Actively Recruiting

Age: 18Years - 70Years
FEMALE
NCT05466786

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

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-10-03

255

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 70 years with pathologically confirmed HER2-low breast cancer (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
  • Absence of distant metastasis
  • Availability of adequate tumor tissue and blood samples for biomarker analysis
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

G

Gong Chang, doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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