Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer
TerSera Therapeutics LLC
Summary
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
Description
The purpose of this study is to assess the degree and consistency of ovarian suppression achieved following administration of ZOLADEX 10.8 mg. Ovarian suppression will be evaluated by measuring LH levels over the treatment period.
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Age and gender: 1. Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive. 2. 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. 2. 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. 3. HR+: Either est…
Interventions
- DrugZOLADEX
Participants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.
Locations (3)
- Duly Health and CareLisle, Illinois
- Presence Infusion CareSkokie, Illinois
- Profound Research LLC at Michigan Hematology and Oncology ConsultantsRoyal Oak, Michigan