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Early Cardiac Toxicity of Adjuvant CT in Elderly BC.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01301040
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 23, 2011
Last Update Posted : August 30, 2013
Information provided by (Responsible Party):
Jules Bordet Institute

February 18, 2011
February 23, 2011
August 30, 2013
March 2011
March 2013   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01301040 on Archive Site
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Early Cardiac Toxicity of Adjuvant CT in Elderly BC.
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.)

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).

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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Breast Cancer
Drug: epirubicin, cyclophosphamide, docetaxel
  • Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
  • Treatment Arm 2: TC - docetaxel (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
Other Names:
  • Docetaxel: Taxotere
  • Cyclophosphamide: Endoxan
  • Epirubicin: Epirubicin Teva
  • Active Comparator: Epirubicin/Cyclophosphamide
    Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles
    Intervention: Drug: epirubicin, cyclophosphamide, docetaxel
  • Active Comparator: docetaxel/cyclophosphamide
    Treatment Arm 2: TC - docetaxel (Taxotere) (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
    Intervention: Drug: epirubicin, cyclophosphamide, docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2016
March 2013   (Final data collection date for primary outcome measure)
  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 medication,High-risk uncontrolled arrhythmias,Poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg).
    • Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness.
    • No participation to other clinical trials involving therapeutic agents within the 6 weeks prior to the randomization.
    • No prior or concurrent diagnosis of cancer, except for adequately treated basocellular and squamous cell carcinoma of the skin or cervical uterine in situ tumor
    • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    • Signed written informed consent must be given according to ICH-GCP and national/local regulations, prior to any study specific screening procedures and randomization.
  2. Caregiver selection criteria

    • to be identified by participating patients as their primary caregivers i.e the person who helps them the most to cope with cancer in their everyday life
    • to be at least eighteen years old
    • to be aware of the cancer diagnosis of the patients to be fit enough to complete the questionnaires
    • to be French speaking
    • to be free of any cognitive dysfunction.
    • to give their written informed consent as regards participation in the study.
Sexes Eligible for Study: Female
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
IJB 11-01
2011-000562-35 ( EudraCT Number )
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Jules Bordet Institute
Jules Bordet Institute
Principal Investigator: Lissandra Dal Lago, MD Jules Bordet Institute
Principal Investigator: Evandro De Azambuja, MD Jules Bordet Institute
Jules Bordet Institute
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP