Diagnosis and Prediction of Taxanes Induced Cardiac Dysfunction

NCT01641562 | Completed DMC

• 2 other identifiers: 4192910112/27.10.2011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer represents the most frequent form of neoplasia in women worldwide, being responsible of 1.6% of annual deaths. Therefore, it is a major public health issue and research in this field should be a priority. Taxanes, such as paclitaxel and docetaxel, are extremely powerful antineoplastic drugs, which alone or in association to anthracyclines, increase survival and lower the recurrence rate of cancer, but their use is limited by cardiotoxicity. Cardiotoxicity can appear early or late after therapy, and may vary from subclinical myocardial dysfunction to irreversible heart failure. Currently, cardiac dysfunction induced by taxanes is diagnosed through classical echocardiographic parameters. However, these cannot detect subtle, early changes of cardiac structure and function. Consequently, description of new parameters, which could detect cardiac dysfunction in an early stage, becomes essential for detecting the group of patients at risk for irreversible heart failure. The objectives of the investigators project, in patients with breast cancer treated with taxanes, are to investigate their mechanisms which lead to cardiac dysfunction, to describe new parameters for the early diagnosis of cardiotoxicity, and to define predictive models for cardiotoxicity. Meanwhile, project will publish the results in prestigious journals, leading to an increase of the visibility of Romanian research internationally.

Conditions

Breast Cancer

Keywords

BREAST CANCER,; TAXANES,; SUBCLINICAL CARDIAC DYSFUNCTION ,; DIAGNOSTIC TOOLS,; PREDICTIVE MODELS

Outcome Measures

Primary Outcomes (1)

• CARDIOTOXICITY PREDICTION SCORE

  To determine the change in left ventricular ejection fraction (LVEF) after 6 months, 1 or 2 years after treatment with taxanes for defining cardiotoxicity (LVEF less than 55% or reduction with more than 10% from baseline).

  6 MONTHS, 1 YEAR, 2 YEARS

Secondary Outcomes (3)

• GENETIC DISORDERS AND CARDIOTOXICITY

  BASELINE

• DIAGNOSTIC ACCURACY FOR CARDIOTOXICITY

  2 YEARS

• EVALUATION PROTOCOL FOR CARDIOTOXICITY

  2 YEARS

Study Arms (1)

TAXANES

patients with early breast cancer, scheduled to receive taxanes, with doses according to the stage of the disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study will include 60 patients with early breast cancer, scheduled to receive taxanes, in monotherapy (30 patients) or associated to anthracyclines (30 patients), with doses according to the stage of the disease.

You may qualify if:

• Age over 18 years
• Informed consent signed
• Patients with early breast cancer, scheduled to receive chemotherapy
• LVEF \> 50% and LVSF \> 20%.

You may not qualify if:

• Any history of cardiovascular disease and/or active cardiovascular treatment
• Diabetes mellitus
• Mediastinal irradiation.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

University and Emergency Hospital

Bucharest, 050098, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biomarkers: brain natriuretic peptides, troponin T, markers of myocardial fibrosis (β cross laps and procollagen type-1 amino terminal), and markers of inflammation (PCR-hs, IL1, IL6, IL 10, TNFalpha). Markers of the oxidative stress: concentration of carbonyl in plasmatic proteins, and the antioxidant capacity of plasma. Genetic tests of susceptibility to cardiotoxicity: genomic DNA extraction kit/DNA quantification tests/PCR tests.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• DRAGOS VINEREANU, MD

  UNIVERSITY AND MEDICINE CAROL DAVILA BUCHAREST

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 17, 2012
• Study Start: January 1, 2012
• Primary Completion: October 30, 2016
• Study Completion: January 31, 2017
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

RO (1)