RecruitingNCT06230185
CtDNA Based MRD Testing for NAC Monitoring in TNBC
Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
Sponsor
Personalis Inc.
Enrollment
422 participants
Start Date
Nov 9, 2023
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria8
- 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 Criteria7
- 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.
- Pregnancy
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06230185
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