NCT06230185 · Personalis Inc.
CtDNA Based MRD Testing for NAC Monitoring in TNBC
(B-STRONGER-I)
What this study is about
A forward-looking, conducted at multiple hospitals, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological full disappearance of disease signs (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
- Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
- Be informed of the investigational nature of the study and all pertinent aspects of the trial.
- Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
- Be ≥ 18years of age.
- Patient who are scheduled to start NAC.
- Be willing to provide blood samples before and during treatment.
- Have available biopsy tissue.
Exclusion criteria
- Receiving concurrent anti-neoplastic therapy for another malignancy.
- Stage IV disease.
- 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.
- History of allogeneic bone marrow or organ transplant.
- Blood transfusion within two weeks before collection of blood for central ctDNA testing.
- Started systemic therapy for their breast cancer.
Where
- Tucson, Arizona
- Aurora, Colorado
- Washington D.C., District of Columbia
- Miami Beach, Florida
- St. Petersburg, Florida
- Peoria, Illinois
- New Orleans, Louisiana
- Ypsilanti, Michigan
- Omaha, Nebraska
- Stony Brook, New York
- Salem, Oregon
- York, Pennsylvania
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2025 · Source of record for eligibility and locations