Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer

A Multi-center Study of the Clinical Outcomes Between Initial CDK 4/6 Inhibitor Plus Endocrine Therapy and Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer in Real World Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06344793

Enrollment

608

Registered

2024-04-03

Start date

2023-05-20

Completion date

2025-02-01

Last updated

2025-07-28

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

Conditions

Breast Cancer

Keywords

chemotherapy, CDK 4/6 Inhibitor, HR Positive, HER2 Negative

Brief summary

A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy 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

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 inhibitor plus endocrine treatment or chemotherapy 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	progression-free survival

Secondary

Measure	Time frame	Description
OS	6 weeks	overall survival

Countries

China

Outcome results