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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorTempus AI

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • There are no interventions in this observational study.

    Other intervention

    There are no interventions in this observational study.

Treatment groups

900 Participants
are divided into 3 treatment groups
Group A: Cohort 1: Neoadjuvant Therapy1 intervention
Group B: Cohort 2: Adjuvant Therapy / Surveillance1 intervention
Group C: Cohort 3: 5 Years Post-Diagnosis Surveillance1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Distant disease free survival rates stratified by MRD status during neoadjuvant treatment

Time frame
5 years
2

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
3

Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark

Time frame
5 years
4

Time from First Positive MRD Sample to Recurrence

Time frame
5 years

Other outcomes

Sponsors and contacts

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