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

STATUS

Recruiting
End date

Feb 21, 2026
participants needed

25
sponsor

Stanford University

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Updated on 21 March 2022

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estrogen

progesterone

capecitabine

mammogram

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.

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 (NAC) receiving standard-of-care adjuvant capecitabine.

The Secondary Objectives are to correlate ctDNA levels with genomic features and survival.

Details

Condition	Triple Negative Breast Cancer, Breast Cancer
Treatment	Capecitabine
Clinical Study Identifier	NCT04768426
Sponsor	Stanford University
Last Modified on	21 March 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	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

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