Vascular and Cognitive Assessments in Patients With Breast Cancer Undergoing Chemotherapy After Surgery

PRIMARY OBJECTIVES:

I. To assess the feasibility of enrolling women who are receiving adjuvant chemotherapy for
breast cancer to a clinical trial with assessments of vascular function and cognition before
and after adjuvant chemotherapy and to obtain pilot data on outcomes that will be used in
future larger-scale trials.

SECONDARY OBJECTIVES:

I. Evaluate the presence, duration, and severity of brain circulation changes identified with
transcranial Doppler ultrasound (TCD) after adjuvant chemotherapy for breast cancer.

II. Assess the changes in flow-mediated dilation (FMD) and aortic dilation that occur after
adjuvant chemotherapy for breast cancer.

III. Assess for correlation between the presence of brain circulation and vascular changes
and performance on neuropsychological testing and the Functional Assessment of Cancer
Therapy-Cognitive Scale (FACT-Cog).

OUTLINE:

Patients undergo TCD examination including bilateral evaluation of standard intracranial
arterial segments including the M1 and M2 segments of the middle cerebral artery (MCA), the
anterior cerebral artery (ACA) and posterior (PCA) cerebral artery, via the transtemporal
acoustic windows, the internal carotid artery (ICA) siphon via transorbital approach, and the
vertebral and basilar arteries (proximal, mid, and distal) via the suboccipital approach.
Patients also undergo magnetic resonance imaging (MRI). All tests occur between 21 days after
completion of surgery and up to 30 days prior to adjuvant chemotherapy and between 20-60 days
after completion of adjuvant chemotherapy.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed non-metastatic breast
cancer; stages 1-3 are acceptable

- Patients must be candidates for either neoadjuvant or adjuvant chemotherapy for breast
cancer

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

Exclusion Criteria:

- Patients who have had prior systemic chemotherapy are not eligible for the study

- Patients who are scheduled to receive trastuzumab and/or bevacizumab are not eligible

- Patients who are on dialysis

- Women who are pregnant are not eligible due to unknown risks and potential harm to the
unborn fetus

- Patients with metastatic breast cancer are not eligible