Clinical trial NCT00296010 (phase 3, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, methotrexate, pegylated liposomal doxorubicin hydrochloride
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, 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
Reason stopped: 
    accrual rate was too low
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Disease must be confined to the breast and axillary nodes without detected masses
                  elsewhere

               -  No history of prior ipsilateral or contralateral invasive breast cancer

          -  Resected disease

               -  No more than 16 weeks since last surgery to remove the tumor

               -  No known clinical residual locoregional disease

               -  Margins must be negative for invasive breast cancer and ductal carcinoma in situ

          -  No locally advanced, inoperable breast cancer including any of the following:

               -  Inflammatory breast cancer

               -  Supraclavicular node involvement

               -  Enlarged internal mammary nodes unless pathologically negative

          -  Synchronous bilateral invasive breast cancer (diagnosed in the past 2 months) allowed
             if all tumors are hormone receptor-negative

          -  Must not be a candidate for endocrine therapy or standard chemotherapy

          -  Hormone receptor-negative disease

        PATIENT CHARACTERISTICS:

          -  Female

          -  Menopausal status: postmenopausal

          -  ECOG performance status 0-2

          -  Platelet count ≥ 100,000/mm^3

          -  Granulocyte count ≥ 1,500/mm^3

          -  WBC ≥ 3,000/mm^3

          -  AST and ALT ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Creatinine clearance ≥ 50 mL/min

          -  Creatinine < 1.35 mg/dL

          -  No significant malabsorption syndrome or disease affecting gastrointestinal tract
             function

          -  No myocardial infarction within the past 6 months

          -  No pulmonary embolism within the past 6 months

          -  No deep vein thrombosis within the past 6 months

          -  No New York Heart Association class III or IV heart disease

          -  LVEF ≥ 50% by echocardiography, radionucleotide ventriculography, or MUGA

          -  No evidence of acute ischemia by ECG

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix or bladder, or ipsilateral
             or contralateral breast carcinoma in situ

          -  No active, uncontrolled infection

          -  No active hepatitis B or C virus infection

          -  No other chronic infection

          -  Patients must not have any of the following "geriatric syndromes":

               -  Dementia

               -  Delirium

               -  Major depression (as diagnosed by a psychiatrist)

               -  Recent falls

               -  Spontaneous bone fractures

               -  Neglect

               -  Abuse

          -  No evidence of medically relevant conduction system abnormalities that would preclude
             study entry

          -  No other nonmalignant, uncontrolled systemic diseases, psychiatric illness, or
             addictive or cognitive disorder that would preclude study participation or compliance

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior raloxifene, tamoxifen citrate, or other selective
             estrogen receptor modulators (SERMs)

          -  No concurrent recombinant human epoetin alfa or pegfilgrastim

          -  No prior neoadjuvant or adjuvant therapy for breast cancer except radiotherapy

          -  Concurrent trastuzumab (Herceptin®) allowed

          -  No concurrent hormonal replacement therapy

          -  No other concurrent hormonal therapy (including estrogen, progesterone, androgens,
             tamoxifen citrate, SERMs, or aromatase inhibitors) except for the following:

               -  Steroids for adrenal failure

               -  Hormones for non-disease-related conditions (e.g., insulin for diabetes)

               -  Intermittent dexamethasone as an antiemetic

          -  No other concurrent investigational agents

          -  No concurrent bisphosphonates, except for the treatment of osteoporosis

          -  For patients who received prior anthracyclines, the following criteria must be met:

               -  Cumulative dose ≤ 240 mg/m² for conventional doxorubicin

                    -  ≤ 140 mg/m² in case of prior doxorubicin and left chest radiotherapy (LCRT)

               -  Cumulative dose ≤ 400 mg/m² for epirubicin

                    -  ≤ 230 mg/m² in case of prior epirubicin and LCRT