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NCT Number: NCT05466786

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms HER2-low Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Gong Chang, doctor

CONTACT

[email protected]

02034070499

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Standard management

Other

Standard Management

Primary outcomes

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

    Time frame: At the time of 4 weeks after surgery

    the distribution and features of HRD /HRR is evaluated.

Secondary outcomes

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

    Time frame: At the time of 4 weeks after surgery

    Association between mutations and non-mutations group in HRD/HRR is assessed.

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

    Time frame: At the time of 36 months after surgery

    IDFS, was a composite endpoint defined as the time from enrollment until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.

    3-year Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive.

    Association between IDFS/OS and HRD/HRR information is evaluated.

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

    Time frame: At the time of 4 weeks after surgery

    Association between multivariate prognostic factors and survival is evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Gong Chang, doctor

CONTACT

[email protected]

02034070499

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2022
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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