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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344780
• Other study ID #: YOUNGBC-28
• Status: Recruiting
• Start date: May 20, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: Biyun Wang, Professor
• Phone: +8613701748410
• Email: pro_wangbiyun[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Pregression-free survival	6 weeks
Secondary	OS	Overall survival	6 weeks