Community Hospital Identification of High CV Risk Patients During Cancer Treatment

While recent research indicates that conventional MRI, advanced echocardiography (global
longitudinal strain and 3D) and serum biomarkers can detect CV injury early after receipt of
Chemotherapy, these methods require lengthy and difficult examinations that are not routinely
executed in community hospitals where the majority of patients with BrC & lymphoma are
treated. Yet, 1-month deteriorations in traditional 45-min MRI measures are known to forecast
6-month subclinical deteriorations in left ventricular ejection fraction (LVEF) that are
associated with CV events. At the same time, new observational data indicate therapy with
HMG-CoA reductase inhibitors/statins administered early during receipt of Chemotherapy may
prevent subsequent cardiac dysfunction and CV events. Our MRI fast scanning techniques remedy
these community hospital implementation obstacles.

In this proposal, the investigators propose to test the utility of these fast scans within an
existing funded randomized clinical trial R01HL118740 of generic atorvastatin that is
researching methods to prevent cardiotoxicity in patients treated with Chemotherapy for BrC
and lymphoma (taking advantage of significant existing clinical trial resources). This study
allows us to address our over-arching goal: to determine the optimal implementation (alone or
in combination with other tests) of our proprietary MRI processes for forecasting CV injury
in patients treated with Chemotherapy in community hospitals through performance of a Phase
II comparative effectiveness study within an ongoing clinical trial.

Inclusion Criteria:

- Newly diagnosed Stage I-III breast cancer (including inflammatory and newly diagnosed
recurrent breast cancer) or lymphoma with a > 2 year life expectancy

- Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)

- = or > 21 years of age

- Prior cancers allowed if no evidence of disease

- ECOG 0 or 1

- Enrollment in NCI Protocol #: WF 98213. Patients must receive Fast MRI and 3D ECHO
along with Baseline (98213) MRI prior to first chemotherapy treatment.

Exclusion Criteria:

- Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial
metal; pacemakers, defibrillators, functioning neurostimulator devices or other
implanted electronic devices.

- Most breast tissue expanders are not allowed. (If uncertain, inform the MRI tech to
confirm eligibility status.)

- Unable to provide informed consent

- Symptomatic Claustrophobia

- Pregnant or breasting feeding. Due to unknown risks and potential harm to the unborn
fetus a negative serum pregnancy test within 10 days prior to registration is required
in patients with child-bearing potential. For this reason patients of child-bearing
potential must agree to use adequate contraception (hormonal or barrier method of
birth control; abstinence (not having sex), oral contraceptives, intrauterine device
(IUD), DeProvera, tubal ligation, or vasectomy of the partner (with confirmed negative
sperm counts) in a monogamous relationship (same partner). An acceptable, although
less reliable method involves the careful use of condoms and spermicidal foam or gel
and/or cervical cap or sponge prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her study physician immediately.