CtDNA Based MRD Testing for NAC Monitoring in TNBC

Launched by PERSONALIS INC. · Jan 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor treatment in women with triple-negative breast cancer (TNBC) who are receiving chemotherapy before surgery, known as neoadjuvant chemotherapy (NAC). The researchers want to see if they can detect small amounts of tumor DNA in the blood (called circulating tumor DNA or ctDNA) to help understand how well the treatment is working. The goal is to improve the detection of minimal residual disease (MRD) after treatment and ultimately enhance outcomes for patients in the future.

To participate in this study, women must be at least 18 years old, have confirmed early-stage TNBC, and be scheduled to receive chemotherapy with the aim of curing their cancer. Participants will need to provide blood samples before and during their treatment and share tissue samples from their cancer. The study is currently recruiting, and it is important for interested patients to discuss this opportunity with their healthcare team to see if they qualify and to understand what being part of the trial involves.

Gender

FEMALE

Eligibility criteria

• 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