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NCT06344780 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design

Related Conditions & MeSH terms

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
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