LH Values Below a Specified Threshold at Week 6 Within Each Cohort
Percentage of Participants with LH Values below a Specified Threshold at Weeks 12, 18, and 24 Within Each Cohort
Percentage of Participants with Estradiol (E2) Suppression at Weeks 6, 12, 18, and 24 Within Each Cohort
Percentage of Participants with Absence of Menses at Weeks 6, 12, 18, and 24 Within Each Cohort
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