NCT00770354

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Antisoma Research · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	AS1402	A complete treatment cycle spans 28 days. Patients randomised to AS1402 will receive a 1-hour infusion of 9 mg/kg on day 1, 8, 15 and 22 of each cycle. Patients will receive letrozole (2.5 mg daily tablet).
DRUG	Letrozole	Daily 2.5 mg oral letrozole tablet

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-08-01
• Completion: 2011-08-01
• First posted: 2008-10-10
• Last updated: 2009-08-10

Locations

2 sites across 1 country: Russia