Breast Cancer, HER2-low Breast Cancer
Conditions
Keywords
Homologous recombination-related, Homologous recombination deficiency
Brief 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.
Interventions
OTHERStandard Management
Standard Management
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population | At the time of 4 weeks after surgery | the distribution and features of HRD /HRR is evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the clinical characteristics between patients with mutations and non-mutation | At the time of 4 weeks after surgery | Association between mutations and non-mutations group in HRD/HRR is assessed. |
| To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression | At the time of 36 months after surgery | IDFS, was a composite endpoint defined as the time from enrollment until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. 3-year Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive. Association between IDFS/OS and HRD/HRR information is evaluated. |
| To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression | At the time of 4 weeks after surgery | Association between multivariate prognostic factors and survival is evaluated. |
Countries
China
Contacts
Primary ContactGong Chang, doctor
Outcome results
None listed