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PIK3CA Mutation Concordance between Primary and Metastatic Lesions in HR+/HER2- Breast Cancer Patients

PIK3CA Mutation Concordance between Primary and Metastatic Lesions in HR+/HER2- Breast Cancer Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092487
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-21
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Breast Cancer

Interventions

Group of patients with Breast Cancer:none

Sponsors

Jilin Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Women; 2) Breast cancer patients aged >=18 years; 3) Metastatic breast cancer was diagnosed, and metastatic lesions included but were not limited to chest wall recurrence and metastasis, lymph node metastasis, lung metastasis, etc. 4) Patients with archived primary and metastatic tumor specimens, formalin-fixed and paraffin-embedded (FFPE) specimens, and sufficient tumor sections for PIK3CA genetic testing; The requirements for specific tumor specimens are: a) For patients with newly diagnosed nonmetastatic disease, the primary tumor specimen could be the archived tumor specimen obtained at preoperative biopsy, surgery, or diagnosis of metastatic disease, and an archived tumor specimen with any metastatic lesion was required; b) For patients with an initial diagnosis of metastatic disease, an archived tumor specimen of the primary tumor and any metastatic tumor at diagnosis was required; 5) The molecular subtype of the primary tumor was HR+/HER2-.

Exclusion criteria

Exclusion criteria: 1) Previous treatment history of other malignant tumors 2) Bilateral breast cancer

Design outcomes

Primary

MeasureTime frame
Concordance rate of PIK3CA mutation in primary versus matched metastases;

Secondary

MeasureTime frame
Effect of different treatment regimens on concordance of PIK3CA mutation between primary and metastatic lesions;Consistency of detection results between different metastases and primary lesions;To determine whether there is a difference in hotspot mutation frequency between different metastases;

Countries

China

Contacts

Public ContactGuiying Xu

Jilin Cancer Hospital

2831807050@qq.com+86 133 5311 0310

Outcome results

None listed

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