Clinical trial NCT00107276 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: capecitabine, cyclophosphamide
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed stage IV breast cancer

               -  Metastatic disease (M1) OR multiple sites of new disease that is clinically
                  obvious metastatic disease (i.e., multiple sites of new osseous disease)

          -  Meets 1 of the following criteria:

               -  Measurable disease

               -  Non-measurable disease

                    -  MUC-1 antigen level > 2 times upper limit of normal AND level has increased
                       by 1.5 times

          -  Must have documented MUC-1 antigen level

               -  Either cancer antigen (CA) 15-3 or CA 27-29 allowed

          -  Must have received at least 1 prior hormonal therapy for metastatic disease (estogen
             receptor-positive patients only)

          -  No symptomatic brain or CNS metastases

               -  Previously treated brain or CNS metastasis allowed provided radiotherapy was
                  completed ≥ 8 weeks before study entry

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  No known existing uncontrolled coagulopathy

        Hepatic

          -  Not specified

        Renal

          -  Creatinine clearance > 40 mL/min

        Cardiovascular

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No cardiac arrhythmia not well controlled with medication

          -  No myocardial infarction within the past 12 months

          -  No other clinically significant cardiac disease

        Gastrointestinal

          -  Able to take oral medication

          -  No uncontrolled nausea, vomiting, or diarrhea

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No active infection requiring systemic therapy

          -  No prior severe reaction to fluoropyrimidines

          -  No known sensitivity to fluorouracil

          -  No known dihydropyrimidine dehydrogenase deficiency

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy or biologic therapy for breast cancer

          -  No concurrent gene therapy for breast cancer

          -  No concurrent filgrastim (G-CSF)

        Chemotherapy

          -  At least 14 days since prior chemotherapy and recovered

          -  No more than 2 prior chemotherapy regimens for metastatic disease

          -  No prior capecitabine for metastatic disease

          -  No prior oral cyclophosphamide for metastatic disease

               -  Prior IV cyclophosphamide allowed

          -  No other concurrent chemotherapy for breast cancer

        Endocrine therapy

          -  See Disease Characteristics

          -  No concurrent hormonal therapy for breast cancer

        Radiotherapy

          -  See Disease Characteristics

          -  At least 14 days since prior radiotherapy to non-CNS disease sites and recovered

          -  No concurrent radiotherapy for breast cancer

        Surgery

          -  Not specified

        Other

          -  Concurrent bisphosphonates allowed

          -  No concurrent full-dose warfarin

               -  Concurrent prophylactic warfarin (≤ 1 mg/day) to maintain port patency allowed

          -  No other concurrent antineoplastic therapy for breast cancer