Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466786
• Other study ID #: SYSKY-2022-030-01
• Status: Not yet recruiting
• Start date: July 15, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: July 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Gong Chang, doctor
• Phone: 02034070499
• Email: changgong282[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 335
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Standard Management
Standard Management

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population	the distribution and features of HRD /HRR is evaluated.	At the time of 18 mouths after surgery
Secondary	To assess the clinical characteristics between patients with mutations and non-mutation	Association between mutations and non-mutations group in HRD/HRR is assessed.	At the time of 18 mouths after surgery
Secondary	To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression	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.	At the time of 36 months after surgery
Secondary	To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression	Association between multivariate prognostic factors and survival is evaluated.	At the time of 18 months after surgery