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

NCT04768426 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-57723NCI-2021-01757
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.

Conditions

Triple Negative Breast Cancer; Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Baseline levels of ctDNA detection

  In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are: * ctDNA+ (ctDNA-positive) at baseline and at 6 months. * ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months. * ctDNA- at baseline and at 6 months. * ctDNA- at baseline but ctDNA+ at 6 months. The outcome is a number without dispersion.

  6 months

Secondary Outcomes (3)

• Correlation of ctDNA levels with genomic features of tumor

  24 weeks

• Overall Survival (OS)

  5 years

• Relapse-Free Survival

  5 years

Study Arms (1)

Capecitabine

EXPERIMENTAL

1000 mg/m2 administered on Days 1 to 14 of 21-day cycles

Drug: Capecitabine

Interventions

Capecitabine DRUG

1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.

Also known as: fluoropyrimidine carbamate

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms; Neoplasm, Residual

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Melinda Telli

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishal Joshi

CONTACT

650-725-7489; vishalj4@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 24, 2021
• Study Start: February 3, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)