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

Recruiting now

Conditions studied: Breast Cancer, HER2-low Breast Cancer

In brief

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.

Key facts

Study ID: NCT05466786
Run by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
People needed: 255
Starts: 2022-08-07
Expected to finish: 2027-05-31
Last updated by the study team: 2025-10-03

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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);
ECOG performance status of 0 or 1;
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.

You may not qualify if…

Recurrent or inoperable locally advanced breast cancer;
Bilateral breast cancer;
History of other malignant tumors within the past 5 years;
Incomplete clinical or pathological data.

Where it is running

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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