Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

This is not a treatment trial. Patients will be treated according to the plan developed by
their medical oncologists. Only patients planning to receive anti-HER2 therapy as part of
planned systemic therapy will be eligible for this imaging study. Patients and their
referring oncologist will be asked to start the anti-HER2 therapy 2-3 weeks prior to surgery
and after the pre-therapy MRI.

Inclusion Criteria:

- Women at least 18 years of age.

- Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive.

- Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2
agent.

- Have tissue block available for review of experimental markers.

- Be a candidate for MRI imaging.

- Be willing to comply with scheduled visits required for the trial.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Recent therapy for breast cancer prior to baseline MRI.

- Subjects may not receive other investigational agents during the study window for
imaging.

- Contraindications for MRI or MRI contrast including severe claustrophobia, history of
previous reaction to MRI contrast, renal disease, congestive heart failure, other
significant systemic diseases or any metal in their body, including but not limited
to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or
defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other
implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or
bullet.

- Pregnant or nursing.