NCT04768426 · Stanford University
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
What this study 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.
View original scientific description
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.
Interventions
DRUG
Capecitabine
1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.
Primary outcome measures
Baseline levels of ctDNA detection
Time frame: 6 months
In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are: * ctDNA+ (ctDNA-positive) at baseline and at 6 months. * ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months. * ctDNA- at baseline and at 6 months. * ctDNA- at baseline but ctDNA+ at 6 months. The outcome is a number without dispersion.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
- Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \> 50 mL/min using the Cockcroft Gault formula.
- Planned for 6 months or 8 cycles of adjuvant capecitabine.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
- Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.
- Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Exclusion criteria
- Metastatic breast cancer
- Has not had definitive surgical resection
- Pregnant or breastfeeding
- Has not completed definitive adjuvant radiation if planned
- Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
- Investigational agents within 4 weeks of study initiation
- Inability to swallow oral medications
Where
- Stanford, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations