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

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05466786
• Collaborator: (none)
• Enrollment: 335
• Location: 1
• Anticipated Duration (Months): 58.5
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; HER2-low Breast Cancer	Other: Standard Management

Study Design

• Study Type: Observational
• Anticipated Enrollment: 335 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
• Anticipated Study Start Date: Jul 15, 2022
• Anticipated Primary Completion Date: May 31, 2027
• Anticipated Study Completion Date: May 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental ARM All patients received standard care for postoperative management.	Other: Standard Management; Standard Management

Outcome Measures

Primary Outcome Measures

1. 1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population [At the time of 18 mouths after surgery]

   the distribution and features of HRD /HRR is evaluated.

Secondary Outcome Measures

1. To assess the clinical characteristics between patients with mutations and non-mutation [At the time of 18 mouths after surgery]

   Association between mutations and non-mutations group in HRD/HRR is assessed.

2. 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.

3. 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 18 months after surgery]

   Association between multivariate prognostic factors and survival is evaluated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

• Principal Investigator: Gong Chang, doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gong, Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT05466786
• Other Study ID Numbers: SYSKY-2022-030-01
• First Posted: Jul 20, 2022
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chang Gong, Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: Homologous recombination-related; Homologous recombination deficiency
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 20, 2022