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

June 4, 2023 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homologous recombination repair pathway gene mutation spectrum
Time Frame: At recruitment
to reveal the homologous recombination repair pathway gene mutation spectrum
At recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At 5 years from surgery
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)
At 5 years from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 5, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 4, 2023

First Posted (Estimated)

June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 4, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC-HRR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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