Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer

NCT04891731 | Unknown FDA Drug

• 1 other identifier: SunYatsenU2H-LQ5
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hormone Receptor-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• the suppression proportion of serum estradiol (E2)

  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.

  March,2023

Secondary Outcomes (2)

• Quality of Life (QoL)

  March,2023

• Adverse events(AEs)

  March,2023

Study Arms (2)

leuprorelin 3M plus AIs

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

Drug: AI or TAM

leuprorelin 3M plus TAM

leuprorelin 3M: 11.25 mg subcutaneous administration every 3 months for 1 year TAM: daily for 1 year

Drug: AI or TAM

Interventions

AI or TAM DRUG

This is an observational study, the researcher will describe the ratio of E2 control between leuprorelin plus TAM or leuprorelin plus AIs patients based on the actual clinical use.

leuprorelin 3M plus AIs; leuprorelin 3M plus TAM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal patients with histologically confirmed hormone receptor-positive breast cancer

You may qualify if:

• age≥18 years;
• Tumor that expressed ER or progesterone receptor in at least 10% of the cells, as assessed by immunohistochemical testing
• T1 to T3, any N, and M0, according to the TNM classification
• Any type of breast surgical procedure
• Any type of preoperative and/or postoperative adjuvant chemotherapy prior to enrollment
• Capable of receiving the study drug within 12 weeks after surgery or after postoperative chemotherapy completion prior to enrollment
• Eastern Cooperative Oncology Group performance status of Grade 0 or 1

You may not qualify if:

• Bilateral oophorectomy or ovarian irradiation
• No use of other OFS drugs

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Officials

• Qiang Liu, MD

  Sunyat-sen Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingna Lin, MD

CONTACT

18819430558; 229320178@qq.com

Yudong Li, MD

CONTACT

020-34071156; 910870698@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 18, 2021

Record last verified: 2021-05