Know Cancer

forgot password

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.)

Phase 2
65 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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.)

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.

Inclusion Criteria

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

- "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

- 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

- 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

- Signed written informed consent must be given according to ICH-GCP and
national/local regulations, prior to any study specific screening procedures and

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.

Outcome Description:

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.

Outcome Time Frame:

Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.

Safety Issue:


Principal Investigator

Lissandra Dal Lago, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute


Belgium: Ethics Committee

Study ID:

IJB 11-01



Start Date:

March 2011

Completion Date:

March 2016

Related Keywords:

  • Breast Cancer
  • breast cancer, elderly, early cardiac toxicity
  • Breast Neoplasms