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RecruitingObservational

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

NCT ID: NCT06230185Sponsor: Personalis Inc.Last updated: 2025-01-07

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.

Detailed description

NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status.

Outcome measures

Primary

  • Evaluate the correlation of MRD to pCR after NAC in TNBC

    Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.

    Time frame: through study completion, an average of 6 months

Secondary

  • Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC

    Time frame: through study completion, an average of 6 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (14)

Arizona Oncology

Tucson, Arizona, 85704

Recruiting
Rachel Swart, MD · Contact

University of Colorado Cancer Center

Aurora, Colorado, 80045

Recruiting
Peter Kabos, MD · Contact

George Washington University

Washington D.C., District of Columbia, 20037

Recruiting
Richard Lush · Contact
Pavani Chalasani, MD · Contact

Mount Sinai Medical Center of Florida

Miami Beach, Florida, 33140

Recruiting
Yvonne Enriquez-Nunez, · Contact
Oleg Gligich, MD · Contact

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

St. Petersburg, Florida, 33709

Recruiting
Elizabeth Crenshaw · Contact
Neeharika Makani, MD · Contact

Illinois Cancer Care

Peoria, Illinois, 61615

Recruiting
Nadia Rehman, MD · Contact

Louisiana State University

New Orleans, Louisiana, 70112

Recruiting
Alexander Yates · Contact
Michelle Loch, MD · Contact

Trinity Health-Michigan

Ypsilanti, Michigan, 48197

Recruiting
Tareq Al Baghdadi, MD · Contact

Nebraska Methodist

Omaha, Nebraska, 68114

Recruiting
Kathryn Bartz · Contact
Kristen Leu, MD · Contact

Stony Brook University Cancer Center

Stony Brook, New York, 11794

Recruiting
Alison Stopeck, MD · Contact

Oregon Oncology Specialists

Salem, Oregon, 97301

Recruiting
Jocelyn D Nostdahl · Contact
Janelle Meyer, MD · Contact

Cancer Care Associates of York

York, Pennsylvania, 17403

Recruiting
Clarissa Vega · Contact
Joyce Huang, MD · Contact

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Jill Schwartz Gomez · Contact
Carlos Hernando Barcenas, MD · Contact

Cancer Care Northwest

Spokane, Washington, 99202

Recruiting
Ronaye Wagner · Contact
Kristen Rinn, MD · Contact