Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
Recruiting · NCT05466786 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University - Guangzhou, Guangdong, China