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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA clearing | Percentage of patients clearing the ctDNA during neoadjuvant treatment. | 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. |
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Inclusion Criteria:
Patients must be ≥18 years of age
Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:
ECOG 0-2
Locally assessed ER+ in 0% of cells.
Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
No prior chemotherapy
Fit for chemotherapy and surgery
Must have the ability to understand and the willingness to sign a written informed consent document.
Must be willing to provide serial blood samples for the study.
Exclusion Criteria:
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Patients with Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Mitch, BSN | Contact | 4126412357 | adamikka2@upmc.edu | |
| Lucia M Borrasso, BSN | Contact | 4126413304 | borrlm@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marija Balic, MD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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circulating free DNA (cfDNA); paired tumor and matched WBC whole genome sequencing
| Up to 2 years |
| ctDNA after surgery treatment | Percentage of patients with ctDNA after surgery and all treatment. | Up to 2 years |
| Event free survival (EFS) | Length of time after primary treatment that the patient remains free of related complications or events. | 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. | Up to 2 years |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |