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

Breast Cancer Clinical Trial

— ZACFAST  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00752986
• Other study ID #: D4200L00009
• Secondary ID: EUDRACT 2008-000
• Status: Terminated
• Phase: Phase 2
• First received: September 15, 2008
• Last updated: October 6, 2014
• Start date: December 2008
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: ITALY: Comitato Etico Dell´IRCCS Istituto Nazionale Per Lo Studio E LA Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli
• Study type: Interventional

Clinical Trial 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..

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• 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
• 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.
• 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.
• 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

Locations

Country	Name	City	State
Italy	Research Site	Avellino
Italy	Research Site	Benevento
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Monserrato
Italy	Research Site	Napoli
Italy	Research Site	Palermo
Italy	Research Site	Prato
Italy	Research Site	Roma
Italy	Research Site	Trento
Italy	Research Site	Varese

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival	Success rate (patients without progression and still on treatment at 24 weeks	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes		Continuous assessment of safety.	Yes

External Links

•   D4200L00009_Clinical_Report_Synopsis