Status:
RECRUITING
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
Lead Sponsor:
Stanford University
Conditions:
Triple Negative Breast Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 no...
Detailed Description
The Primary Objective is to characterize the circulating tumor DNA (ctDNA) profile of triple-negative breast cancer (TNBC) in participants with residual disease after standard neoadjuvant chemotherapy...
Eligibility Criteria
Inclusion
- Anatomic stage I - III triple-negative breast cancer at diagnosis
- Estrogen receptors (ER) and Progesterone receptors (PR) status \<10%
- 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.
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- 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.
- No evidence of metastatic disease.
- A minimum 4-week wash out from previous chemotherapy treatment is required.
- Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
- 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
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \> 50 mL/min using the Cockcroft Gault formula.
- Planned for 6 months or 8 cycles of adjuvant capecitabine.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test.
- WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
- 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.
- 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
- Metastatic breast cancer
- Has not had definitive surgical resection
- Pregnant or breastfeeding
- Has not completed definitive adjuvant radiation if planned
- Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
- Investigational agents within 4 weeks of study initiation
- Inability to swallow oral medications
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04768426
Start Date
February 3 2021
End Date
February 1 2026
Last Update
March 20 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304