Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer

A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination With Letrozole as First Line Treatment in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic breast cancer not amenable to curative therapy
• Measurable disease according to the RECIST criteria
• Documented estrogen receptor-positive and/or progesterone receptor-positive tumour
• Postmenopausal women

Exclusion Criteria:

• Prior chemotherapy and/or endocrine therapy for advanced breast disease
• Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in the adjuvant setting
• Unknown hormonal receptor status
• Known HER2/neu-positivity