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Kinetics of Troponin and BNP in Breast Cancer Chemotherapy With Adriamycin and Trastuzumab

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ClinicalTrials.gov Identifier: NCT01771549
Recruitment Status : Unknown
Verified March 2015 by Joseph L. Blackshear, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
First Posted : January 18, 2013
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have elevations above the detection limit, compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have elevations above the detection limit. Moreover, augmented release of high sensitivity troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in patients with and without coronary artery disease. This improved sensitivity suggests the potential for detection and monitoring of cardiac damage after cancer chemotherapy. We hypothesized that this new generation of troponin assay would be associated with kinetic behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also with trastuzumab.

Condition or disease
Breast Cancer

Detailed Description:

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.


Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of the Kinetics of High Sensitivity Troponin and Brain Natriuretic Peptide in Breast Cancer Chemotherapy With Adriamycin and Trastuzumab
Study Start Date : January 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Group 1
Patients with breast cancer beginning chemotherapy with a dose-dense regimen including adriamycin without concurrent trastuzumab.
Group 2
Patients receiving trastuzumab in the adjuvant, neo-adjuvant, or metastatic setting in a regimen not containing simultaneous adriamycin therapy.


Outcome Measures

Primary Outcome Measures :
  1. Area under the curve [ Time Frame: one year ]
    Concentration-time plots from pre-treatment through days 1,2,3,7,and pre-cycle two


Secondary Outcome Measures :
  1. Baseline to peak [ Time Frame: 1 year ]
    The difference between the pretreatment value and the highest level on days 1,2,3 or 7


Other Outcome Measures:
  1. Descriptive statistics [ Time Frame: 1 year ]
    Descriptive statistics will be used to describe the quantitative values, and frequencies above and below the detection limit, time to peak, and amplitude of peak versus baseline values for both n-t-BNP and hs-cTnT.


Biospecimen Retention:   Samples Without DNA
Whole blood 10 ml per draw, yielding 5 ml of serum. After testing, the remaining serum will be stored.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic Florida female, adult patients from Hematology/Oncology Department undergoing clinically-indicated treatment for breast cancer which includes either, but not both, adriamycin or trastuzamab will be eligible to participate
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771549


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Joseph L Blackshear, M.D. Mayo Clinic
More Information

Responsible Party: Joseph L. Blackshear, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01771549     History of Changes
Other Study ID Numbers: 12-007541
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Joseph L. Blackshear, Mayo Clinic:
Adriamycin
Trastuzumab
Brain Natriuretic Peptide (BNP)
Troponin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Trastuzumab
Doxorubicin
Natriuretic Peptide, Brain
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs