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

Location:

Jacksonville, Fla.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Female adult patients aged 18+ - Group 1: beginning clinically- indicated chemotherapy for breast cancer with a dose-dense (every 2 weeks) regimen including adriamycin (n=10). - Group 2: patients who receive trastuzumab in and adjuvant, (neo) adjuvant, or metastatic setting in a regimen that does not include simultaneous adriamycin. Exclusion Criteria: - Inability to return to the clinic for regular phlebotomy - Baseline hemoglobin < 10 gm/dl - Creatinine clearance < 60 ml/minute (this effects troponin clearance) - Recent (< 3 months) cardiac surgery, myocardial infarction, unstable angina, or hospitalization for congestive heart failure

Last updated:

1/20/2014

NCT ID:

NCT01771549

IRB Number:

12-007541