NCT00752986

ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial

A Randomized,Double-blind,Parallel-group,Multicentre,Phase II Study to Evaluate the Safety and Pharmacological Activity of the Combination of Vandetanib (100 or 300 MG/Daily or Placebo)With Fulvestrant (Loading Dose)in Postmenopausal Advanced BC Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..

Detailed description

end-point Efficacy: event-free survival (EFS)

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	ZD6474 (Vandetanib at the dose of 100 mg)	100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
DRUG	Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)	Placebo of 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
DRUG	Fulvestrant	All patients will receive fulvestrant Loading Dose (LD). The Loading Dose regimen is 500mg (2 injections) at day 1, followed by 250mg at day 14, 28 and every 28 days thereafter.
DRUG	ZD6474 (Vandetanib at the dose of 300 mg)	300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.
DRUG	Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)	Placebo of 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2008-09-16
• Last updated: 2016-12-05
• Results posted: 2014-10-06

Locations

11 sites across 1 country: Italy