RightFit
RecruitingPhase not listed

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at markers in the blood of people with newly diagnosed stage I triple-negative breast cancer. Blood samples are collected before treatment or surgery and again during treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have invasive breast cancer confirmed by testing cells or tissue, with no past treatment for it.
  • Have stage I cancer measuring 2 cm or less on scans, with no signs of spread to nearby lymph nodes or distant body parts.
  • Have grade 2 or 3 cancer, meaning the cancer cells look moderately or very different from normal cells.
  • Testing must show no cells with estrogen receptors and HER2-negative cancer.
  • Be able to care for yourself and be out of bed or a chair for at least half of waking hours.
  • Have had no chemotherapy before and be well enough for chemotherapy and surgery.
  • Be able and willing to sign a consent form and give blood samples several times.

Who can't join

  • Have had another invasive cancer in the past 2 years.
  • Have separate breast cancers at the same time, or cancer in more than one spot in a breast.
  • Have a health condition or life situation that could keep you from following the study plan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Patients must be ≥18 years of age 2. 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 3. ECOG 0-2 4. Locally assessed ER+ in 0% of cells. 5. Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested). 6. No prior chemotherapy 7. Fit for chemotherapy and surgery 8. Must have the ability to understand and the willingness to sign a written informed consent document. 9. Must be willing to provide serial blood samples for the study. Exclusion Criteria: 1. History of other invasive malignancy in the past 2 years 2. Synchronous breast cancers and multifocal/multicentric breast cancers 3. Medical condition or social situation that may preclude adherence to the protocol.

Study sites (1)

PA