The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.
Female aged ≥18 years;
HR+/HER2- invasive breast cancer confirmed by histology (specific definition: ER >10% positive tumor cells by immunohistochemistry is defined as ER positive, PR >10% positive tumor cells is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 + but negative by FISH without amplification was defined as HER2 negative);
Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy;
Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
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Treatment groupsSee each treatment group below.
Fudan University
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
First Hospital of China Medical University
Collaborator
Sun Yat-sen University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Chongqing University Cancer Hospital
Collaborator
Northern Jiangsu People's Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
Shanghai 6th People's Hospital
Collaborator
Affiliated Hospital of Nantong University
Collaborator
Nanchang People's Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
The First Hospital of Jilin University
Collaborator