Monitoring circulating tumor DNA in early breast cancer patients
Official title: Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
Run by Geneplus-Beijing Co. Ltd. · NCT04353557 · Data updated 2026-11-12
This study is testing if tracking a specific type of DNA in the blood can help doctors understand how well treatments are working for people with early-stage breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | November 29, 2019 |
| Main results expected | June 2025 |
| Study ends | December 2026 |
| Registry record updated | July 18, 2024 |
| Trial ID | NCT04353557 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 80 with histologically confirmed early-stage breast cancer who are undergoing treatment.
✕Probably not a fit
Patients with severe ECOG performance status or those with a history of other cancers in the past five years may 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 focuses on monitoring circulating tumor DNA (ctDNA) in patients diagnosed with early-stage breast cancer. It aims to assess the prognostic value of ctDNA and its role in monitoring treatment outcomes. The study will involve patients who have undergone various treatments, including neoadjuvant therapy and surgery, to evaluate how ctDNA levels correlate with their clinical progress. By analyzing blood samples, researchers hope to gain insights into the effectiveness of treatments and the potential for personalized patient care.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for monitoring treatment response and prognosis in early breast cancer patients.
How similar studies have gone: Other studies have shown promise in using ctDNA monitoring for cancer treatment, indicating that this approach is gaining traction in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 80 years old 2. Histologically proven primary breast cancer with clinical stage I-III 3. Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated). 4. Expected to achieve R0 resection. 5. Estimated lifetime is more than 3 months. 6. Signed Informed Consent Form 7. Consent to provide research blood samples. Exclusion Criteria: 1. Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5. 2. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5. 3. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ. 4. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.
Where it's running
-
Army Medical Center of PLA, China
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Study coordinator: Yan Xu, M.D.
- Email: xy931@163.com
- Phone: (+86)159 2310 0038
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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.