ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

University of Pittsburgh77 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Triple Negative Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UPMC Hillman Cancer

Pittsburgh, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

ctDNA detection

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.

Time frame: Up to 2 years

Secondary Outcomes

ctDNA clearing

Percentage of patients clearing the ctDNA during neoadjuvant treatment.

Time frame: Up to 2 years

pCR rate

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.

Time frame: Up to 2 years

ctDNA after surgery treatment

Percentage of patients with ctDNA after surgery and all treatment.

Time frame: Up to 2 years

Event free survival (EFS)

Length of time after primary treatment that the patient remains free of related complications or events.

Time frame: Up to 2 years

Invasive disease-free survival (IDFS)

Time until the first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause.

Time frame: Up to 2 years