Clinical trial · Observational
Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor-positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI or TAM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- leuprorelin 3M plus AIs
- description
- leuprorelin 3M: 11.25 mg subcutaneous administration every 3 months for 1 year AIs: anastrozole 1mg /letrozole 2.5mg/exemestane 25mg daily for 1 year
- interventionNames
- Drug: AI or TAM
- label
- leuprorelin 3M plus TAM
- description
- leuprorelin 3M: 11.25 mg subcutaneous administration every 3 months for 1 year TAM: daily for 1 year
- interventionNames
- Drug: AI or TAM
Primary outcomes (1)
- measure
- the suppression proportion of serum estradiol (E2)
- timeFrame
- March,2023
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age≥18 years; 2. Tumor that expressed ER or progesterone receptor in at least 10% of the cells, as assessed by immunohistochemical testing 3. T1 to T3, any N, and M0, according to the TNM classification 4. Any type of breast surgical procedure 5. Any type of preoperative and/or postoperative adjuvant chemotherapy prior to enrollment 6. Capable of receiving the study drug within 12 weeks after surgery or after postoperative chemotherapy completion prior to enrollment 7. Eastern Cooperative Oncology Group performance status of Grade 0 or 1 Exclusion Criteria: 1. Bilateral oophorectomy or ovarian irradiation 2. No use of other OFS drugs
References
Publications (0)
Data not yet available