ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial (ZACFAST)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00752986
First received: September 15, 2008
Last updated: October 6, 2014
Last verified: October 2014

September 15, 2008
October 6, 2014
December 2008
September 2013   (final data collection date for primary outcome measure)
Event Free Survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
Success rate (patients without progression and still on treatment at 24 weeks
Event Free Survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00752986 on ClinicalTrials.gov Archive Site
  • Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent. ] [ Designated as safety issue: No ]
  • Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes [ Time Frame: Continuous assessment of safety. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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..

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • 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
    Other Name: Zactima
  • 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.
    Other Name: Faslodex
  • 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.
    Other Name: Zactima
  • 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
  • Experimental: 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)
    Interventions:
    • Drug: ZD6474 (Vandetanib at the dose of 100 mg)
    • Drug: Fulvestrant
    • Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
  • Experimental: 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)
    Interventions:
    • Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
    • Drug: Fulvestrant
    • Drug: ZD6474 (Vandetanib at the dose of 300 mg)
  • Placebo Comparator: Placebo to match vandetanib 100 mg and 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).
    Interventions:
    • Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
    • Drug: Fulvestrant
    • Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00752986
D4200L00009, EUDRACT 2008-000579-12
No
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Francesco Perrone, MD IRCCS ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI
Principal Investigator: Andrea De Matteis, MD IRCCS ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI
Study Director: Peter Langmuir, MD AstraZeneca
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP