Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether blood tests for tumor DNA can help show who benefits from capecitabine, a cancer drug. It is for adults with early triple-negative breast cancer that remained after chemotherapy given before surgery. Researchers will track tumor DNA during treatment and compare it with the tumors’ genes.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older, with stage I–III triple-negative breast cancer at diagnosis. Estrogen and progesterone receptor levels must each be below 10%.
- Cancer remained after at least 4 rounds of chemotherapy before surgery. Prior experimental immune or targeted treatments are allowed.
- No cancer spread to distant parts of the body. Must be able to care for yourself and be out of bed for at least half the day.
- At least 4 weeks since your last chemotherapy. Most major side effects must be mild or gone; hair loss and moderate nerve damage are allowed.
- Blood counts and liver and kidney test results must meet the study’s limits.
- Plan to receive capecitabine after surgery for 6 months or 8 treatment cycles.
- If able to become pregnant, must have a negative pregnancy test and use effective birth control during treatment and for 3 months after the last dose. Men and their partners who can become pregnant must also use birth control during this time.
- Must be able to sign a consent form and follow the study rules.
Who can't join
- Breast cancer has spread to distant parts of the body.
- Have not had surgery to remove the cancer.
- Pregnant or breastfeeding.
- Have not finished radiation after surgery, if it was planned.
- Known HIV infection or active hepatitis B or C, which are liver infections.
- Used an experimental drug within 4 weeks before starting the study.
- Cannot swallow medicines.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Anatomic stage I - III triple-negative breast cancer at diagnosis 2. Estrogen receptors (ER) and Progesterone receptors (PR) status \<10% 3. 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. 4. ≥ 18 years of age 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 6. 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. 7. No evidence of metastatic disease. 8. A minimum 4-week wash out from previous chemotherapy treatment is required. 9. Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3) 10. 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 11. Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \> 50 mL/min using the Cockcroft Gault formula. 12. Planned for 6 months or 8 cycles of adjuvant capecitabine. 13. Women of childbearing potential (WOCBP) must have a negative pregnancy test. 14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose. 15. 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. 16. 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: 1. Metastatic breast cancer 2. Has not had definitive surgical resection 3. Pregnant or breastfeeding 4. Has not completed definitive adjuvant radiation if planned 5. Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C. 6. Investigational agents within 4 weeks of study initiation 7. Inability to swallow oral medications
Study sites (1)
CA
- Stanford University · Stanford, CA 94304Vishal Joshi · Study contact · 650-725-7489 · vishalj4@stanford.eduMelinda Telli, MD · Principal investigatorMore trials in Stanford