Clinical trial

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

Name

BCOOS2024

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2024-12-31

Trial end

2025-07-01

Status

Not yet recruiting

Treatment

Abemaciclib and Letrozole/Anastrozole

Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.

Arms:

BCOOS-A1

Other names:

BCOOS-A1

Letrozole or Anastrozole

Take the treatment with Letrozole or Anastrozole.

Arms:

BCOOS-A2

Other names:

BCOOS-A2

Abemaciclib and Fulvestrant

Take the treatment with Abemaciclib and Fulvestrant at the same time.

Arms:

BCOOS-B1

Other names:

BCOOS-B1

Fulvestrant

Take the treatment with Fulvestrant only.

Arms:

BCOOS-B2

Other names:

BCOOS-B2

Size

200

Primary endpoint

Progression-free survival(PFS)

Through the completion of the study, for an average of 6 months

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

Updated at

2024-05-10

1 organization

3 products

1 drug

3 indications

Organization

The Affiliated Hospital of Qingdao University

Product

Abemaciclib + Letrozole/Anastrozole

Indication

Breast Cancer