Investigating ctDNA in Breast Cancer Treatment
Official title: Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.
Run by Gene Solutions · NCT06087120 · Data updated 2026-11-12
This study is testing if blood samples can help predict how well neoadjuvant chemotherapy works for women with stage II-III HER2-positive and triple-negative breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 125 (estimated) |
| Sponsor | Gene Solutions Industry-sponsored |
| Drugs / interventions | chemotherapy, Trastuzumab, Pertuzumab, Doxorubicin |
| Locations | 3 sites (Jakarta and 2 other locations) |
| Status | Recruiting |
| Started | September 16, 2023 |
| Main results expected | December 1, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 23, 2025 |
| Trial ID | NCT06087120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are females aged 18 and older diagnosed with stage II-III HER2-positive or triple-negative breast cancer who are indicated for neoadjuvant chemotherapy.
✕Probably not a fit
Patients with recurrent breast cancer or other metastatic cancers will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the prognostic and predictive value of circulating tumor DNA (ctDNA) in female patients with stage II-III HER2-positive and triple-negative breast cancer undergoing neoadjuvant chemotherapy. Participants will provide blood samples before, during, and after treatment to assess ctDNA positivity rates and changes over time. The study will also explore the correlation between ctDNA levels and MRI imaging results in predicting pathological complete response (pCR) to therapy. Data will be collected from participants at the Medical Genetics Institute and University Medical Center HCMC in Vietnam.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment responses in breast cancer patients, leading to more personalized and effective treatment strategies.
How similar studies have gone: Other studies have shown promise in using ctDNA as a biomarker for treatment response, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
MRCCC Siloam Hospitals Semanggi
Jakarta, Indonesia Recruiting -
Medical Genetics Institute
Ho Chi Minh City, Vietnam Recruiting -
University Medical Center HCMC
Ho Chi Minh City, Vietnam Recruiting
Study contacts
- Principal investigator: Sinh D Nguyen, PHD — Mgi
- Study coordinator: Lan NL Tu, PHD
- Email: lantu@genesolutions.vn
- Phone: +84888843489
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.