ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
NCT ID: NCT00752986
Last Updated: 2016-12-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
39 participants
INTERVENTIONAL
2008-12-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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)
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
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.
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
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)
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 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).
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
FEMALE
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Research Site
Avellino, , Italy
Research Site
Benevento, , Italy
Research Site
Genova, , Italy
Research Site
Milan, , 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, , Italy
Countries
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References
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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.
Related Links
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D4200L00009\_Clinical\_Report\_Synopsis
Other Identifiers
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EUDRACT 2008-000579-12
Identifier Type: -
Identifier Source: secondary_id
D4200L00009
Identifier Type: -
Identifier Source: org_study_id