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.
Study Type
OBSERVATIONAL
Enrollment
255
Standard Management
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITING1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
the distribution and features of HRD /HRR is evaluated.
Time frame: At the time of 4 weeks after surgery
To assess the clinical characteristics between patients with mutations and non-mutation
Association between mutations and non-mutations group in HRD/HRR is assessed.
Time frame: At the time of 4 weeks after surgery
To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression
IDFS, was a composite endpoint defined as the time from enrollment until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. 3-year Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive. Association between IDFS/OS and HRD/HRR information is evaluated.
Time frame: At the time of 36 months after surgery
To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression
Association between multivariate prognostic factors and survival is evaluated.
Time frame: At the time of 4 weeks after surgery
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