Development and Validation of an Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients, and the Creation of a Digital Gene Library to Support an Evidence-based Diagnostic Algorithm
New Blood Test Strategy for Advanced Breast Cancer
Plain English Summary
Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients, is a Not Applicable clinical trial sponsored by European Institute of Oncology studying Breast Cancer, Metastatic. This study tests a new blood test method to find specific genetic changes (ESR-1 and gBRCA mutations) in advanced breast cancer. It is for patients with HR+/HER2- metastatic breast cancer, including those who have or haven't started treatment for advanced disease, or whose cancer has progressed after certain treatments. Participation involves providing blood samples for testing and potentially contributing to a digital library of genetic information. Current alternatives involve tissue biopsies, which can be more invasive and may not always capture all necessary genetic information. The trial aims to enroll 80 participants.
Official Summary
Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+/HER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with a confirmed diagnosis of HR+/HER2- metastatic breast cancer. Individuals who have not yet started treatment for metastatic disease, or whose cancer has progressed after treatment with CDK4/6 inhibitors. Patients must be able to provide informed consent. Individuals unable to provide informed consent cannot participate. This trial is studying Breast Cancer, Metastatic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The creation of a digital gene library will help build a reliable system for doctors to use genetic information from blood tests to guide treatment choices for patients. The specific primary outcome measures are: the creation of a digital gene library to support an evidence-based diagnostic algorithm (2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve how we detect key genetic mutations in advanced breast cancer using a less invasive blood test, potentially leading to more personalized treatment decisio This research targets Breast Cancer, Metastatic, where improved treatment options are needed.
Investor Insight
This trial addresses a growing need for advanced diagnostic tools in the large and competitive metastatic breast cancer market, with potential for improved patient outcomes and market adoption if succ
Is This Trial Right for Me?
Ask your doctor if this blood test could be right for you and how it might change your treatment plan. Participation involves giving blood samples, and the process is designed to be as convenient as possible. Your genetic information may be added to a secure digital library to help advance research. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 80 participants
Primary Outcomes
- the creation of a digital gene library to support an evidence-based diagnostic algorithm (2 years)
Full Eligibility Criteria
Inclusion Criteria:
* Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PgR+) breast cancer through histological and/or cytological examination by the local laboratory Participants must exhibit HER2-negative breast cancer
1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.
* Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4/6 inhibitors. However, the primary tumor should be treated according to the standard of care.
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Exclusion Criteria:
* Unable to provide written informed consentTrial Locations
- European Institute of oncology, Milan, Italy, Italy
Frequently Asked Questions
What is clinical trial NCT06762483?
NCT06762483 is a Not Applicable OBSERVATIONAL study titled "Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+/HER2- Metastatic Breast Cancer (mBC) Patients,." It is currently recruiting and is sponsored by European Institute of Oncology. The trial targets enrollment of 80 participants.
What conditions does NCT06762483 study?
This trial investigates treatments for Breast Cancer, Metastatic. The primary condition under study is Breast Cancer, Metastatic.
What does Not Applicable mean for NCT06762483?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06762483?
This trial is currently "Recruiting." It started on 2024-12-20. The estimated completion date is 2030-12-31.
Who is sponsoring NCT06762483?
NCT06762483 is sponsored by European Institute of Oncology. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06762483?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT06762483 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06762483?
The primary outcome measures are: the creation of a digital gene library to support an evidence-based diagnostic algorithm (2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06762483 being conducted?
This trial is being conducted at 1 site, including Milan, Italy (Italy).
Where can I find official information about NCT06762483?
The official record for NCT06762483 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06762483. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06762483 testing in simple terms?
This study tests a new blood test method to find specific genetic changes (ESR-1 and gBRCA mutations) in advanced breast cancer. It is for patients with HR+/HER2- metastatic breast cancer, including those who have or haven't started treatment for advanced disease, or whose cancer has progressed after certain treatments.
Why is this trial significant?
This trial matters because it aims to improve how we detect key genetic mutations in advanced breast cancer using a less invasive blood test, potentially leading to more personalized treatment decisio
What are the potential risks of participating in NCT06762483?
The primary risk is that the blood test may not detect all relevant mutations, or may have false positive/negative results. Potential side effects are minimal and related to blood draws, such as bruising or discomfort at the injection site. There is a small risk of incidental findings in the genetic analysis that may have implications for other health conditions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06762483?
Ask your doctor if this blood test could be right for you and how it might change your treatment plan. Participation involves giving blood samples, and the process is designed to be as convenient as possible. Your genetic information may be added to a secure digital library to help advance research. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06762483 signal from an investment perspective?
This trial addresses a growing need for advanced diagnostic tools in the large and competitive metastatic breast cancer market, with potential for improved patient outcomes and market adoption if succ This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood samples for testing and potentially contributing to a digital library of genetic information. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Breast Cancer, Metastatic Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.