Early Cardiac Toxicity of Adjuvant CT in Elderly BC.

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 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.