Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

Launched by STANFORD UNIVERSITY · Feb 19, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help doctors understand how well a treatment called capecitabine works for patients with early-stage triple-negative breast cancer (TNBC). The study will use a special test that checks for circulating tumor DNA (ctDNA) in the blood, which can give clues about whether the treatment is effective. By monitoring changes in ctDNA over time, researchers hope to identify which patients may benefit most from capecitabine and potentially explore different treatments for those who might not respond well.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with stage I-III triple-negative breast cancer. They should have had some treatment already, but still have residual disease. Women who can become pregnant will need to have a negative pregnancy test and agree to use contraception during the study. Participants will receive capecitabine for about six months and will have their blood tested regularly to monitor ctDNA levels. This study is important because it may help tailor future treatments for breast cancer patients based on their individual needs.

Gender

ALL

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