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Trial Title:
Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients
NCT ID:
NCT05901025
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Homologous Recombination Repair Pathway
Outcome
Mutation
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
The goal of this clinical trial is to learn about the mutation spectrum of homologous
recombination repair pathway genes and its instructive significance in the treatment of
Chinese breast cancer patients.
Detailed description:
The main questions it aims to answer are:
1. What is the mutation spectrum of homologous recombination repair pathway genes in
Chinese breast cancer patients?
2. Does homologous recombination repair pathway gene mutation have an impact on patient
outcome (breast cancer recurrence, neoadjuvant chemotherapy efficacy, treatment
decisions, etc.) ? There is no intervention on participants, but all participants
will be given regular follow-up post surgery according to ASCO guidelines.
Criteria for eligibility:
Study pop:
Breast cancer patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Pathology-confirmed breast cancer patients who meet at least one of the criteria
below:
- Triple-negative breast cancer
- Age ≤ 50 years
- Male breast cancer
- With personal or family history of malignancy: breast cancer, ovarian cancer,
prostate cancer, pancreatic cancer, other malignancies
- HER-2 negative recurrent or metastatic breast cancer
- HER-2 negative high-risk breast cancer:
A: Neoadjuvant phase: non-pathological complete response for triple-negative breast
cancer; non-pathological complete response AND CPS+EG score ≥ 3 for hormone receptor
positive breast cancer B: Adjuvant phase: ≥ pT2 or ≥ pN1 for triple-negative breast
cancer; ≥ 4 lymph node metastasis for hormone receptor positive breast cancer
2. Having been or intended to be tested for germline and (or) somatic homologous
recombination repair gene mutations
3. Consent to providing medical charts and homologous recombination repair gene testing
results, and being cooperative for long-term follow-up
Exclusion Criteria:
1. Homologous recombination repair gene testing results unavailable
2. Other factors deemed by the investigators that may sabotage the study
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 5, 2023
Completion date:
June 30, 2033
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901025
