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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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. You should be able to carry out daily activities with 0 level of ability (ECOG 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

Standard Management

Standard Management

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China