This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant anthracycline / taxane based chemotherapy in patients with breast cancer.
This is a feasibility study evaluating the use of a mathematical model to predict response to standard neoadjuvant chemotherapy in patients with breast cancer. Chemotherapy will be protocol-approved chemotherapy regimen containing intravenous Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel). Patients receive a protocol-approved chemotherapy regimen containing Doxorubicin (or Epirubicin), Cyclophosphamide, and Paclitaxel (or Docetaxel) based on the patient and/or physician preference. Mathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy. Following the completion of neoadjuvant chemotherapy, surgical approach and adjuvant radiation and endocrine therapy are left to the discretion of the treating physicians.
Study Type
OBSERVATIONAL
Enrollment
10
Mathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy.
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path in women with breast cancer undergoing neoadjuvant chemotherapy
To assess the feasibility of using diagnostic needle core biopsy to mathematically predict ƒkill-path (fraction of tumor cells killed calculated using data obtained from histopathology) in 10 women with stage II-III Her2-negative, Estrogen Receptor (ER) positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy. Calculation of patient specific distribution of liver portal radii or characteristic vessel radius (rb), BVF, and the distance that drugs diffuse through tumor tissue (L) and ƒkill-path (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy hematoxylin and eosin (H and E) stained section of diagnostic needle core biopsy specimen. Feasibility of the primary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Time frame: 5 years
Feasibility of calculating tumor BVF from pre-chemotherapy gadolinium enhanced MRI of the breast in women with breast cancer undergoing neoadjuvant chemotherapy
To assess the feasibility of calculating patient specific fraction of blood volume within the tumor (tumor BVF) using data obtained from radiographic imaging (ƒkill-rad) from pre-chemotherapy gadolinium enhanced magnetic resonance imaging (MRI) of the breast in 10 women with stage II-III Her2-negative, ER positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy. Calculation of patient specific BVF (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy gadolinium enhanced MRI of the breast. Feasibility of the secondary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
Time frame: 5 years
Feasibility of calculating ƒkill-rad from pre-chemotherapy gadolinium enhanced MRI of the breast in women with breast cancer undergoing neoadjuvant anthracycline / taxane based chemotherapy
To assess the feasibility of calculating patient specific fraction of tumor cells killed using data obtained from radiographic imaging (ƒkill-rad) from pre-chemotherapy gadolinium enhanced magnetic resonance imaging (MRI) of the breast in 10 women with stage II-III Her2-negative, ER positive or negative infiltrating ductal carcinoma (IDC) of the breast undergoing neoadjuvant anthracycline / taxane based chemotherapy. Calculation of patient specific ƒkill-rad (using the investigators' mathematical model) will be obtained via analysis of pre-chemotherapy gadolinium enhanced MRI of the breast. Feasibility of the secondary objective will be claimed if the necessary minimum samples are collected to calculate these parameters in 60% of patients.
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Time frame: 5 years
Association between ƒkill-path and ƒkill-rad as calculated with the investigator's mathematical model and response to neoadjuvant chemotherapy at the time of surgery
To evaluate the association between fraction of tumor cells killed using data obtained from histopathology (ƒkill-path) and ƒkill-rad as calculated with the investigators' mathematical model and response to neoadjuvant chemotherapy at the time of surgery. The secondary endpoint for describing the association between ƒkillpath and ƒkill-rad is the Spearman correlation coefficient between the two. Endpoints for describing the association between ƒkill-path or ƒkillrad and response will be the mean (SD) and median (Q1-Q3) of ƒkillpath and ƒkill-rad for responders and non-responders. Response will be defined by 1) complete pathologic response (pCR) within the breast and 2) pCR and/or CPS+ EG score \< 2 (3).
Time frame: 5 years
Association between ƒkill-path and ƒkill-rad and biomarkers as calculated with a mathematical model
To evaluate the association between ƒkill-path and ƒkill-rad as calculated with the investigators' mathematical model and biomarkers associated with tumor angiogenesis, metabolism, acid-base regulation, stress response and invasion. The secondary endpoints for describing the association between ƒkill-path and ƒkill-rad and biomarkers associated with tumor angiogenesis, metabolism, acid-base regulation, stress response and invasion are the Spearman correlation coefficients for continuous biomarker measures, or means (SD) and medians (Q1-Q3) of ƒkill-path and ƒkill-rad by levels of categorical biomarkers.
Time frame: 5 years