Liquid biopsy could predict who benefits from Post-Chemo breast cancer pill
NCT ID NCT04768426
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests a simple blood test (liquid biopsy) to see if it can tell which triple-negative breast cancer patients will benefit from the drug capecitabine after standard chemotherapy. About 40 adults with leftover cancer after chemo will give blood samples before and during treatment. The goal is to learn if tracking tumor DNA in the blood can help personalize future treatments and reduce the risk of cancer coming back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGStanford, California, 94304, United States
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