Evaluating circulating tumor cells in breast cancer after treatment and surgery
The Value of Circulating Tumor Cells in Patients With Breast Cancer Who Completed Surgery After Neoadjuvant Treatment: a Multicenter, Prospective Clinical Trial
This study is testing if collecting and analyzing certain cancer cells from the blood of women with breast cancer after treatment and surgery can help predict their future health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05360290 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical trial aims to assess the prognostic significance of circulating tumor cells (CTCs) in female breast cancer patients who have undergone neoadjuvant treatment followed by surgery. Utilizing the GILUPI CellCollector®, the study will collect and analyze CTCs to determine their potential role in predicting patient outcomes. Participants must have completed their treatment within four years prior to enrollment and meet specific eligibility criteria related to their cancer stage and overall health.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 to 70 with histologically confirmed invasive breast cancer who have completed neoadjuvant treatment and surgery.
Not a fit: Patients with metastatic breast cancer or those who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the prognostic value of CTCs, potentially leading to improved monitoring and treatment strategies for breast cancer patients.
How similar studies have performed: While the use of CTCs in cancer prognosis is a growing field, this specific approach using the GILUPI CellCollector® is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, aged ≥18 and ≤70 years; * Histologically confirmed invasive breast cancer (cT2-4N0-2M0 or cT1N1-3M0 before neoadjuvant treatment); * Completed neoadjuvant treamtment and surgery (within 4 years after surgery); * Administered neoadjuvant chemotherapy (regardless of chemotherapy regimen); * ECOG 0-1 Exclusion Criteria: * Metastatic disease (Stage IV); * Female patients who are pregnancy or lactation; * Uncontrollable puncture site infection or systemic infection;
Where this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wenji Yin
- Email: followroad@163.com
- Phone: 86(21)68385569
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.