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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-07

Study Completion Date

2027-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer HER2-low Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental ARM

All patients received standard care for postoperative management.

Standard Management

Intervention Type OTHER

Standard Management

Interventions

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Standard Management

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No