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

August 31, 2026 updated by: Tempus AI

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35223
    • California
      • Whittier, California, United States, 90602
        • Recruiting
        • PIH Health Whittier Hospital
        • Principal Investigator:
          • Lisa Wang
        • Contact:
    • Florida
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
        • Principal Investigator:
          • Thomas Samuel, MD
    • Illinois
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Southern Illinois Hospital Services
        • Contact:
        • Principal Investigator:
          • Mohammad Popalzi
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Specialist of Illinois
        • Principal Investigator:
          • James Wade
        • Contact:
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Recruiting
        • Goshen Center for Cancer Care
        • Contact:
        • Principal Investigator:
          • James Wheeler
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Oncology Hematology Associates
        • Contact:
        • Principal Investigator:
          • Roger Holden
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Cancer Care Specialist of Reno
        • Contact:
        • Principal Investigator:
          • Sowjanya Reganti
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Principal Investigator:
          • Kerri McGovern, MD
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57401
    • Tennessee
      • Nashville, Tennessee, United States, 37208
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Spokane Valley, Washington, United States, 99216
        • Recruiting
        • Cancer Care Northwest
        • Contact:
        • Principal Investigator:
          • Nikolas Rademaker
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: Neoadjuvant Therapy
There are no interventions in this observational study. Cohort 1 includes participants who will receive neoadjuvant treatment prior to surgery.
Other: There are no interventions in this observational study.
There are no interventions in this observational study.
Cohort 2: Adjuvant Therapy / Surveillance
There are no interventions in this observational study. Cohort 2 includes participants who will receive adjuvant therapy after surgery.
Other: There are no interventions in this observational study.
There are no interventions in this observational study.
Cohort 3: 5 Years Post-Diagnosis Surveillance
There are no interventions in this observational study. Cohort 3 includes participants who have no evidence of disease for at least 5 years post diagnosis.
Other: There are no interventions in this observational study.
There are no interventions in this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Distant disease free survival rates stratified by MRD status during neoadjuvant treatment
Time Frame: 5 years
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
5 years
Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark
Time Frame: 5 years
5 years
Time from First Positive MRD Sample to Recurrence
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tempus AI

Investigators

  • Principal Investigator: Michelle Ting-Lin, MD, Tempus AI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2025

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

September 29, 2025

First Posted (Actual)

October 7, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe