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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neoplasms; Breast Cancer; Breast Diseases
• Intervention / Treatment: Drug: Abemaciclib and Letrozole/Anastrozole; Drug: Letrozole or Anastrozole; Drug: Abemaciclib and Fulvestrant; Drug: Fulvestrant

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yu Cao, docter; Phone Number: +8653282911261; Email: caoyu@qdu.edu.cn

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed HR-positive breast cancer treated with abemaciclib in combination with endocrine therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BCOOS-A1; The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.	Drug: Abemaciclib and Letrozole/Anastrozole; Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.; Other Names: BCOOS-A1
BCOOS-A2; The patients in this array are treated with Letrozole or Anastrozole.	Drug: Letrozole or Anastrozole; Take the treatment with Letrozole or Anastrozole.; Other Names: BCOOS-A2
BCOOS-B1; The patients in this array are treated with Abemaciclib and Fulvestrant.	Drug: Abemaciclib and Fulvestrant; Take the treatment with Abemaciclib and Fulvestrant at the same time.; Other Names: BCOOS-B1
BCOOS-B2; The patients in this array are treated with Fulvestrant only.	Drug: Fulvestrant; Take the treatment with Fulvestrant only.; Other Names: BCOOS-B2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity rate	Adverse events from the time from treatment initiation to disease progression, patient death or last recorded	Up to 36 months
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
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
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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Director: Yu Cao, docter, The Affiliated Hospital of Qingdao University

Publications and helpful links

General Publications

• 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 plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Abemaciclib; Real world study
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Letrozole; Fulvestrant; Anastrozole
• Other Study ID Numbers: BCOOS2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No