Breast CancerGEMINI BreastNCT07211178
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
An observational study of Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Tempus AI at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer
- How many people
- 900 participants
- Where
- 16 sitesUnited States
- Study dates
- 27 Oct 2025to Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Show all 24Show fewer
- 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.
Who cannot join
- 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 locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Trinity Health
Ann Arbor, Michigan, 48106
Christina Munson, christina.munson@trinity-health.org
Tareq Al baghdadi
- Recruiting
Birmingham Hematology Associates
Birmingham, Alabama, 35223
Amanda Joseph, Amanda.Joseph@alabamaoncology.com
Matthew Tucker
- Recruiting
Southern Illinois Hospital Services
Carbondale, Illinois, 62902
Sumita Kolay, Sumita.kolay@sih.net
Mohammad Popalzi
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Andrea Whitley, whitleal@ucmail.uc.edu
Kerri McGovern, MD
- Recruiting
Summit Medical Group
Florham Park, New Jersey, 07932
Michelle Mackenzie, mmackenzie@summithealth.com
Steven Parish
- Recruiting
Goshen Center for Cancer Care
Goshen, Indiana, 46526
Kim Neff, kneff2@goshenhealth.com
James Wheeler
- Recruiting
UT Health Houston
Houston, Texas, 77030
Elnaz Ghalechi, Elnaz.RezaeiGhalechi@uth.tmc.edu
Iman Doostan, MD
- Recruiting
Gunderson Health
La Crosse, Wisconsin, 54601
Charlie Abney, charlie.abney@emplifyhealth.org
Paul Letendre
- Recruiting
Nashville General
Nashville, Tennessee, 37208
Shatika Phillips, shatika.phillips@nashvilleha.org
Robin Jacob
- Recruiting
Cancer Care Specialist of Illinois
O'Fallon, Illinois, 62269
Kaitlynn Knapp, kkapp@ccsci.net
James Wade
- Recruiting
Cancer Care Specialist of Reno
Reno, Nevada, 89511
Layla Quinonez, lquinonez@ccsreno.com
Sowjanya Reganti
- Recruiting
Sanford - Sioux Falls
Sioux Falls, South Dakota, 57401
Jane Veerman, jane.veerman@sanfordhealth.org
Alison Watson, MD
- Recruiting
Cancer Care Northwest
Spokane Valley, Washington, 99216
Rachel Bender, Rachel.Bender@ccnw.net
Nikolas Rademaker
- Recruiting
Oncology Hematology Associates
Springfield, Missouri, 65807
Adrianna Moore, Adrianna.Moore@aoncology.com
Roger Holden
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Maria Dimayuga, dimayum@ccf.org
Thomas Samuel, MD
- Recruiting
PIH Health Whittier Hospital
Whittier, California, 90602
Lucia Nguyen, 562-698-0811, lucia.nguyen@pihhealth.org
Lisa Wang
About this study
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
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer, Early Stage Breast Cancer
- Being tested
- There are no interventions in this observational study.
- Keywords
- Minimal Residual Disease, MRD, Next generation sequencing, NGS, ctDNA, Early Stage Breast Cancer, TNBC - Triple Negative Breast Cancer, HR positive / HER-2 negative breast cancer, HER2+ breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions in this observational study.Other
There are no interventions in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Neoadjuvant Therapy | There are no interventions in this observational study. Cohort 1 includes participants who will receive neoadjuvant treatment prior to surgery. Receives: Other: 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. Receives: Other: 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. Receives: Other: There are no interventions in this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (iDFS) stratified by MRD status during neoadjuvant, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
Measured: 5 years
Secondary outcomes (4)
Distant disease free survival rates stratified by MRD status during neoadjuvant treatment
Measured: 5 years
Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up
Measured: 5 years
Pathologic Complete Response (pCR) or Residual Cancer Burden (RCB) rate stratified by MRD status at post-surgery landmark
Measured: 5 years
Time from First Positive MRD Sample to Recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start27 Oct 2025
- Primary completionDec 2032 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tempus AIThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tempus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Ting-Lin, MD, Principal investigator, Tempus AI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211178
- Sponsor's protocol ID
- TP-CA-010
- Acronym
- GEMINI Breast
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
- ClinicalTrials.gov ID
- NCT07211178
- Acronym / sponsor ID
- GEMINI Breast / TP-CA-010
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer, Early Stage Breast Cancer
- Keywords
- Minimal Residual Disease, MRD, Next generation sequencing, NGS, ctDNA, Early Stage Breast Cancer, TNBC - Triple Negative Breast Cancer, HR positive / HER-2 negative breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Tempus AIIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Neoadjuvant Therapy | – | Other: There are no interventions in this observational study.There are no interventions in this observational study. Cohort 1 includes participants who will receive neoadjuvant treatment prior to surgery. |
| Cohort 2: Adjuvant Therapy / Surveillance | – | Other: There are no interventions in this observational study.There are no interventions in this observational study. Cohort 2 includes participants who will receive adjuvant therapy after surgery. |
| Cohort 3: 5 Years Post-Diagnosis Surveillance | – | Other: There are no interventions in this observational study.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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (24 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There are no interventions in this observational study.There are no interventions in this observational study. | Other | Cohort 1: Neoadjuvant Therapy, Cohort 2: Adjuvant Therapy / Surveillance, Cohort 3: 5 Years Post-Diagnosis Surveillance |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Ting-Lin, MD principal investigator
Tempus AI
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Tempus AI at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GEMINI Breast Clinical Study Manager ((833) 514-4187, gemini-breast@tempus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.