Mathematical Modeling to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer

Inclusion Criteria:

Women with newly diagnosed human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor (ER) positive or negative, progesterone receptor (PR) positive or negative infiltrating ductal carcinoma (IDC) of the breast
Clinically stage II-III
Patients with inflammatory, multifocal, multicentric and synchronous bilateral breast cancers are allowed. However, in patients with inflammatory breast cancer, patients must have a measurable, biopsied mass within the breast pre-chemotherapy.
Willing and able to provide informed consent
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1

Patients must be able to receive neoadjuvant anthracycline / taxane based chemotherapy in the opinion of the treating physician. Criteria include:

Adequate bone marrow function, as defined by peripheral granulocyte count of ≥ 1,500/mm3, and platelet count ≥100,000/mm3
Adequate renal function with creatinine levels ≤ 1.5 X the upper limit of normal and estimated glomerular filtration rate (eGFR) >30.
Adequate liver function with a bilirubin, Alkaline phosphatase and transaminases (ALT and AST) of ≤ 1.5 X the institutional upper limit of normal.
Multigated acquisition (MUGA) or echocardiogram (ECHO) demonstrating a left ventricular ejection fraction (LVEF) within institutional normal limits
Women of reproductive potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Patients may also co-enroll in trials that compare local therapies, or compare systemic adjuvant therapies.
Patients must have had (or be scheduled to have) a pre neoadjuvant chemotherapy MRI of the breast with gadolinium contrast as part of their planned routine breast cancer care.

Exclusion Criteria:

Patients must not have had surgery or radiation or begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen.
Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI.
History of severe claustrophobia
History of allergic reaction to gadolinium
Patients must not have metastatic disease
Baseline sensory/motor neuropathy > grade 2
Clinically significant cardiovascular disease
Serious intercurrent infection or nonmalignant medical illness
Creatinine clearance prohibiting the use of gadolinium (eGFR < 30)