Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer

A Multi-center Study of the Clinical Outcomes of Abemaciclib, Palbociclib or Dalpiciclib Combined with Endocrine Therapy As First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer in Real World Practice

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06344780

Enrollment

200

Registered

2024-04-03

Start date

2023-05-20

Completion date

2025-02-01

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Abemaciclib, Palbociclib, Dalpiciclib, HR Positive, HER2 Negative

Brief summary

A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. age \>= 18 years old; 2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023; 3. Received CDK4/6 inhibitors(Abemaciclib, Palbociclib or Dalpiciclib) as first-line therapy for at least one cycle; 4. Complete medical history was available.

Exclusion criteria

1\. Medical history was incomplete.

Design outcomes

Primary

Measure	Time frame	Description
PFS	6 weeks	Pregression-free survival

Secondary

Measure	Time frame	Description
OS	6 weeks	Overall survival

Countries

China

Outcome results