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

Sun Yat-sen University

Status: Not yet 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 was a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 335 subjects will be enrolled in this study to examine the distribution and features of HRD (Homologous recombination deficiency)/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: 335 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. female patients who have pathologically documented breast cancer that: Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay ASCO/CAP guidelines in the metastatic setting
2. Femalepatients must be at least 18 years of age
3. ECOG Performance Status of 0 or 1
4. patients with operable primary breast cancer who underwent radical surgery and No patients received preoperative neoadjuvant therapy.
5. No distant metastasis occurred
6. Patient must have adequate tumor andbloodsample for biomarker assessment

Exclusion criteria

1. recurrent or advanced metastatic breast cancer
2. Bilateral breast cancer (including multifocal breast cancer. All histological lesions were HER2 1+ or 2+, not detected by FISH amplification and HR positive according to ASCO guidelines)
3. Other malignant tumors within 5?years
4. Clinical diagnosis and treatment information is incomplete

Trial design

335 participants in 1 patient group

Experimental ARM

Description:

All patients received standard care for postoperative management.

Treatment:

Other: Standard Management