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

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06344780
• Lead Sponsor: Fudan University

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.

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
• Status Verified: 2024-08
• Primary Completion: 2024-10-01
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	6 weeks	Pregression-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