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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04768426
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 3, 2021
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Capecitabine
    1000 mg/m2 administered on Days 1 to 14 of 21-day cycles

Primary Outcome Measure

Baseline levels of ctDNA detection [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94304
Vishal Joshi
[email protected]
650-725-7489
Melinda Telli, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Stanford University· Stanford, CA

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