Clinical trial NCT01301040 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: epirubicin, cyclophosphamide, docetaxel
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    slow recruitment
  
Eligibility 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.