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

NCT01771549 | Completed

• 1 other identifier: 12-007541
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Adriamycin; Trastuzumab; Brain Natriuretic Peptide (BNP); Troponin

Outcome Measures

Primary Outcomes (1)

• Area under the curve

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

  one year

Secondary Outcomes (1)

• Baseline to peak

  1 year

Other Outcomes (1)

• Descriptive statistics

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Advani P, Hoyne J, Moreno-Aspita A, Dubin M, Brock S, Harlow C, Chumsri S, Suter T, Blackshear JL. High-Sensitivity Troponin T and NT-proBNP Kinetics in Breast Cancer Chemotherapy. Chemotherapy. 2017;62(6):334-338. doi: 10.1159/000477797. Epub 2017 Jul 14.

  PMID: 28704807 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood 10 ml per draw, yielding 5 ml of serum. After testing, the remaining serum will be stored.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joseph L Blackshear, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (1)