Actively Recruiting
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
Led by Stanford University · Updated on 2026-04-13
40
Participants Needed
1
Research Sites
542 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosed with stage I to III triple-negative breast cancer
- Estrogen and progesterone receptor status less than 10%
- Residual disease after at least 4 cycles of neoadjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- All significant side effects from prior cancer treatments resolved to Grade 1 or less except hair loss and grade 2 neuropathy
- No evidence of metastatic disease
- At least 4 weeks since last chemotherapy treatment
- Adequate blood cell counts: neutrophils at least 1,500 cells/mcL and platelets at least 100,000 cells/mcL
- Adequate liver function: bilirubin no more than 1.5 times the upper limit of normal (or up to 5 times if Gilbert's syndrome), AST and ALT no more than 2.5 times the upper limit of normal
- Adequate kidney function: serum creatinine no more than 1.5 times upper limit of normal or creatinine clearance over 50 mL/min
- Planned to receive 6 months or 8 cycles of adjuvant capecitabine
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 3 months after
- Male participants and their female partners of childbearing potential must agree to use contraception during the study and for 3 months after
- Able to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Metastatic breast cancer
- No definitive surgical removal of breast cancer
- Pregnant or breastfeeding
- Have not completed planned adjuvant radiation therapy
- Known HIV infection or active hepatitis B or C
- Use of investigational agents within 4 weeks before starting the study
- Unable to swallow oral medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94304
Actively Recruiting
Research Team
V
Vishal Joshi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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