Clinical trial NCT00562718 (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
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed invasive adenocarcinoma of the breast,
             meeting 1 of the following high-risk criteria:

               -  T3 or T4 primary tumor

               -  4 or more involved axillary lymph nodes (N2 nodal stage)

          -  Completed surgical excision

               -  No immediate reconstruction with autologous flap reconstruction

                    -  Patients having tissue expanders or implants placed prior to radiation may
                       be enrolled at the physician's discretion

          -  No residual breast cancer

               -  Microscopically positive margins are allowed if a re-excision is not felt to be
                  clinically justified

          -  Candidate for radiotherapy

               -  Must not require bilateral radiotherapy

          -  No metastatic (stage IV) breast cancer by AJCC staging criteria

          -  Hormone receptor status not specified

          -  No CNS disorders

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 6 months

          -  Karnofsky performance status 70-100%

          -  Menopausal status not specified

          -  Ambulatory

          -  Hemoglobin > 9 g/dL

          -  Platelet count > 100,000/mm³

          -  ANC > 1,500/mm³

          -  Serum AST, ALT, and alkaline phosphatase ≤ 2 times upper limit of normal (ULN)

          -  Total bilirubin normal

          -  Creatinine clearance > 50 mL/min

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during study and for 30 days after
             the last study drug administration

          -  No serious, uncontrolled, concurrent infection(s)

          -  No diabetes with current or history of delayed wound healing or skin ulcers

          -  No autoimmune connective tissue disorder

          -  No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity
             to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency

          -  No other carcinomas within the last five years except cured non-melanoma skin cancer
             and in-situ cervical cancer

          -  No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic
             coronary artery disease, or cardiac arrhythmias not well controlled with medication)
             or myocardial infarction within the last 12 months

          -  No other serious uncontrolled medical conditions that the investigator feels might
             compromise study participation, including any of the following:

               -  Uncontrolled seizures

               -  Psychiatric disability judged by the investigator to be clinically significant

          -  Physically intact upper gastrointestinal tract

          -  No malabsorption syndrome

          -  No uncompensated coagulopathy

          -  No patients whose breast size or body contour puts them at increased risk for skin
             desquamation from standard radiotherapy

          -  Able to read and speak English

        PRIOR CONCURRENT THERAPY:

          -  Fully recovered from surgery and chemotherapy with completely healed surgical wounds

          -  At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab
             (Herceptin®)

               -  Concurrent trastuzumab allowed at the physician's discretion

          -  More than 4 weeks since prior participation in any investigational drug study

          -  At least 4 weeks since prior and no concurrent sorivudine or brivudine

          -  More than 2 weeks since prior major surgery

          -  No prior capecitabine

          -  No prior radiotherapy to the chest or ipsilateral lymphatics

          -  No concurrent hormonal therapy during course of chemotherapy or radiation therapy

          -  No concurrent allopurinol or cimetidine

          -  Concurrent coumadin is allowed