Clinical trial · Observational
A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer
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
NCT06341283CI-TRIAL-00077029unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Diseases | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib and Fulvestrant | Drug | — | UNRESOLVED |
| Abemaciclib and Letrozole/Anastrozole | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Letrozole or Anastrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- BCOOS-A1
- description
- The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.
- interventionNames
- Drug: Abemaciclib and Letrozole/Anastrozole
- label
- BCOOS-A2
- description
- The patients in this array are treated with Letrozole or Anastrozole.
- interventionNames
- Drug: Letrozole or Anastrozole
- label
- BCOOS-B1
- description
- The patients in this array are treated with Abemaciclib and Fulvestrant.
- interventionNames
- Drug: Abemaciclib and Fulvestrant
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTZhang 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. PMID 33149768