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Active Not Recruiting NCT05466786

Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer

Conditions: Breast Cancer, HER2-low Breast Cancer

Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Enrollment: 255
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Location: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangzhou Guangdong

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 Criteria

Inclusion Criteria: 1. 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); 2. ECOG performance status of 0 or 1; 3. Treatment-naïve operable primary breast cancer with completed homologous recombination deficiency (HRD) assessment; 5)Absence of distant metastasis; 6)Availability of adequate tumor tissue and blood samples for biomarker analysis. Exclusion Criteria: 1. Recurrent or inoperable locally advanced breast cancer; 2. Bilateral breast cancer; 3. History of other malignant tumors within the past 5 years; 4. Incomplete clinical or pathological data.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05466786). StuddyBuddy aggregates publicly available trial information.