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
Overview
- Phase
- Not Applicable
- Intervention
- Abemaciclib and Letrozole/Anastrozole
- Conditions
- Breast Cancer
- Sponsor
- The Affiliated Hospital of Qingdao University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Progression-free survival(PFS)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
BCOOS-A1
The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.
Intervention: Abemaciclib and Letrozole/Anastrozole
BCOOS-A2
The patients in this array are treated with Letrozole or Anastrozole.
Intervention: Letrozole or Anastrozole
BCOOS-B1
The patients in this array are treated with Abemaciclib and Fulvestrant.
Intervention: Abemaciclib and Fulvestrant
BCOOS-B2
The patients in this array are treated with Fulvestrant only.
Intervention: Fulvestrant
Outcomes
Primary Outcomes
Progression-free survival(PFS)
Time Frame: 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 Outcomes
- Objective Remission Rate(ORR)(Up to 36 months)
- Disease Control Rate(DCR)(Up to 36 months)
- Toxicity rate(Up to 36 months)
- Cost-utility analysis(CUA)(Up to 36 months)