Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Management.
- Who it may be relevant to
- Registry conditions: Breast Cancer, HER2-low Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
Overview
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.
Interventions
- Other Standard Management
Standard Management
Primary outcome measures
- 1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population [Time frame: At the time of 4 weeks after surgery]
Secondary outcome measures (3)
- To assess the clinical characteristics between patients with mutations and non-mutation [Time frame: At the time of 4 weeks after surgery]
- To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression [Time frame: At the time of 36 months after surgery]
- To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression [Time frame: At the time of 4 weeks after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Recurrent or inoperable locally advanced breast cancer;
- Bilateral breast cancer;
- History of other malignant tumors within the past 5 years;
- Incomplete clinical or pathological data.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT05466786 · SYSKY-2022-030-01