Clinical trial · Observational
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-low Breast Cancer | HER2-Low Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental ARM
- description
- All patients received standard care for postoperative management.
- interventionNames
- Other: Standard Management
Primary outcomes (1)
- measure
- 1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
- timeFrame
- At the time of 4 weeks after surgery
- description
- the distribution and features of HRD /HRR is evaluated.
Secondary outcomes (3)
- measure
- To assess the clinical characteristics between patients with mutations and non-mutation
- timeFrame
- At the time of 4 weeks after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available