Breast Cancer, Breast Diseases, Neoplasms
Conditions
Keywords
Abemaciclib, Real world study, Breast Cancer
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.
Interventions
DRUGAbemaciclib and Letrozole/Anastrozole
Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
Take the treatment with Letrozole or Anastrozole.
DRUGAbemaciclib and Fulvestrant
Take the treatment with Abemaciclib and Fulvestrant at the same time.
DRUGFulvestrant
Take the treatment with Fulvestrant only.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYu Cao, docter
Outcome results
None listed