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Multicenter clinical research for investigating clinical utility of ESR1 and PIK3CA hotspot mutations detection and serial tracking using ultra-high sensitive method for hormone receptor positive breast cancer

Multicenter clinical research for investigating clinical utility of ESR1 and PIK3CA hotspot mutations detection and serial tracking using ultra-high sensitive method for hormone receptor positive breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009582
Enrollment
200
Registered
2024-06-28
Start date
2025-07-31
Completion date
Unknown
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) 19 years of age or older at the time of obtaining consent 2) Patients diagnosed with hormone receptor positive, HER2 overexpression negative breast cancer A. Patients diagnosed with metastatic breast cancer : those who are undergoing or scheduled to undergo palliative hormonal therapy OR B. Patients diagnosed with locally advanced breast cancer: those who have undergone neoadjuvant chemotherapy or adjuvant chemotherapy. 3) Patients for whom primary breast cancer specimens were obtained at the time of diagnosis to confirm ESR1 and PIK3CA mutations 4) Patients with confirmed clinical pathology information such as age at the time of surgery, grade, tumor size, and presence of lymph node metastasis. 5) Patients eligible for imaging tests to evaluate treatment response 6) Patients eligible for serial blood sampling during anti-hormonal treatment

Exclusion criteria

Exclusion criteria: 1) Patients diagnosed histologically with phyllodes tumor or sarcoma 2) Patients diagnosed with other cancers before breast cancer 3) Male breast cancer patient 4) Patients who have difficulty understanding research due to mental illness 5) Patients who plan to undergo follow-up at a location other than the research institution

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSae Byul Lee

Asan Medical Center

newstar153@hanmail.net+82-2-3010-1729

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026