Breast CancerTOXTACNCT01246856
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
An observational study of Breast Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients who have been treated with TAC one year previously
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Nijmegen
Nijmegen, Gelderland, 6500 HB
H.W.M. van Laarhoven, Md
About this study
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)
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Keywords
- Cardiotoxicity, Breast cancer treatment, MIBG scintigraphy, Strain Echocardiography, patients who have been treated with TAC one year previously
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H.W.M. van Laarhoven, Md, Principal investigator, University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246856
- Sponsor's protocol ID
- UMCNONCO201005
- Acronym
- TOXTAC
- Status last verified
- Sep 2011
- First submitted
- 22 Nov 2010
- Last updated
- 12 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01246856
- Acronym / sponsor ID
- TOXTAC / UMCNONCO201005
- Conditions
- Breast Cancer
- Keywords
- Cardiotoxicity, Breast cancer treatment, MIBG scintigraphy, Strain Echocardiography, patients who have been treated with TAC one year previously
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (estimated)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have been treated with TAC one year previously
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H.W.M. van Laarhoven, Md principal investigator
University Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H.W.M. van Laarhoven, Md (+31 24 361 03 53, h.vanlaarhoven@onco.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2011.