RecruitingNCT05466786

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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

255 participants

Start Date

Aug 7, 2022

Study Type

OBSERVATIONAL

Conditions

Breast Cancer HER2-low Breast Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how common DNA repair gene mutations and a related marker called HRD (homologous recombination deficiency) are in women with HER2-low breast cancer — a recently recognized subtype that may respond to certain targeted therapies. This is a genetic profiling study, not a treatment trial. **You may be eligible if...** - You are female and 18–70 years old - You have confirmed HER2-low breast cancer (IHC 1+ or IHC 2+/ISH negative) - Your cancer has not yet been treated (treatment-naive) - You do not have distant metastases - Your performance status is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have already received treatment for this cancer - Your cancer has spread to other organs - Adequate tumor tissue is not available for testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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