Skip to main content
OpenTrials
Completed

NCT Number: NCT06344793

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >= 18 years old;
  • 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;
  • Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
  • Complete medical history was available.

Exclusion criteria

  • Medical history was incomplete.

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    progression-free survival

Secondary outcomes

  1. OS

    Time frame: 6 weeks

    overall survival

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.