Clinical trial NCT05466786: Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
Official title: Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
HER2-low Breast Cancer
Keywords: Homologous recombination-related
Homologous recombination deficiency
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 335
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients who have pathologically documented breast cancer that: Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay ASCO/CAP guidelines in the metastatic setting

Brief summary: This was a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 335 subjects will be enrolled in this study to examine the distribution and features of HRD (Homologous recombination deficiency)/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 criteria: Inclusion Criteria:

1. female patients who have pathologically documented breast cancer that: Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay ASCO/CAP guidelines in the metastatic setting
2. Femalepatients must be at least 18 years of age
3. ECOG Performance Status of 0 or 1
4. patients with operable primary breast cancer who underwent radical surgery and No patients received preoperative neoadjuvant therapy.
5. No distant metastasis occurred
6. Patient must have adequate tumor andbloodsample for biomarker assessment

Exclusion Criteria:

1. recurrent or advanced metastatic breast cancer
2. Bilateral breast cancer (including multifocal breast cancer. All histological lesions were HER2 1+ or 2+, not detected by FISH amplification and HR positive according to ASCO guidelines)
3. Other malignant tumors within 5?years
4. Clinical diagnosis and treatment information is incomplete

Primary outcomes:
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 18 mouths after surgery
Secondary outcomes:
measure: To assess the clinical characteristics between patients with mutations and non-mutation
timeFrame: At the time of 18 mouths after surgery
measure: To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression
timeFrame: At the time of 36 months after surgery
measure: To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression
timeFrame: At the time of 18 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Gong Chang, doctor
role: PRINCIPAL_INVESTIGATOR
References: