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

NCT07211178 | Recruiting

• 1 other identifier: TP-CA-010
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 12

Brief 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. 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; HER2 + Breast Cancer; TNBC - Triple-Negative Breast Cancer; HR Positive/HER-2 Negative 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; HER2+ breast cancer

Outcome Measures

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

  5 years

Secondary Outcomes (4)

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

  5 years

• Overall Survival rates stratified by MRD status during neoadjuvant treatment, post-surgery landmark, post definitive treatment (surveillance), and long-term follow-up

  5 years

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

  5 years

• Time from First Positive MRD Sample to Recurrence

  5 years

Study Arms (3)

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.

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.

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.

Interventions

There are no interventions in this observational study. OTHER

There are no interventions in this observational study.

Cohort 1: Neoadjuvant Therapy; Cohort 2: Adjuvant Therapy / Surveillance; Cohort 3: 5 Years Post-Diagnosis Surveillance

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)
• 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
• \. 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+

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tempus AI: lead

Study Sites (12)

Birmingham Hematology Associates

Birmingham, Alabama, 35223, United States

RECRUITING

PIH Health Whittier Hospital

Whittier, California, 90602, United States

RECRUITING

Southern Illinois Hospital Services

Carbondale, Illinois, 62902, United States

RECRUITING

Cancer Care Specialist of Illinois

O'Fallon, Illinois, 62269, United States

RECRUITING

Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

RECRUITING

Trinity Health

Ann Arbor, Michigan, 48106, United States

RECRUITING

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

RECRUITING

Cancer Care Specialist of Reno

Reno, Nevada, 89511, United States

RECRUITING

Summit Medical Group

Florham Park, New Jersey, 07932, United States

RECRUITING

Nashville General

Nashville, Tennessee, 37208, United States

RECRUITING

Cancer Care Northwest

Spokane Valley, Washington, 99216, United States

RECRUITING

Gunderson Health

La Crosse, Wisconsin, 54601, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood and leftover tissue will be collected in the study.

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Ting-Lin, MD

  Tempus AI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GEMINI Breast Clinical Study Manager

CONTACT

(833) 514-4187; gemini-breast@tempus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 7, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2033
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (12)