Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
255 participants
Aug 7, 2022
OBSERVATIONAL
Conditions
Summary
This is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this study to examine the distribution and features of HRD/HRR (homologous recombination repair). In this study, investigators plan to clarify the frequency of HRR/HRD in Chinese patients with HER2-low breast cancer. In addition, it is planned to investigate any association between invasive disease-free survival (iDFS)/overall survival (OS) and HRD/HRR in HER2-low breast cancer patients.
Eligibility
Inclusion Criteria4
- Female patients aged 18-70 years with pathologically confirmed HER2-low breast cancer (defined as IHC 2+/ISH- or IHC 1+ per ASCO/CAP guidelines);
- ECOG performance status of 0 or 1;
- Treatment-naïve operable primary breast cancer with completed homologous recombination deficiency (HRD) assessment;
- ）Absence of distant metastasis; 6）Availability of adequate tumor tissue and blood samples for biomarker analysis.
Exclusion Criteria4
- Recurrent or inoperable locally advanced breast cancer;
- Bilateral breast cancer;
- History of other malignant tumors within the past 5 years;
- Incomplete clinical or pathological data.
Interventions
Standard Management
Locations(1)
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NCT05466786