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Fulvestrant +/- Vandetanib in Advanced Aromatase Inhibitor Resistant Breast Cancer

NCT02530411 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-08-21

No results posted yet for this study

Summary

A randomised double blind placebo controlled phase II study of fulvestrant with or without the addition of vandetanib as treatment for patients with metastatic breast cancer resistant to aromatase inhibitor therapy.

Conditions

  • Neoplasms

Interventions

DRUG

Fulvestrant

The pharmacology and mode of action studies established that fulvestrant is the first agent in a new class of anti-estrogens that down-regulate the estrogen receptor (ER), and can therefore be described as an ER down-regulator.

DRUG

Vandetanib

Vandetanib is a potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptor (VEGFR; also known as kinase insert domain containing receptor)-2, an endothelial cell receptor for vascular endothelial growth factor (VEGF), and also possesses activity against epidermal growth factor receptor (EGFR) and Rearranged during Transfection (RET) tyrosine kinases.

Sponsors & Collaborators

Principal Investigators

  • Mark Beresford, MD MRCP FRCR · Royal United Hospital NHS Trust, Bath, UK

  • Robert Jones, MD PhD MCRCP · Velindre NHS Trust, Cardiff, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-12-31
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02530411 on ClinicalTrials.gov