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): a Pilot Study

Breast Cancer Clinical Trial

— TOXTAC  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01246856
• Other study ID #: UMCNONCO201005
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2010
• Last updated: September 9, 2011
• Start date: November 2010

Study information

• Verified date: September 2011
• Source: Radboud University
• Contact: H.W.M. van Laarhoven, Md
• Phone: +31 24 361 03 53
• Email: h.vanlaarhoven[@]onco.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Many patients with breastcancer in the past, were treated with TAC. These last years, there is more and more focus on the effects of chemotherapy, particularly in children treated with this. One of these effects is damage to the heart muscle, which ultimately might affect the pump-function of the heart . In adults, the effect of treatment with TAC on the heart, has not been previously investigated. The possibility exists that the adverse reactions in children are found in adults also could occur. Therefore we have initiated this trial.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Netherlands	University Medical Centre Nijmegen	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands,