Early Cardiac Toxicity of Adjuvant CT in Elderly BC. (NCT01301040) | Clinical Trial Compass
TerminatedPhase 2
Early Cardiac Toxicity of Adjuvant CT in Elderly BC.
Stopped: Slow recruitment
Belgium2 participantsStarted 2011-03
Plain-language summary
The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.
This study also will compare the serum biomarkers profile during and after the (neo) adjuvant CT in both treatment arms, assess whether MRI allows detecting earlier than standard echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess whether brain PET-CT allows detecting regional functional impairment in patients receiving CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms, evaluate distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate psychological state and burden of primary caregivers before and after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the Framingham risk score for Hard Coronary Heart Disease (10-year risk).
Who can participate
Age range
65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. Patient selection criteria
* Female aged equal or more than 65 years.
* Histological diagnosis of early BC for which the treating physician considers (neo) adjuvant chemotherapy to be beneficial. Recommended situations are:
* Triple negative BC if pT \> 1cm.
* HER-2 positive BC if pT1 \> 1cm; and trastuzumab will be given after study chemotherapy.
* "Luminal B" cancers defined as ER+, PgR + or neg, Ki-67 ≥ 14%, and pT1 \> 1cm.
* "Luminal A" cancers (ER+, PgR+ and Ki-67 \< 14%) will be considered only if ≥ 4 nodes.
* Poor response to a preoperative endocrine therapy.
* WHO performance status equal or less than 1.
* Baseline LVEF equal or more than 50% measured by echocardiography.
* Adequate organ function including:
* neutrophils more or equal to 1.5 x 109/L.
* platelets more or equal to100 x 109/L.
* bilirubin \< 1.25 x upper limit of normal (ULN) for the institution.
* transaminases: AST \< 2.5 x ULN , ALT \< 2.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN for the institution.
* Estimated creatinine clearance \> 30ml/min (using the Crockoft and Gault formula) (See Appendix E) .
* No previous exposure to chemotherapy in this neoadjuvant or adjuvant setting.
* No serious cardiac illness or medical conditions as judged by the investigator including, but not confined to:Symptomatic ventricular arrhythmias,Clinical and/or ECG evidence of myocardial infarction within the last 12 months,Coronary artery disease requiring medicat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.
Timeframe: Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.