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NCT06344793Completed

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

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
608 (actual)
First submitted
28 Mar 2024
Start date
20 May 2023
Primary completion date
1 Oct 2024
Lead sponsor
Fudan University
NCT number
NCT06344793

What you commit to

  • Study type: Observational
  • Participants enrolled: 608
  • From 20 May 2023 to the primary completion date, 1 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 1\. Medical history was incomplete.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Female

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.