RecruitingNCT06087120

Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.


Sponsor

Gene Solutions

Enrollment

125 participants

Start Date

Sep 16, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment. * Determine the rate of ctDNA positivity at the time before treatment, * Determine the rate of ctDNA positivity at the time during treatment, * Determine the rate of ctDNA positivity at the time after neoadjuvant therapy, whether there is a change in ctDNA expression of the study population during treatment. And aiming to investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy: * Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA, * Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI * Combination of ctDNA detection and MRI imaging in the prognosis of pCR. Determination of PPV, NPV ratio of ctDNA combined with MRI.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a blood test that detects tumor DNA (called ctDNA) can predict how well breast cancer will respond to pre-surgery chemotherapy. By measuring cancer DNA fragments in the blood at different points during treatment, researchers hope to find a way to monitor treatment effectiveness without invasive procedures. **You may be eligible if...** - You are female and 18 or older - You have been diagnosed with stage II or III HER2-positive or triple-negative breast cancer - You are scheduled to receive chemotherapy before surgery (neoadjuvant chemotherapy) - A preserved tissue sample from your biopsy is available **You may NOT be eligible if...** - Your breast cancer has returned after prior treatment - You have a different cancer that has spread to the breast - You have already received cancer treatment for a current diagnosis - You do not wish to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

MRCCC Siloam Hospitals Semanggi

Jakarta, Indonesia

Medical Genetics Institute

Ho Chi Minh City, Vietnam

University Medical Center HCMC

Ho Chi Minh City, Vietnam

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NCT06087120


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