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

NCT05466786 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Observational

Started

2022-08-07

Last updated

2025-10-03

Condition(s) studied

Breast CancerHER2-low Breast Cancer

Investigational drug(s) / intervention(s)

Standard Management

Standard Management: Standard Management

Study 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

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population — At the time of 4 weeks after surgery
the distribution and features of HRD /HRR is evaluated.

Trial sites (1)

Facility	City	Region	Status
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05466786 on ClinicalTrials.gov ↗ ← All trials in China