NCT06087120Recruiting
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.
Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 125 (estimated)
- First submitted
- 11 Oct 2023
- Start date
- 16 Sept 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Gene Solutions
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06087120
What you commit to
- Study type: Observational
- Planned participants: 125
- From 16 Sept 2023 to the primary completion date, 1 Dec 2025
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Recurrent breast cancer,
- Other cancer metastasis to the breast,
- Have been or are being treated for cancer,
Other
- Patients did not agree to participate in the studies.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MRCCC Siloam Hospitals Semanggi Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| University Medical Center HCMC Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| Medical Genetics Institute Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.