Efficacy and Safety of Leuprorelin Acetate Every-3-months Depot Plus an Aromatase Inhibitor or Tamoxifen in Premenopausal Women With Hormone Receptor-positive Breast Cancer: a Clinical Prospective Observational Study

NCT04891731 UNKNOWN

Leuprorelin, a LHRH agonist, acts as a potent inhibitor of gonadotropin secretion and is commonly used for the treatment of hormone-responsive prostate cancer, premenopausal HR+ breast cancer, endometriosis and uterine fibroids. It is currently available in 1M, 3M, 6M for subcutaneous administration. Initially administration would stimulate an increase in LH and FSH, causing a transient increase of E2 in 2-4 weeks. Continuous administration results in a subsequent decrease in E2 levels, as a result of decreased levels of luteinizing LH and FSH. After stopping injection, ovarian function could gradually recover. Adverse events related to leuprorelin include flushing, mood swings and urogenital symptoms. At present, the treatment of premenopausal breast cancer mainly includes 1M and 3M GnRHa. Leuprorelin 11.25mg dosage form is currently the only 3M GnRHa in China that has gotten breast cancer indications. The use of 3M GnRHa could improve patients' compliance and reduce injection discomfort. However, previous studies about GnRHa alone or in combination with TAM or AIs usually used 1M GnRHa. There have been few studies reporting the suppression effects of E2 levels and clinical outcome with leuprorelin 3M in combination with TAM or AIs.

Details

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status	UNKNOWN
Enrolment	120
Start date	2021-05
Completion	2023-09

Conditions

• Hormone Receptor-positive Breast Cancer

Interventions

• AI or TAM

Primary outcomes

• the suppression proportion of serum estradiol (E2) — March,2023
  The suppression proportion of serum estradiol (E2) to the menopausal level (E2≤30 pg/mL) at different time points (4, 12, 24, 36 and 48 weeks) during the first year for leuprorelin 3M depot plus TAM or AIs.