The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.
GnRH treatment-exposed <6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within <6 months of signing the informed consent.
Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment.
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.
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.
Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.
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
Percentage of Participants with LH Values below a Specified Threshold at Weeks 12, 18, and 24
Percentage of Participants with Estradiol (E2) Suppression at Weeks 6, 12, 18, and 24
Percentage of Participants with Absence of Menses at Weeks 6, 12, 18, and 24
Click on the lead sponsor to view all of their trials.
