NCT06341283

A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

A Retrospective Real-world Study of Efficacy, Safety, and Economic Assessment of Abemaciclib Tablets Based on Hospital Information System(HIS) in Hormone Recepter Positive(HR+) Breast Cancer Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer.

Detailed description

Based on clinical trials data, Abemaciclib has been approved for early and advanced breast cancer with HR+ and human epidermal growth factor 2 receptor-negative(HER2-), but clinical trials require real-world research data as supplementary validation supporting evidence. This study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with HR+ breast cancer. In addition, this trial will explore the efficacy of Abemaciclib in patients with HR+ and human epidermal growth factor 2 receptor-positive(Her2+) breast cancer. This study will now include real-world data on efficacy, toxicity and economics of abemaciclib in the adjuvant setting in HR+ breast cancer. Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled. The investigators are going to gather 2 groups of breast-cancer-one-other-study(BCOOS) including BCOOS-A and BCOOS-B. Group BCOOS-A includes the patients treated with Abemaciclib and Letrozole/Anastrozole compared with treated with Letrozole/Anastrozole only. Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only. Investigators will measure clinical outcomes, adverse events and economics in each group above.

Conditions

• Breast Cancer
• Neoplasms
• Breast Diseases

Interventions

Type	Name	Description
DRUG	Abemaciclib and Letrozole/Anastrozole	Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
DRUG	Letrozole or Anastrozole	Take the treatment with Letrozole or Anastrozole.
DRUG	Abemaciclib and Fulvestrant	Take the treatment with Abemaciclib and Fulvestrant at the same time.
DRUG	Fulvestrant	Take the treatment with Fulvestrant only.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-31
• Completion: 2025-07-01
• First posted: 2024-04-02
• Last updated: 2024-05-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study