A Randomised, 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 Breast Cancer Patients
N/A
N/A
Both
Breast Cancer
Trial Information
A Randomised, 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 Breast Cancer Patients
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Event Free Survival
Outcome 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.
Safety Issue:
No
Principal Investigator
Francesco Perrone, MD
Investigator Role:
Study Chair
Investigator Affiliation:
IRCCS ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI FONDAZIONE GIOVANNI PASCALE DI NAPOLI
Authority:
ITALY: Comitato Etico Dell´IRCCS Istituto Nazionale Per Lo Studio E LA Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli
Study ID:
D4200L00009
NCT ID:
NCT00752986
Start Date:
December 2008
Completion Date:
April 2013
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms
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