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

Not yet recruiting

• Conditions: Breast Cancer; Breast Diseases; Neoplasms
• Interventions: Drug: Letrozole or Anastrozole; Drug: Abemaciclib and Fulvestrant; Drug: Fulvestrant; Drug: Abemaciclib and Letrozole/Anastrozole

• Registration Number: NCT06341283
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Study Start: 2024-06-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 18 years or older
• Histologically confirmed HR-positive breast cancer and Imaging/pathological evidence of metastasis is available
• Treatment with abemaciclib in combination with endocrine therapy
• Any endocrine therapy
• Having solid tumor efficacy evaluation criteria RECIST 1.1 measurable lesions

Exclusion Criteria

• Combined with other primary malignancies
• Associated with serious non-tumor related diseases, such as cardiovascular system, respiratory system, nervous system, blood system, digestive system
• Pregnant or lactating women
• male breast cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BCOOS-A2	Letrozole or Anastrozole	The patients in this array are treated with Letrozole or Anastrozole.
BCOOS-B1	Abemaciclib and Fulvestrant	The patients in this array are treated with Abemaciclib and Fulvestrant.
BCOOS-B2	Fulvestrant	The patients in this array are treated with Fulvestrant only.
BCOOS-A1	Abemaciclib and Letrozole/Anastrozole	The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.

Primary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	Through the completion of the study, for an average of 6 months	The time from treatment initiation to either the first documented disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Objective Remission Rate(ORR)	Up to 36 months	The proportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit was the sum of complete response (CR) and partial response (PR) proportions.
Disease Control Rate(DCR)	Up to 36 months	The number of patients who achieved complete response(CR),partial response (PR) and stable lesion (SD) after treatment as a percentage of the evaluable cases
Toxicity rate	Up to 36 months	Adverse events from the time from treatment initiation to disease progression, patient death or last recorded
Cost-utility analysis(CUA)	Up to 36 months	In health economics the purpose of CUA is to estimate the ratio between the cost of a health-related intervention and the benefit it produces in terms of the number of years lived in full health by the beneficiaries.

Trial Locations

Locations (1)

Clinical Research Center; 🇨🇳 Qingdao, Shandong, China