Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT07211178

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

Led by Tempus AI · Updated on 2026-03-04

900

Participants Needed

12

Research Sites

422 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to participate in the research and provide biospecimens
  • Willing and able to provide informed consent
  • Must be diagnosed with breast cancer
  • For Cohort 1A: Known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III) at high risk of recurrence
  • For Cohort 1B: Known or suspected HER2+ breast cancer treated with curative intent (Stage II to III), including HR+ or HR-
  • For Cohort 1C: Known or suspected triple negative breast cancer treated with curative intent (Stage I to III)
  • For Cohort 2A: Known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III) at high risk of recurrence, post-surgery with no clinical evidence of disease
  • For Cohort 2B: Known or suspected HER2+ breast cancer treated with curative intent (Stage II to III), post-surgery with no clinical evidence of disease
  • For Cohort 2C: Known or suspected triple negative breast cancer treated with curative intent (Stage I to III), post-surgery with no clinical evidence of disease
  • For Cohort 3: Known HR+, HER2- breast cancer treated with curative intent (Stage II to III), no evidence of disease for 5 or more years after diagnosis and at high risk of recurrence
Not Eligible

You will not qualify if you...

  • Not willing or able to follow the study procedures
  • Having an active secondary cancer
  • Diagnosed with another cancer within 3 years of the breast cancer diagnosis (except ductal carcinoma in situ within 3 years)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Birmingham Hematology Associates

Birmingham, Alabama, United States, 35223

Actively Recruiting

2

PIH Health Whittier Hospital

Whittier, California, United States, 90602

Actively Recruiting

3

Southern Illinois Hospital Services

Carbondale, Illinois, United States, 62902

Actively Recruiting

4

Cancer Care Specialist of Illinois

O'Fallon, Illinois, United States, 62269

Actively Recruiting

5

Goshen Center for Cancer Care

Goshen, Indiana, United States, 46526

Actively Recruiting

6

Trinity Health

Ann Arbor, Michigan, United States, 48106

Actively Recruiting

7

Oncology Hematology Associates

Springfield, Missouri, United States, 65807

Actively Recruiting

8

Cancer Care Specialist of Reno

Reno, Nevada, United States, 89511

Actively Recruiting

9

Summit Medical Group

Florham Park, New Jersey, United States, 07932

Actively Recruiting

10

Nashville General

Nashville, Tennessee, United States, 37208

Actively Recruiting

11

Cancer Care Northwest

Spokane Valley, Washington, United States, 99216

Actively Recruiting

12

Gunderson Health

La Crosse, Wisconsin, United States, 54601

Actively Recruiting

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Research Team

G

GEMINI Breast Clinical Study Manager

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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