FURVA, Version 1.0
Research type
Research Study
Full title
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.
IRAS ID
153819
Contact name
Robert Jones
Contact email
Sponsor organisation
Velindre NHS Trust
Eudract number
2014-001208-23
Duration of Study in the UK
3 years, 6 months, 2 days
Research summary
In advanced breast cancer that has spread around the body, hormone therapy is an effective treatment, and avoids the toxicity and inconvenience of chemotherapy. But eventually the cancer is likely to become resistant to the hormone therapy and in this situation alternative hormone drugs can be used, but the response rates are modest.
A signalling pathway called RET has been shown to be more active in cancer cells that have become resistant to hormone therapy. Vandetanib is an oral drug that inhibits the RET signalling in cells and has been shown in laboratory studies to prevent the growth of breast cancer cells which have become resistant to hormone therapy. We therefore believe that giving vandetanib in combination with hormone therapy may help prevent resistance to treatment in patients with breast cancer. In this trial we will combine vandetanib with fulvestrant, another hormone therapy which is sometimes used alone in patients who have developed resistance to other hormone treatments. Thus, patients entering the trial will have a known drug with proven efficacy and may also receive the experimental drug which could enhance activity.
To properly determine if vandetanib works as we believe, this study will compare the activity of vandetanib in combination with fulvestrant, versus fulvestrant with a placebo, in a population of patients where the treatment with fulvestrant alone is thought appropriate. It plans to recruit a total of 160 patients (half will receive vandetanib and half placebo).
The main outcome measure will be the time until the disease progresses, but the study will also look closely at the side effects of the drugs and also correlation of the effect with laboratory studies on the RET pathways in individual cancers (this will be performed on previously stored tumour samples and will not require patients to have additional biopsies).
REC name
Wales REC 3
REC reference
14/WA/1219
Date of REC Opinion
18 Dec 2014
REC opinion
Further Information Favourable Opinion