An observational study in Breast Cancer, Neoplasms and Breast Diseases, sponsored by The Affiliated Hospital of Qingdao University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by The Affiliated Hospital of Qingdao University · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 200 is close to the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with histologically confirmed HR-positive breast cancer treated with abemaciclib in combination with endocrine therapy
Exclusion Criteria:
The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.
Drug: Abemaciclib and Letrozole/Anastrozole
The patients in this array are treated with Letrozole or Anastrozole.
Drug: Letrozole or Anastrozole
The patients in this array are treated with Abemaciclib and Fulvestrant.
Drug: Abemaciclib and Fulvestrant
The patients in this array are treated with Fulvestrant only.
Drug: Fulvestrant
Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
Also known as: BCOOS-A1
Take the treatment with Letrozole or Anastrozole.
Also known as: BCOOS-A2
Take the treatment with Abemaciclib and Fulvestrant at the same time.
Also known as: BCOOS-B1
Take the treatment with Fulvestrant only.
Also known as: BCOOS-B2
Progression-free survival(PFS)
The time from treatment initiation to either the first documented disease progression or death from any cause.
Time frame: Through the completion of the study, for an average of 6 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.
Time frame: 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
Time frame: Up to 36 months
Toxicity rate
Adverse events from the time from treatment initiation to disease progression, patient death or last recorded
Time frame: 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.
Time frame: Up to 36 months
Plan to share: Undecided
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Qingdao University