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

Sun Yat-sen University

Status: Enrolling

Conditions: Breast Cancer; HER2-low Breast Cancer

Treatments: Other: Standard Management

Study type: Observational

Funder types: Other

Identifiers

NCT05466786

SYSKY-2022-030-01

Details and patient eligibility

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.

Enrollment: 255 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

255 participants in 1 patient group

Experimental ARM

Description:

All patients received standard care for postoperative management.

Treatment:

Other: Standard Management