Clinical trial NCT00424203 (phase 2, status: completed)
Conditions: breast cancer, cognitive/functional effects, depression, malnutrition, psychosocial effects of cancer and its treatment
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, F32.A, F53.0, P91.4, Z13.31, Z13.32, O25.2, E44.0, E44.1, E46, O25.3, E43, E64.0
Drugs: ac regimen, cyclophosphamide, doxorubicin hydrochloride
SMILES: CCO, ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive adenocarcinoma of the breast

               -  Stage I, II or III disease

                    -  pN+ or pN0 with grade III disease (tumor size ≥ 2 cm)

                    -  No metastatic disease

          -  Must have undergone prior conservative or radical surgery that included axillary lymph
             node or sentinel node dissection

               -  No residual tumor

               -  Negative margins

          -  Hormone receptor status:

               -  Estrogen receptor and progesterone receptor negative

        PATIENT CHARACTERISTICS:

          -  Female

          -  Postmenopausal

          -  Absolute neutrophil count > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Hemoglobin > 10 g/dL

          -  Alkaline phosphatase < 2.5 times upper limit of normal (ULN)

          -  Bilirubin < 1.25 times ULN

          -  AST and ALT < 2.5 times ULN

          -  Creatinine clearance ≥ 40 mL/min

          -  No contraindication to receiving anthracyclines or alkalizing agents

          -  FEV normal

          -  Activities of Daily Living (ADL) score ≥ 5

               -  No decrease of ≥ 1 point within the past 3 months

          -  None of the following at baseline:

               -  Cognitive deficiency (Folstein Mini-Mental State < 25)

               -  Severe depression (Geriatric Depression Scale ≥ 20)

               -  Severe malnutrition (Mini-Nutritional Assessment ≤ 17)

          -  No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics
             grade 3-4), including any of the following:

               -  Cardiac insufficiency

               -  Unstable angina

               -  Myocardiopathy

               -  Myocardial infarction within the past year

               -  Uncontrolled hypertension

               -  Uncontrolled high-risk arrhythmia

               -  Severe medullary insufficiency

               -  Neurological or psychological condition that would preclude study consent

               -  Uncontrolled or active infection

               -  Severe urinary tract infection

               -  Preexisting hematuria

               -  Active ulcer

               -  Uncontrolled diabetes

          -  No other cancer within the past 5 years except for basal cell skin cancer or carcinoma
             in situ of the cervix

          -  No familial, geographical, social, or psychological condition that would preclude
             study participation

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 60 days since prior therapeutic surgery

          -  At least 4 weeks since prior investigational drugs