Conditions: Breast Cancer
Keywords: ZD6474 Vandetanib Zactima Fulvestrant Faslodex Breast Cancer Advanced, Metastatic Hormone Receptor Positive Post-Menopausal Patients post-menopausal women with hormone receptor positive advanced breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief 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)

Arms:
arm 1: vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3) arm 2: vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3) arm 3: placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).

Interventions: intervention 1: ZD6474 (Vandetanib at the dose of 100 mg) intervention 2: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) intervention 3: Fulvestrant intervention 4: ZD6474 (Vandetanib at the dose of 300 mg) intervention 5: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Intervention descriptions: intervention 1: 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first intervention 2: 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 intervention 3: 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. intervention 4: 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first. intervention 5: 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

Protocol document: