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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06344793
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-20
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Primary Completion: 2024-10-01
• Study Completion: 2025-02-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 608

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	6 weeks	progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	6 weeks	overall survival

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China