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NCT Number: NCT05901025

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

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.

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Key information

About this study

The main questions it aims to answer are:

  • What is the mutation spectrum of homologous recombination repair pathway genes in Chinese breast cancer patients?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Homologous recombination repair pathway gene mutation spectrum

    Time frame: At recruitment

    to reveal the homologous recombination repair pathway gene mutation spectrum

Secondary outcomes

  1. Breast cancer events

    Time frame: At 5 years from surgery

    to compare the incidence of breast cancer-related events and deaths between patients with or without homologous recombination repair pathway gene mutation(s)

  2. Treatment decision and appliance

    Time frame: At 5 years from surgery

    to compare the treatment decision and appliance between patients with or without homologous recombination repair pathway gene mutation(s)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Jun 13, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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