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NCT07310420
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer
Conditions: Advanced Breast Cancer
Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 88
Sponsor: TerSera Therapeutics LLC
Location: Genesis Cancer and Blood Institute Hot Springs Arkansas
Summary
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).
Eligibility Criteria
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 \5×ULN with liver metastases.
2. Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome).
12. Renal function: Creatinine clearance (CrCl) ≤30 mL/min as calculated by the Cockcroft-Gault formula.
13. Hematologic parameters:
1. Hemoglobin (Hgb) \
Source: ClinicalTrials.gov (NCT07310420). StuddyBuddy aggregates publicly available trial information.
