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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
ZD6474 (Vandetanib at the dose of 100 mg)
Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
Fulvestrant
ZD6474 (Vandetanib at the dose of 300 mg)
Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vandetanib at the dose of 100 mg

Vandetanib at the dose of 300 mg

Placebo to match vandetanib 100 mg and 300 mg

Arm Description

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)

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 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).

Outcomes

Primary Outcome Measures

Event Free Survival
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)
Overall Survival
Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes

Full Information

First Posted
September 15, 2008
Last Updated
October 11, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00752986
Brief Title
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. 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..
Detailed Description
end-point Efficacy: event-free survival (EFS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vandetanib at the dose of 100 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Vandetanib at the dose of 300 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo to match vandetanib 100 mg and 300 mg
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
ZD6474 (Vandetanib at the dose of 100 mg)
Other Intervention Name(s)
Zactima
Intervention Description
100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Intervention Type
Drug
Intervention Name(s)
Placebo to match ZD6474 (Vandetanib at the dose of 100 mg)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ZD6474 (Vandetanib at the dose of 300 mg)
Other Intervention Name(s)
Zactima
Intervention Description
300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Intervention Description
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
Primary Outcome Measure Information:
Title
Event Free Survival
Description
Success rate (patients without progression and still on treatment at 24 weeks
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes
Time Frame
Continuous assessment of safety.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Avellino
Country
Italy
Facility Name
Research Site
City
Benevento
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Monserrato
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Prato
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Trento
Country
Italy
Facility Name
Research Site
City
Varese
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
12684431
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.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1442&filename=D4200L00009_CSR_Synopsis.pdf
Description
D4200L00009_Clinical_Report_Synopsis

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

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