Recruiting

Observational Study

Sponsor:

Personalis Inc.

Code:

NCT06230185

Conditions

TNBC - Triple-Negative Breast Cancer

Minimal Residual Disease

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

Conditions

TNBC - Triple-Negative Breast Cancer

Minimal Residual Disease

Study ID

NCT06230185

Start date

Nov 9, 2023

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copy number of <6).
2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
3. Be informed of the investigational nature of the study and all pertinent aspects of the trial.
4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
5. Be ≥ 18years of age.
6. Patient who are scheduled to start NAC.
7. Be willing to provide blood samples before and during treatment.
8. Have available biopsy tissue.

Exclusion Criteria:

1. Receiving concurrent anti-neoplastic therapy for another malignancy.
2. Stage IV disease.
3. Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy.
4. History of allogeneic bone marrow or organ transplant.
5. Blood transfusion within two weeks before collection of blood for central ctDNA testing.
6. Started systemic therapy for their breast cancer.
7. Pregnancy

Study Design

Enrollment

422 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Evaluate the correlation of MRD to pCR after NAC in TNBC [ Time Frame: through study completion, an average of 6 months ]

Central Contacts and Locations

Locations

Arizona Oncology

Recruiting

Tucson, Arizona, United States, 85704

Contacts

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

George Washington University

Recruiting

Washington DC, District of Columbia, United States, 20037

Contacts

Mount Sinai Medical Center of Florida

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC

Recruiting

St. Petersburg, Florida, United States, 33709

Contacts

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Louisiana State University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Trinity Health-Michigan

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Nebraska Methodist

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Stony Brook University Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

Contacts

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Contacts

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Cancer Care Northwest

Recruiting

Spokane, Washington, United States, 99202

Contacts

More Information

Sponsor

Personalis Inc.

Last update posted

Jan 7, 2025

Last verified

Jan, 2025

Keywords

  • ctDNA
  • Liquid Biopsy
  • Breast Cancer
  • MRD
  • NAC
  • TNBC
  • NeXT Personal®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Personalis Inc. on 2025-01-07.