Triple Negative Breast Cancer
Conditions
Keywords
ctDNA
Brief summary
This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
Detailed description
A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.
Interventions
None listed
Sponsors
University of Pittsburgh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be ≥18 years of age 2. Cytologically or histologically confirmed and previously untreated invasive breast cancer that is: * Clinical stage I * ≤2 cm on imaging * cN0 * cM0 * Grade 2 or Grade 3 3. ECOG 0-2 4. Locally assessed ER+ in 0% of cells. 5. Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested). 6. No prior chemotherapy 7. Fit for chemotherapy and surgery 8. Must have the ability to understand and the willingness to sign a written informed consent document. 9. Must be willing to provide serial blood samples for the study.
Exclusion criteria
1. History of other invasive malignancy in the past 2 years 2. Synchronous breast cancers and multifocal/multicentric breast cancers 3. Medical condition or social situation that may preclude adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA detection | Up to 2 years | Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. This assay has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA clearing | Up to 2 years | Percentage of patients clearing the ctDNA during neoadjuvant treatment. |
| pCR rate | Up to 2 years | pCR rate (ypT0/is) - All mutations per patient tested in one multiplex PCR reaction containing primers for all 96 mutations. This approach allows the detection of as few as one mutant molecule shed from tumor cells into the circulation per hour, and this detection is sufficient to engender high confidence that the patient has residual disease. |
| ctDNA after surgery treatment | Up to 2 years | Percentage of patients with ctDNA after surgery and all treatment. |
| Event free survival (EFS) | Up to 2 years | Length of time after primary treatment that the patient remains free of related complications or events. |
| Invasive disease-free survival (IDFS) | Up to 2 years | Time until the first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause. |
Countries
United States
Contacts
CONTACTKelsey Mitch, BSN
CONTACTLucia M Borrasso, BSN
PRINCIPAL_INVESTIGATORMarija Balic, MD
UPMC Hillman Cancer Center
Outcome results
None listed