A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer
NCT ID: NCT06341283
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2024-06-01
2025-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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BCOOS-A1
The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.
Abemaciclib and Letrozole/Anastrozole
Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
BCOOS-A2
The patients in this array are treated with Letrozole or Anastrozole.
Letrozole or Anastrozole
Take the treatment with Letrozole or Anastrozole.
BCOOS-B1
The patients in this array are treated with Abemaciclib and Fulvestrant.
Abemaciclib and Fulvestrant
Take the treatment with Abemaciclib and Fulvestrant at the same time.
BCOOS-B2
The patients in this array are treated with Fulvestrant only.
Fulvestrant
Take the treatment with Fulvestrant only.
Interventions
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Abemaciclib and Letrozole/Anastrozole
Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
Letrozole or Anastrozole
Take the treatment with Letrozole or Anastrozole.
Abemaciclib and Fulvestrant
Take the treatment with Abemaciclib and Fulvestrant at the same time.
Fulvestrant
Take the treatment with Fulvestrant only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Principal Investigators
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Yu Cao, docter
Role: STUDY_DIRECTOR
The Affiliated Hospital of Qingdao University
Locations
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Clinical Research Center
Qingdao, Shandong, China
Countries
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Central Contacts
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References
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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.
Other Identifiers
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BCOOS2024
Identifier Type: -
Identifier Source: org_study_id
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