To Study the Safety and Efficacy of Ormeloxifen and Leuprolide Combination in Giant Juvenile Fibroadenoma as Case Series

A bstract Introduction: Giant juvenile fibroadenomas are benign breast tumours that typically affect adolescent females, often causing significant breast asymmetry and psychological distress. While surgery is the standard treatment, hormonal therapies, including selective oestrogen receptor modulators and gonadotropin-releasing hormone agonists, have emerged as non-invasive alternatives. Aim: To assess the safety and efficacy of the combination of ormeloxifene and leuprolide acetate in treating giant juvenile fibroadenomas as a non-invasive alternative to surgery. Materials and Methods: This prospective observational study evaluated fibroadenoma regression in patients aged 11–19 years with breast lumps >5 cm. After informed consent or assent, patients underwent clinical examination, ultrasonography, biopsy and hormonal studies. Treatment included monthly subcutaneous leuprolide (3.75 mg) at 0, 1 and 2 months, with weekly ormeloxifene (30 mg) and daily calcium supplementation (500 mg) for 3 months. Monthly follow-ups assessed tumour size and side effects. Exclusion criteria included patients over 19 or with specific health conditions. Results: The combination of ormeloxifene and leuprolide acetate resulted in significant reductions in fibroadenoma size, ranging from 16% to 60%, with 42% of patients experiencing a substantial reduction. None required surgical intervention post-treatment. The most common side effect was menstrual irregularity (28.57%), while 71.43% reported no side effects. Fibroadenomas were predominantly located in the upper outer breast quadrant. No severe side effects like nausea or hypersensitivity were noted, indicating good tolerability. Conclusion: The combination of ormeloxifene and leuprolide acetate is an effective, well-tolerated non-invasive treatment for giant juvenile fibroadenomas, offering a promising alternative to surgery. The treatment resulted in significant tumour size reduction with minimal side effects, but further studies are needed to confirm its long-term safety and efficacy as a first-line therapy.