Investigating ctDNA in Breast Cancer Treatment
Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.
Gene Solutions · NCT06087120
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 |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Gene Solutions (industry) |
| Drugs / interventions | chemotherapy, Trastuzumab, Pertuzumab, Doxorubicin |
| Locations | 3 sites (Jakarta and 2 other locations) |
| Trial ID | NCT06087120 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with recurrent breast cancer or other metastatic cancers will not benefit from this study.
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 performed: Other studies have shown promise in using ctDNA as a biomarker for treatment response, suggesting that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Jakarta and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Female, Stage II Breast Cancer, Stage III Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Liquid Biopsy, Circulating Tumour DNA, Vietnam