Monitoring circulating tumor DNA in early breast cancer patients
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT04353557 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with histologically confirmed early-stage breast cancer who are undergoing treatment.
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.
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 performed: Other studies have shown promise in using ctDNA monitoring for cancer treatment, indicating that this approach is gaining traction in the field.
Eligibility criteria
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 this trial is running
Chongqing, Chongqing Municipality
- 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
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.