A Study of Avastin (Bevacizumab) in Combination With Neoadjuvant Treatment Regimens in Patients With Primary HER2 Negative Breast Cancer

This 2 arm study will evaluate the effect of Avastin, in combination with chemotherapy or endocrine therapy, as preoperative treatment in patients with HER2 negative breast cancer. Patients will be randomized to receive either chemotherapy (FEC100 for 4 x 3weekly cycles or endocrine therapy (an aromatase inhibitor daily for 24 weeks)with or without Avastin (15mg/kg iv every 3 weeks).The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

• Drug: bevacizumab [Avastin]
  15mg/kg iv every 3 weeks
• Drug: Placebo
  iv every 3 weeks
• Drug: Standard chemotherapy or endocrine therapy
  As prescribed

• Experimental: 1
  Interventions:

  • Drug: bevacizumab [Avastin]
  • Drug: Standard chemotherapy or endocrine therapy
• Placebo Comparator: 2
  Interventions:

  • Drug: Placebo
  • Drug: Standard chemotherapy or endocrine therapy

Inclusion Criteria:

• adult patients, >=18 years of age;
• HER2-negative breast cancer, >=2.5cm in size;
• ECOG/WHOperformance status <=2;
• normal baseline cardiac function (LVEF).

Exclusion Criteria:

• stage IV (metastatic) disease;
• previous treatment for localized breast cancer < 24 months from diagnosis of present breast cancer;
• other previous or current cancer except for basal cell cancer or in situ cervical cancer;
• current or recent use of aspirin (>325mg/day);
• clinically significant cardiovascular disease.