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NCT05901025Not yet recruiting

Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients

Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients: A Multi-center, Prospective, Observational Study

Source: ClinicalTrials.gov · Last updated 13 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
4 Jun 2023
Start date
5 Jun 2023
Primary completion date
30 Jun 2028
Lead sponsor
Shanghai Jiao Tong University School of Medicine
NCT number
NCT05901025

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 5 Jun 2023 to the primary completion date, 30 Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Homologous recombination repair gene testing results unavailable
  • Other factors deemed by the investigators that may sabotage the study

Who the study is looking for

  • 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
  • Having been or intended to be tested for germline and (or) somatic homologous recombination repair gene mutations
  • Consent to providing medical charts and homologous recombination repair gene testing results, and being cooperative for long-term follow-up

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.