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Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

Recruitingn/aAges 18 Years - anyFemaleGene Solutions
NCT06087120 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 det

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female,18 years old and older, * Are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant chemotherapy, * FFPE sample is available at the time of diagnosis and operation, * Are voluntary to participate in the study. Exclusion Criteria: * Recurrent breast cancer, * Other cancer metastasis to the breast, * Have been or are being treated for cancer, * Patients did not agree to participate in the studies.
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What it tests

  • Not listed
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Where

3 sites
MRCCC Siloam Hospitals Semanggi
Jakarta, Indonesia
Medical Genetics Institute
Ho Chi Minh City, Vietnam
University Medical Center HCMC
Ho Chi Minh City, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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