Monitoring circulating tumor DNA in breast cancer patients receiving neoadjuvant therapy
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
This study is testing if measuring circulating tumor DNA can help doctors see how well neoadjuvant therapy is working for people with stage I-III breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05649475 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of circulating tumor DNA (ctDNA) as a biomarker for assessing the response to neoadjuvant therapy in patients with stage I-III breast cancer. Participants will be monitored for ctDNA levels before, during, and after treatment to determine if changes correlate with treatment response. The study will include patients who are 18 years or older and have not received prior anti-cancer treatments. The goal is to provide insights into the utility of ctDNA in guiding treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage I-III invasive breast cancer who are considered suitable for neoadjuvant therapy.
Not a fit: Patients with other aggressive malignancies, inflammatory breast cancer, or serious concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for breast cancer patients, improving outcomes and minimizing unnecessary therapies.
How similar studies have performed: Other studies have shown promise in using ctDNA as a biomarker in various cancers, suggesting potential success for this approach in breast cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is ≥ 18 years-old at the time of consent to participate this trial * Patients with stage I-III invasive breast cancer * No prior anti-cancer treatment * Felt to be a possible candidate for neoadjuvant therapy by their physician Exclusion Criteria: * Known to have other aggressive malignant tumor in the past 5 years. * Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators. * There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Where this trial is running
Hangzhou
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Yunxiang Zhou
- Email: yxzhou@zju.edu.cn
- Phone: +8615868131018
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.