Clinical trial NCT00118053 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: carboplatin, docetaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer, meeting 1 of the following stage criteria:

               -  Stage IIB (T3, N0)

               -  Stage IIIA (N0-N2)

               -  Stage IIIB (T4, N0-2)

               -  Stage IIIC

               -  Inflammatory breast cancer

          -  HER2/neu-positive disease by fluorescence in situ hybridization

          -  Biopsy-accessible tumor

          -  Measurable disease by physical examination or x-ray

          -  No stage IV disease

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 8 weeks

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Meets 1 of the following criteria:

               -  SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase
                  normal

               -  SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

               -  SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN

          -  Bilirubin normal

        Renal

          -  Creatinine normal

          -  No pre-existing clinically significant renal disease that is not related to the
             malignancy

        Cardiovascular

          -  Ejection fraction ≥ 50% by MUGA

          -  No pre-existing clinically significant cardiac disease that is not related to the
             malignancy

          -  No history of congestive heart failure

        Pulmonary

          -  No pre-existing clinically significant pulmonary disease that is not related to the
             malignancy

        Gastrointestinal

          -  No severe malnutrition

          -  No intractable emesis

        Neurologic

          -  No pre-existing clinically significant neurologic disease that is not related to the
             malignancy

          -  No peripheral neuropathy ≥ grade 2

               -  No nerve damage from diabetes

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective non-hormonal contraception during and for 4 weeks
             after completion of study treatment

          -  No known allergic reaction to study drugs

          -  No active infection

          -  No other malignancy except adequately treated basal cell or squamous cell skin cancer
             or carcinoma in situ of the cervix

          -  No other pre-existing clinically significant disease that is not related to the
             malignancy

          -  No other serious or significant medical condition that would preclude study
             participation

          -  No other contraindication to study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No other concurrent immunotherapy

        Chemotherapy

          -  No prior chemotherapy for the malignancy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy for the malignancy

        Radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  No concurrent surgery for the malignancy

        Other

          -  More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing
             products

          -  No other concurrent investigational or commercial agents or therapies for the
             malignancy