HRR gene changes and homologous recombination deficiency in HER2-low breast cancer
Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT05466786
This study will test how common HRR gene mutations and homologous recombination deficiency are in Chinese women with HER2-low breast cancer and whether those markers relate to survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 255 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05466786 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional, observational study enrolling about 255 patients with HER2-low breast cancer who have completed HRD testing. Investigators will analyze tumor and blood samples to describe the frequency and molecular features of HRR gene alterations and HRD. Clinical data will be linked to outcomes to explore associations with invasive disease-free survival and overall survival. The study is investigator-initiated and conducted at a single center in Guangzhou, China.
Who should consider this trial
Good fit: Women aged 18–70 with pathologically confirmed HER2-low operable primary breast cancer (IHC 1+ or IHC 2+/ISH-), ECOG 0–1, completed HRD assessment, no distant metastasis, and available tumor and blood samples.
Not a fit: Patients with recurrent or inoperable locally advanced disease, bilateral breast cancer, another malignancy within the past five years, or incomplete clinical/pathologic data are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help doctors identify HER2-low patients with HRD who might benefit from targeted therapies and improve prognosis prediction.
How similar studies have performed: Previous studies have linked HRD/HRR alterations to response to PARP inhibitors in breast cancer, but the specific distribution and prognostic value in HER2-low patients are not well defined.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Gong Chang, doctor — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Gong Chang, doctor
- Email: changgong282@163.com
- Phone: 02034070499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, HER2-low Breast Cancer, Homologous recombination-related, Homologous recombination deficiency