Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-nega… (NCT04768426) | Clinical Trial Compass
RecruitingPhase 2
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
United States40 participantsStarted 2021-02-03
Plain-language summary
The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Anatomic stage I - III triple-negative breast cancer at diagnosis
✓. Estrogen receptors (ER) and Progesterone receptors (PR) status \<10%
✓. Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted therapy during the neoadjuvant phase of treatment are eligible.
✓. ≥ 18 years of age
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
✓. All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
✓. No evidence of metastatic disease.
✓. A minimum 4-week wash out from previous chemotherapy treatment is required.