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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Fulvestrant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272740

SAKK

9238SZ/0001

21/00

Details and patient eligibility

About

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

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)