Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: There are no interventions in this observational study..
- Who it may be relevant to
- Registry conditions: Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other There are no interventions in this observational study.
There are no interventions in this observational study.
Primary outcome measures
- Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up [Time frame: 5 years]
Secondary outcome measures (4)
- Distant disease free survival rates stratified by MRD status during neoadjuvant treatment [Time frame: 5 years]
- Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up [Time frame: 5 years]
- Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark [Time frame: 5 years]
- Time from First Positive MRD Sample to Recurrence [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
All Cohorts:
- Willing and able to participate in the research and provide biospecimens
- Willing and able to provide informed consent
- Must be diagnosed with breast cancer
Cohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-
- A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
- 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-
- A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
- 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.
- Have undergone curative intent surgery with no clinical evidence of disease.
Cohort 2B: HER2+
- A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)
- Have undergone curative intent surgery with no clinical evidence of disease.
Cohort 2C: Triple Negative Breast Cancer
- A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)
- Have undergone curative intent surgery with no clinical evidence of disease.
Cohort 3: 5-Years Post-Diagnosis Surveillance (NED)
- A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).
- No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.
- 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
- Not willing or able to adhere with the study procedures
- Active secondary malignancy
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 14 centers
- Birmingham Hematology Associates — Birmingham
- PIH Health Whittier Hospital — Whittier
- Cleveland Clinic Florida — Weston
- Southern Illinois Hospital Services — Carbondale
- Cancer Care Specialist of Illinois — O'Fallon
- Goshen Center for Cancer Care — Goshen
- Trinity Health — Ann Arbor
- Oncology Hematology Associates — Springfield
- … and 6 more centers
Identifiers
NCT: NCT07211178 · TP-CA-010