About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to participate in the research and provide biospecimens
Willing and able to provide informed consent
Must be diagnosed with breast cancer
A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)
Disqualifiers
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.
Trial population
The population of this study includes early stage breast cancer patients with triple negative breast cancer (Stages I to III), HER2 positive (Stages II and III), and high risk HR positive HER-2 negative (Stages II and III).
Trial design
Cohort
Prospective
Treatments tested in this trial
There are no interventions in this observational study.
Other interventionThere are no interventions in this observational study.
Treatment groups
Trial outcomes
Primary outcomes
Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
Secondary outcomes
Distant disease free survival rates stratified by MRD status during neoadjuvant treatment
Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark
Time from First Positive MRD Sample to Recurrence