MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC)
18 Years
N/A
Female
Breast Cancer
Trial Information
MIBG Scintigraphy and Strain Echocardiography in the Detection of Subclinical Cardiovascular Effects One Year After (Neo)Adjuvant Breast Cancer Treatment With Docetaxel, Doxorubicin and Cyclophosphamide (TAC)
Given the lack of data on the incidence of subclinical cardiotoxicity after treatment with
TAC we want to assess whether subclinical cardiovascular damage is present in adult patients
with breast cancer who have completed treatment with (neo)adjuvant TAC one year previously,
using MIBG (meta-iodobenzylguanidine) scintigraphy, novel echocardiographic techniques and
blood biomarkers. Following the study by Lipshultz et al. we expect to find at least in 25%
of the patients signs of subclinical cardiovascular damage with at least one of the three
techniques.(11) If at least 10% is observed we will conclude that it is useful to further
pursue the use of these techniques for the detection of subclinical cardiotoxicity in a next
clinical study which will be powered to assess the predictive value of these techniques for
the development of clinical heart failure. If a lower percentage is observed we will
conclude that it is not useful to further pursue the use of these techniques for the
detection of subclinical cardiotoxicity.
Inclusion Criteria:
- Female patients with breast cancer, ≥ 18 years old at the time of breast cancer
diagnosis
- (Neo)adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide (TAC)
completed one year before inclusion
Exclusion Criteria:
- Evidence of breast cancer recurrence or metastatic disease
- Evidence of heart disease at the time of breast cancer diagnosis
- Evidence of renal failure at the time of cardiac evaluation
- Pregnant or lactating
- Participation in a research protocol with ionizing radiation within one year before
inclusion.
- Evidence of diabetes mellitus or Parkinson's disease
- Evidence of an MIBG-accumulating tumor (pheochromocytoma, paraganglioma,
chemodectoma, ganglioneuroma, neuroblastoma, carcinoid, medullary thyroid cancer,
neurofibromatosis, retinoblastoma, esthesioneuroma, schwannoma, merkelcel-tumor,
pancreatic islet cell tumors, small cell lung carcinoma, melanoma
Type of Study:
Observational
Study Design:
Observational Model: Cohort
Principal Investigator
H.W.M. van Laarhoven, Md
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Medical Centre Nijmegen
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
UMCNONCO201005
NCT ID:
NCT01246856
Start Date:
November 2010
Completion Date:
Related Keywords:
- Breast Cancer
- Cardiotoxicity
- Breast cancer treatment
- MIBG scintigraphy
- Strain Echocardiography
- patients who have been treated with TAC one year previously
- Breast Neoplasms
Name | Location |
|---|
