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

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ClinicalTrials.gov Identifier: NCT00752986

Recruitment Status : Terminated

First Posted : September 16, 2008

Results First Posted : October 6, 2014

Last Update Posted : December 5, 2016

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Genzyme, a Sanofi Company )

Study Description

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..

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: ZD6474 (Vandetanib at the dose of 100 mg) Drug: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) Drug: Fulvestrant Drug: ZD6474 (Vandetanib at the dose of 300 mg) Drug: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)	Phase 2

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	December 2008
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

Drug Information available for: Fulvestrant Vandetanib

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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)	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: 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: 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 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)	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
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).	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: 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

Outcome Measures

Primary Outcome Measures :

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. ]
Success rate (patients without progression and still on treatment at 24 weeks

Secondary Outcome Measures :

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. ]
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. ]
Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes [ Time Frame: Continuous assessment of safety. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752986

Locations

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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, Italy

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

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Study Director:	Clinical Sciences & Operations	Sanofi

More Information

Additional Information:

D4200L00009_Clinical_Report_Synopsis This link exits the ClinicalTrials.gov site

Publications:

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.

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Responsible Party:	Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:	NCT00752986
Other Study ID Numbers:	D4200L00009 EUDRACT 2008-000579-12
First Posted:	September 16, 2008 Key Record Dates
Results First Posted:	October 6, 2014
Last Update Posted:	December 5, 2016
Last Verified:	October 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):


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

Additional relevant MeSH terms:

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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents, Hormonal	Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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