Trial Information

Pilot Study of the Kinetics of High Sensitivity Troponin and Brain Natriuretic Peptide in Breast Cancer Chemotherapy With Adriamycin and Trastuzumab

Collect blood samples in two groups of patients (n=10 per group) for amino-terminal brain
natriuretic peptide (n-t-BNP) and high sensitivity cardiac troponin T (hs-cTnT):

- Group 1 (adriamycin) will consist of patients beginning clinically indicated
chemotherapy for breast cancer with a dose-dense (every 2 week) regimen. including
adriamycin (n=10).

- Group 2 will include patients who receive trastuzumab in the adjuvant or (neo) adjuvant
setting, or in a metatstatic setting in a regimen that does not include simultaneous
adriamycin.

Blood samples for hs-cTNT and n-t-BNP will be obtained on days pre-treatment, and
post-treatment days 1, 2, 3, 7, pre-cycle 2, and post-cycle 2 days 1,2,3 and 7. The interval
for treatment is usually two weeks for adriamycin and three weeks for trastuzumab. We will
identify frequency of detectible levels above the detection limit and above the baseline,
peak values and area under the curve. Enrollment of up to 15 per group will be allowed to
guarantee acquisition of 10 full sets of samples. Lab draw from chemotherapy ports will be
allowed. We plan to store specimens for future analyses with more sensitive assays in
development.