Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.)
Overview
- Phase
- Phase 2
- Intervention
- epirubicin, cyclophosphamide, docetaxel
- Conditions
- Breast Cancer
- Sponsor
- Jules Bordet Institute
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief 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).
Detailed Description
Considering that both anthracycline-based and Taxotere-cyclophosphamide CT have established efficacy in the adjuvant treatment of elderly patients with early breast cancer, and the paucity of data for early cardiac toxicities with anthracycline-based adjuvant therapy compared to non-anthracycline regimen, this is the first randomized study to evaluate early cardiac signs based on doppler myocardial imaging (DMI). The results of this study could improve the monitoring of the cardiac function of elderly patients candidates to receive adjuvant chemotherapy for early breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Epirubicin/Cyclophosphamide
Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles
Intervention: epirubicin, cyclophosphamide, docetaxel
docetaxel/cyclophosphamide
Treatment Arm 2: TC - docetaxel (Taxotere) (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
Intervention: epirubicin, cyclophosphamide, docetaxel
Outcomes
Primary Outcomes
The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.
Time Frame: Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.
The primary null hypothesis is that the means are equal versus the alternative hypothesis that the means are different. We plan to perform the comparison using a two-sided Student's t-test with α=5%. The power of the study to detect the difference described below has been set at 90%. One hundred twenty patients candidate to receive neoadjuvant or adjuvant CT for early BC will be randomized 1:1 to receive either epirubicin-cyclophosphamide (EC) or docetaxel (Taxotere) -cyclophosphamide (TC) for 4 cycles.