Clinical trial NCT06341283: A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Neoplasms
Breast Diseases
Keywords: Abemaciclib
Real world study
Breast Cancer
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed HR-positive breast cancer treated with abemaciclib in combination with endocrine therapy

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.

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

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: Through the completion of the study, for an average of 6 months
Secondary outcomes:
measure: Objective Remission Rate(ORR)
timeFrame: Up to 36 months
measure: Disease Control Rate(DCR)
timeFrame: Up to 36 months
measure: Toxicity rate
timeFrame: Up to 36 months
measure: Cost-utility analysis(CUA)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Clinical Research Center
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yu Cao, docter
role: STUDY_DIRECTOR
References:
citation: 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.