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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341283
• Other study ID #: BCOOS2024
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: The Affiliated Hospital of Qingdao University
• Contact: Yu Cao, docter
• Phone: +8653282911261
• Email: caoyu[@]qdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms
• Neoplasms

Intervention

Drug:
• Abemaciclib and Letrozole/Anastrozole
Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
• Letrozole or Anastrozole
Take the treatment with Letrozole or Anastrozole.
• Abemaciclib and Fulvestrant
Take the treatment with Abemaciclib and Fulvestrant at the same time.
• Fulvestrant
Take the treatment with Fulvestrant only.

Locations

Country	Name	City	State
China	Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival(PFS)	The time from treatment initiation to either the first documented disease progression or death from any cause.	Through the completion of the study, for an average of 6 months
Secondary	Objective Remission Rate(ORR)	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.	Up to 36 months
Secondary	Disease Control Rate(DCR)	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	Up to 36 months
Secondary	Toxicity rate	Adverse events from the time from treatment initiation to disease progression, patient death or last recorded	Up to 36 months
Secondary	Cost-utility analysis(CUA)	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.	Up to 36 months