Monitoring tumor DNA in blood during capecitabine treatment for 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

This study is testing if a blood test that looks for tumor DNA can help find out if people with early triple-negative breast cancer will benefit from capecitabine treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04768426 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stage I-III triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy.

Not a fit: Patients with metastatic disease or those who do not have triple-negative breast cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help tailor treatment plans for TNBC patients, improving outcomes and reducing unnecessary exposure to ineffective therapies.

How similar studies have performed: Other studies utilizing ctDNA monitoring in cancer treatment have shown promising results, indicating that this approach is gaining traction in the field.

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

Where this trial is running

Stanford, California

• Stanford University — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Melinda Telli — Stanford Universiy
• Study coordinator: Vishal Joshi

Conditions Triple Negative Breast Cancer; Breast Cancer; TNBC; Post neoadjuvant; Residual disease; Capecitabine