ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
Phase 2
Terminated
- Conditions
- Breast Cancer
- Interventions
- Drug: ZD6474 (Vandetanib at the dose of 100 mg)Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)Drug: ZD6474 (Vandetanib at the dose of 300 mg)Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
- Registration Number
- NCT00752986
- Lead Sponsor
- Genzyme, a Sanofi Company
- 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)
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 39
Inclusion Criteria
- Post menopausal women with locally advanced or metastatic breast cancer
- Patients may have either measurable or non-measurable disease, as defined by RECIST criteria
- One previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
- estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or secondary tumour
Exclusion Criteria
- Hormone receptor negative tumours (ER and PR negative)
- Presence of life-threatening metastatic visceral disease
- Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
- History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vandetanib at the dose of 100 mg ZD6474 (Vandetanib at the dose of 100 mg) 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) Vandetanib at the dose of 300 mg ZD6474 (Vandetanib at the dose of 300 mg) 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) Vandetanib at the dose of 100 mg Placebo to match ZD6474 (Vandetanib at the dose of 300 mg) 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) Vandetanib at the dose of 300 mg Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) 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) Placebo to match vandetanib 100 mg and 300 mg Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) 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). Placebo to match vandetanib 100 mg and 300 mg Placebo to match ZD6474 (Vandetanib at the dose of 300 mg) 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). Vandetanib at the dose of 100 mg Fulvestrant 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) Vandetanib at the dose of 300 mg Fulvestrant 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) Placebo to match vandetanib 100 mg and 300 mg Fulvestrant 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).
- Primary Outcome Measures
Name Time Method Event Free Survival Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression. Success rate (patients without progression and still on treatment at 24 weeks
- Secondary Outcome Measures
Name Time Method Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR) Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression. Overall Survival Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent. Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes Continuous assessment of safety.
Trial Locations
- Locations (1)
Research Site
🇮🇹Varese, Italy