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

NCT05466786 | Recruiting

• 1 other identifier: SYSKY-2022-030-01
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; HER2-low Breast Cancer

Keywords

Homologous recombination-related; Homologous recombination deficiency

Outcome Measures

Primary Outcomes (1)

• 1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population

  the distribution and features of HRD /HRR is evaluated.

  At the time of 4 weeks after surgery

Secondary Outcomes (3)

• To assess the clinical characteristics between patients with mutations and non-mutation

  At the time of 4 weeks after surgery

• To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression

  At the time of 36 months after surgery

• To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression

  At the time of 4 weeks after surgery

Study Arms (1)

Experimental ARM

All patients received standard care for postoperative management.

Other: Standard Management

Interventions

Standard Management OTHER

Standard Management

Experimental ARM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

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;
• ）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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Sample Name：blood Note：Return any surplus after use 2. Sample Name：Tumor tissue Note：Return any surplus after use

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gong Chang, doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gong Chang, doctor

CONTACT

02034070499; changgong282@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 20, 2022
• Study Start: August 7, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)