Monitoring tumor DNA in blood during capecitabine treatment for early triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a circulating tumor DNA (ctDNA) assay, also known as a 'liquid biopsy', to identify triple-negative breast cancer (TNBC) patients who may benefit from capecitabine treatment. Participants with residual disease after neoadjuvant chemotherapy will be monitored for changes in ctDNA levels during their capecitabine treatment. The study aims to correlate ctDNA analysis results with the genetic characteristics of individual tumors, potentially guiding future treatment decisions to reduce the risk of cancer relapse.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Melinda Telli — Stanford Universiy
• Study coordinator: Vishal Joshi
• Email: vishalj4@stanford.edu
• Phone: 650-725-7489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.