Clinical trial NCT00036868 (phase 2, status: unknown status)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cmf regimen, cyclophosphamide, fluorouracil, methotrexate
SMILES: FC1=CNC(=O)NC1=O, ClCCN(CCCl)P1(=O)NCCCO1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed metastatic breast cancer c-erbB2 positive (3+ overexpression
             by the HercepTest™ method) in the primary tumor or metastatic site

          -  At least 1 unidimensionally measurable target lesion

               -  At least 20 mm by conventional techniques OR

               -  At least 10 mm by spiral CT scan

               -  Lesions that have been irradiated in the preceding 3 months cannot be used as
                  target lesions unless they have appeared or clearly progressed since prior
                  irradiation

               -  No bone lesions as the only target lesions

          -  No contralateral breast cancer that is c-erbB2-positive or c-erbB2-negative/unknown,
             with status determined on a metastatic site

          -  No CNS metastases

               -  CT scan of brain and CSF cytology are required if neurologic symptoms are present

          -  Hormone receptor status:

               -  Any estrogen or progesterone receptor status

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Sex:

          -  Female

        Menopausal status:

          -  Any status

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.25 times upper limit of normal (ULN)

          -  Transaminases less than 2.5 times ULN (5 times ULN if liver metastases present)

        Renal:

          -  For patients age 18 to 69:

               -  Creatinine no greater than ULN

          -  For patients age 70 and over:

               -  Creatinine clearance normal

        Cardiovascular:

          -  LVEF normal by MUGA or echocardiogram

          -  No clinical heart failure

        Pulmonary:

          -  No malignancy-associated dyspnea at rest

          -  No requirement for supportive oxygen therapy

        Other:

          -  Not pregnant or nursing

          -  No other prior or concurrent malignancy within the past 5 years except adequately
             treated carcinoma in situ of the cervix or basal cell skin cancer

          -  No psychological, familial, sociological, or geographical condition that would
             preclude compliance with study therapy and follow-up schedule

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior anti-c-erbB2 antibody, including trastuzumab (Herceptin®)

          -  No other concurrent biologic therapy

        Chemotherapy:

          -  No more than 1 prior chemotherapy regimen for metastatic breast cancer

          -  Prior combination of cyclophosphamide, methotrexate, and fluorouracil (CMF) allowed in
             the adjuvant or metastatic setting only if the disease-free interval after completion
             of CMF was at least 12 months

          -  Prior anthracyclines and/or taxanes allowed

          -  At least 4 weeks since prior anthracyclines

          -  No prior cumulative dose of doxorubicin more than 360 mg/m^2

          -  No prior cumulative dose of epirubicin more than 720 mg/m^2

          -  No prior cumulative dose of mitoxantrone more than 90 mg/m^2

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  More than 2 weeks since prior hormonal therapy in the adjuvant or metastatic setting

          -  No concurrent hormonal therapy

        Radiotherapy:

          -  See Disease Characteristics

          -  No concurrent radiotherapy

        Surgery:

          -  Not specified

        Other:

          -  No other concurrent anticancer therapy or investigational drugs

          -  No concurrent bisphosphonates started after study enrollment except for hypercalcemia