Triple Negative Breast CancerNCT07332975
ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
An observational study of Triple Negative Breast Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 20 Jan 2029
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
Who may be able to join
- Patients must be ≥18 years of age
- Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:
- Clinical stage I
- ≤2 cm on imaging
- cN0
- cM0
Show all 14Show fewer
- Grade 2 or Grade 3
- ECOG 0-2
- Locally assessed ER+ in 0% of cells.
- Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
- No prior chemotherapy
- Fit for chemotherapy and surgery
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Must be willing to provide serial blood samples for the study.
Who cannot join
- History of other invasive malignancy in the past 2 years
- Synchronous breast cancers and multifocal/multicentric breast cancers
- Medical condition or social situation that may preclude adherence to the protocol.
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
UPMC Hillman Cancer
Pittsburgh, Pennsylvania, 15232
Kelsey Mitch, BSN, 4126412357, adamikka2@upmc.edu
Lucia M Borrasso, BSN, 412-641-3304, borrlm@upmc.edu
About this study
Official title: A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
Read the detailed description
A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.
- Conditions
- Triple Negative Breast Cancer
- Keywords
- ctDNA
- Medical subject headings
- Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA detection
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. This assay has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
Measured: Up to 2 years
Secondary outcomes (5)
ctDNA clearing
Percentage of patients clearing the ctDNA during neoadjuvant treatment.
Measured: Up to 2 years
pCR rate
pCR rate (ypT0/is) - All mutations per patient tested in one multiplex PCR reaction containing primers for all 96 mutations. This approach allows the detection of as few as one mutant molecule shed from tumor cells into the circulation per hour, and this detection is sufficient to engender high confidence that the patient has residual disease.
Measured: Up to 2 years
ctDNA after surgery treatment
Percentage of patients with ctDNA after surgery and all treatment.
Measured: Up to 2 years
Event free survival (EFS)
Length of time after primary treatment that the patient remains free of related complications or events.
Measured: Up to 2 years
Invasive disease-free survival (IDFS)
Time until the first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Jan 2026
- Primary completion20 Jan 2029 (estimated)
- Study completion20 Jan 2029 (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 University of PittsburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija Balic, MD PhD, University of Pittsburgh
- Investigators
- Marija Balic, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332975
- Sponsor's protocol ID
- HCC 25-105
- Status last verified
- Mar 2026
- First submitted
- 30 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
- ClinicalTrials.gov ID
- NCT07332975
- Acronym / sponsor ID
- HCC 25-105
- Conditions
- Triple Negative Breast Cancer
- Keywords
- ctDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jan 2029 (estimated)
- Study completion
- 20 Jan 2029 (estimated)
- First posted
- 12 Jan 2026 (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.
This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
Detailed description
A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
Key inclusion criteria (14 listed)
- Patients must be ≥18 years of age
- Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:
- ECOG 0-2
- Locally assessed ER+ in 0% of cells.
- Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
Key exclusion criteria (3 listed)
- History of other invasive malignancy in the past 2 years
- Synchronous breast cancers and multifocal/multicentric breast cancers
- Medical condition or social situation that may preclude adherence to the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ctDNA detection
Time frame: Up to 2 years
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. This assay has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
5 secondary outcomes
ctDNA clearing
Time frame: Up to 2 years
pCR rate
Time frame: Up to 2 years
ctDNA after surgery treatment
Time frame: Up to 2 years
Event free survival (EFS)
Time frame: Up to 2 years
Invasive disease-free survival (IDFS)
Time frame: Up to 2 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 1 May 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.
Marija Balic, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by University of Pittsburgh 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 14 inclusion and 3 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 1 May 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.
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 Kelsey Mitch, BSN (4126412357, adamikka2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA detection (time frame: Up to 2 years). 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 1 May 2026.