Clinical Trial

Open-label, Safety Extension Study for Subjects with Hormone-Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer (OVELIA) Study (TOL2506A-EXT)

MOA: Aromatase inhibitor, First-generation selective estrogen receptor modulator (SERM)

Key Eligibility Criteria:

• Diagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines)
• Is a candidate for endocrine therapy + ovarian suppression LH > 4 IU/L within 28 days prior to Day 1
• Is premenopausal
• No prior (within 28 days prior to Day 1) and/or concomitant use of medications known to prolong the QT/QTc interval
• No prior use of tamoxifen, other SERMs (eg, raloxifene) or antagonists (eg, fulvestrant), aromatase inhibitor, mammalian target of rapamycin (mTOR) inhibitors, or hormone replacement therapy within 3 months before breast cancer diagnosis
• No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer