SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer

An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors

The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate

Inclusion Criteria:

• Histological/cytological confirmation of breast cancer
• progression under treatment with an aromatase inhibitor
• At least one measurable or non-measurable lesion

Exclusion Criteria:

• Prior treatment for breast cancer with more than 2 different hormonal agents
• More than 1 chemotherapy for advanced disease
• Presence of life-threatening metastatic visceral disease