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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Gong Chang, doctor
changgong282@163.com
02034070499
Time Frame
Start Date: 2022-08-07
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 255
Treatments
Experimental ARM
All patients received standard care for postoperative management.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov

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