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Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies

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 to 99 Years
Sex
All sexes
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: Blood draws, 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
  • "A simple blood test, often called a liquid biopsy, can detect this ctDNA."
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 tests whether blood tests can find tiny bits of breast cancer DNA over time. It looks at whether these tests can help predict if cancer will come back or show if treatment is working. It is for people with certain types and stages of breast cancer during treatment or follow-up care.

For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later. A way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working. Ultimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.

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

Eligibility

Who can join

  • You must have breast cancer and be willing and able to take part, give samples for testing, and give informed consent (agree after learning about the study).
  • You must fit one of the study groups below. Treatment must aim to cure the cancer.
  • Before surgery: You may qualify with newly diagnosed, high-risk stage II–III HR-positive, HER2-negative cancer. HR-positive means hormones help the cancer grow; HER2-negative means it does not have high levels of the HER2 protein.
  • Before surgery: You may qualify with stage II–III HER2-positive cancer (high levels of the HER2 protein), with or without hormone receptors.
  • Before surgery: You may qualify with stage I–III triple-negative cancer (without hormone receptors or high HER2 levels).
  • After surgery: You may qualify with one of the types and stages listed above, with no signs of cancer after surgery meant to cure it. HR-positive, HER2-negative cancer must be newly diagnosed and high risk.
  • Long-term follow-up: You must have known stage II–III, high-risk HR-positive, HER2-negative cancer, with no signs of cancer at least 5 years after diagnosis.
  • High risk means cancer in 4 or more underarm lymph nodes, or in 1–3 nodes plus either a tumor at least 5 cm wide or grade 3 cancer (cells that look very abnormal). Lymph nodes are small parts of the body's defense system.

Who can't join

  • You are not willing or able to follow the study steps.
  • You have another active cancer.
  • You were diagnosed with another cancer within 3 years of your breast cancer diagnosis. DCIS (abnormal cells inside breast milk ducts) in either breast does not exclude you.

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

Official eligibility criteria

Inclusion Criteria: All Cohorts: 1. Willing and able to participate in the research and provide biospecimens 2. Willing and able to provide informed consent 3. Must be diagnosed with breast cancer Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2- 1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease) 2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger. Cohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients. Cohort 1C: Triple Negative Breast Cancer 1\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease). Cohort 2: Adjuvant Therapy / Surveillance Cohort 2A: Newly Diagnosed HR+,HER2- 1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease) 2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger. 3. Have undergone curative intent surgery with no clinical evidence of disease. Cohort 2B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease) 2. Have undergone curative intent surgery with no clinical evidence of disease. Cohort 2C: Triple Negative Breast Cancer 1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease) 2. Have undergone curative intent surgery with no clinical evidence of disease. Cohort 3: 5-Years Post-Diagnosis Surveillance (NED) 1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease). 2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis. 3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger. Exclusion Criteria: 1. Not willing or able to adhere with the study procedures 2. Active secondary malignancy 3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.

Study sites (16)

AL

CA

FL

IL

IN

MI

MO

NJ

NV

OH

SD

TN

TX

WA

WI