Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

• Drug: SU011248
  SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
  Other Name: Sutent, sunitinib malate
• Drug: Chemotherapy

  The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.

  1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
  2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
  3. Docetaxel - 75-100 mg/m2 every 3 weeks
  4. Paclitaxel - 175-200 mg/m2 every 3 weeks
  5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
  6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.

• Experimental: A
  Intervention: Drug: SU011248
• Active Comparator: B
  Intervention: Drug: Chemotherapy

Inclusion Criteria:

• Recurrent or metastatic breast cancer
• Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
• Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
• Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion Criteria:

• More than two chemotherapy regimens for advanced disease
• Uncontrolled/symptomatic spread of cancer to the brain