Clinical trial NCT00752986: ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 39
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Event Free Survival
timeFrame: 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.
Secondary outcomes:
measure: Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)
timeFrame: 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.
measure: Overall Survival
timeFrame: Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.
measure: Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes
timeFrame: Continuous assessment of safety.
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Research Site
city: Benevento
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monserrato
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Prato
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Trento
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Ciardiello F, Caputo R, Damiano V, Caputo R, Troiani T, Vitagliano D, Carlomagno F, Veneziani BM, Fontanini G, Bianco AR, Tortora G. Antitumor effects of ZD6474, a small molecule vascular endothelial growth factor receptor tyrosine kinase inhibitor, with additional activity against epidermal growth factor receptor tyrosine kinase. Clin Cancer Res. 2003 Apr;9(4):1546-56.