Imaging Biomarker for Early Detection of Treatment Efficacy During Breast Cancer Neoadjuvant Chemotherapy

This trial has a two-step, sequential design, with continuation to the second part of the
trial being dependent on the positive results in the first part. In Part One of the trial,
the investigator will compare intrapatient variability in fDM performed at two timepoints
prior to chemotherapy (chemotherapy will be chosen by the treating physician and will not be
assigned as part of this study), with the change in fDM before and approximately one week
after a dose of chemotherapy, to establish that treatment-related changes in fDM will occur
in this clinical setting. If there are positive results in Part One, then the investigator
will proceed to the second half of the trial. In Part Two, the investigator will examine
changes in fDM that occur one week after each type of chemotherapy is administered, which
will be compared to pathologic response, radiological response, and clinical response.

Inclusion Criteria:

- Patients must have a primary measurable, biopsy proven, invasive breast carcinoma
with the primary tumor intact. The tumor should be staged clinically as T2-T4
(minimum size >2.0 cm).

- Patients must have a breast tumor that is resectable or potentially resectable
following neoadjuvant chemotherapy and be willing to undergo resection, if indicated,
after chemotherapy.

- Patients may not have received prior chemotherapy or radiation therapy for their
current breast cancer.

- Patients may not have had a clip placed into the tumor that is not compatible with
MRI.

- Patients must be deemed eligible for neoadjuvant chemotherapy, as assessed by the
clinical investigator.

- Age > 18 years.

- Patients must have an ECOG performance status (Eastern Cooperative Oncology Group
Performance Status: an attempt to quantify cancer patients' general well-being and
activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5
is death.) of 0 - 1.

- Patients must not be pregnant or breast-feeding. Patients with reproductive potential
must consent to the use of effective contraception while on the study.

- Patients must have no contraindications to MRI (Magnetic Resonance Imaging) exams.
Patients who require sedation with general anesthesia to complete an MRI are not
eligible for the study.

- Patients may have no ferrous metal implants or medical devices which would exclude
MRI.

- Patients must be capable of lying flat in an MRI magnet for 30-60 minutes on 4
occasions.

- Weight must be less than 275 pounds.

- Patients must have the ability to understand and willingness to sign a written
informed consent document.