Multicenter clinical research for investigating clinical utility of ESR1 and PIK3CA hotspot mutations detection and serial tracking using ultra-high sensitive method for metastatic hormone receptor positive breast cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0009582
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 200
Age 19 or older at the time of obtaining consent
- Patients diagnosed with hormone receptor positive, HER2 overexpression negative metastatic breast cancer
- Patients using or planning to use CDK 4/6 inhibitor as conventional anti-hormonal treatment
- Patients for whom primary breast cancer specimens were obtained at the time of diagnosis to confirm ESR1 and PIK3CA mutations
- Patients with confirmed clinical pathology information such as age at the time of surgery, grade, tumor size, and presence of lymph node metastasis.
- Patients eligible for imaging tests to evaluate treatment response
- Patients eligible for serial blood sampling during anti-hormonal treatment
- Patients diagnosed histologically with phyllodes tumor or sarcoma
- Patients diagnosed with other cancers before breast cancer
- Male breast cancer patient
- Patients who have difficulty understanding research due to mental illness
- Patients who plan to undergo follow-up at a location other than the research institution
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predicting prognosis and treatment responsiveness by identifying ESR1 and PIK3CA mutations in the blood at the time of tumor and metastasis in patients with metastatic breast cancer.
- Secondary Outcome Measures
Name Time Method Comparison of real-time changes in ESR1 and PIK3CA mutations in serial ctDNA during anti-hormone treatment among metastatic breast cancer patients and clinical disease progression