A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer

Qingdao University

Status: Not yet enrolling

Conditions: Breast Cancer; Breast Diseases; Neoplasms

Treatments: Drug: Abemaciclib and Letrozole/Anastrozole; Drug: Fulvestrant; Drug: Abemaciclib and Fulvestrant; Drug: Letrozole or Anastrozole

Study type: Observational

Funder types: Other

Identifiers

NCT06341283

BCOOS2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

BCOOS-A1

Description:

The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.

Treatment:

Drug: Abemaciclib and Letrozole/Anastrozole

BCOOS-A2

Description:

The patients in this array are treated with Letrozole or Anastrozole.

Treatment:

Drug: Letrozole or Anastrozole

BCOOS-B1

Description:

The patients in this array are treated with Abemaciclib and Fulvestrant.

Treatment:

Drug: Abemaciclib and Fulvestrant

BCOOS-B2

Description:

The patients in this array are treated with Fulvestrant only.

Treatment:

Drug: Fulvestrant