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NCT Number: NCT07332975

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

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.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. ctDNA clearing

    Time frame: Up to 2 years

    Percentage of patients clearing the ctDNA during neoadjuvant treatment.

  2. pCR rate

    Time frame: Up to 2 years

    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.

  3. ctDNA after surgery treatment

    Time frame: Up to 2 years

    Percentage of patients with ctDNA after surgery and all treatment.

  4. Event free survival (EFS)

    Time frame: Up to 2 years

    Length of time after primary treatment that the patient remains free of related complications or events.

  5. Invasive disease-free survival (IDFS)

    Time frame: Up to 2 years

    Time until the first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Mitch, BSN

CONTACT

[email protected]

4126412357

Lucia M Borrasso, BSN

CONTACT

[email protected]

4126413304

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 12, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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