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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

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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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Area under the curve

Outcome Description:

Concentration-time plots from pre-treatment through days 1,2,3,7,and pre-cycle two

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Joseph L Blackshear, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-007541

NCT ID:

NCT01771549

Start Date:

January 2013

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • Adriamycin
  • Trastuzumab
  • Brain Natriuretic Peptide (BNP)
  • Troponin
  • Breast Neoplasms

Name

Location

Mayo ClinicJacksonville, Florida  32224