Triple Negative Breast CancerPhase 2NCT04768426
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
A Phase 2 study testing Capecitabine in people with Triple Negative Breast Cancer and Breast Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Breast Cancer
- What is being tested?
- Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94304
Vishal Joshi, 650-725-7489, vishalj4@stanford.edu
Melinda Telli, MD
About this study
Official title: Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy
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.
Read the 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 (NAC) receiving standard-of-care adjuvant capecitabine.
The Secondary Objectives are to correlate ctDNA levels with genomic features and survival.
- Conditions
- Triple Negative Breast Cancer, Breast Cancer
- Being tested
- Capecitabine
- Keywords
- TNBC, Triple Negative Breast Cancer, Post neoadjuvant, Residual disease, Capecitabine
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called fluoropyrimidine carbamate
1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | 1000 mg/m2 administered on Days 1 to 14 of 21-day cycles Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Correlation of ctDNA levels with genomic features of tumor
Genomic status of certain mutations in the tumor will be assessed by next-generation sequencing in 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 genes of interest are:
PIK3CA AKT AKT1 PTEN BRCA1 BRCA2 PALB2 CHEK2 ATM NBN BRIP1 BARD1 MRE11 ATR RAD50 RAD51C RAD51D FANCA FANCC FANCD2 FANCE FANCF FANCG FANCL.
The outcome will be reported as the number of participants with a positive mutation status in the gene of interest. The outcome is a number without dispersion.
Measured: 24 weeks
Overall Survival (OS)
Overall survival (OS) will be assessed as participants remaining alive 5 years from the first treatment initiation. The outcome is reported as the number of participants alive (without dispersion).
Measured: 5 years
Relapse-Free Survival
Relapse-free survival is defined as the time from treatment initiation to first invasive relapse or death, through 5 years. The outcome is reported as the number of participants with relapse-free survival (without dispersion) at 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start3 Feb 2021
- Primary completionNov 2026 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda Telli, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768426
- Sponsor's protocol ID
- IRB-57723
- Other IDs
- NCI-2021-01757
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04768426
- Acronym / sponsor ID
- IRB-57723
- Conditions
- Triple Negative Breast Cancer, Breast Cancer
- Keywords
- TNBC, Triple Negative Breast Cancer, Post neoadjuvant, Residual disease, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (NAC) receiving standard-of-care adjuvant capecitabine.
The Secondary Objectives are to correlate ctDNA levels with genomic features and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: Capecitabine1000 mg/m2 administered on Days 1 to 14 of 21-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: fluoropyrimidine carbamate1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles. | Drug | Capecitabine |
Primary outcome
Baseline levels of ctDNA detection
Time frame: 6 months
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.
3 secondary outcomes
Correlation of ctDNA levels with genomic features of tumor
Time frame: 24 weeks
Overall Survival (OS)
Time frame: 5 years
Relapse-Free Survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melinda Telli principal investigator
Stanford Universiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine in people with Triple Negative Breast Cancer and Breast Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vishal Joshi (650-725-7489, vishalj4@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline levels of ctDNA detection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.