ALERT
Research type
Research Study
Full title
ALERT: A phase II study of alternating eribulin and hormonal therapy in pre-treated ER+ve breast cancer
IRAS ID
165317
Contact name
Gary Roper
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Eudract number
2014-004112-11
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
This is a single centre, single arm, phase II investigator led and academically sponsored study. 12 patients aged 18 or over with histologically confirmed oestrogen receptor positive locally advanced or metastatic breast cancer, who have received at least one hormonal therapy regime and at least one chemotherapy regime for advance disease, will be enrolled.
Treatment will alternate between eribulin and AIs, to see if relapse during AI therapy can be delayed, or if we can extend how long patients stay on eribulin treatment. The study will also look at various biomarkers; these are distinctive features found in the body, which can be used to measure or predict the progress of the cancer or the effects of treatment. This will help in our understanding of who may benefit from receiving the study drugs in the future.
The trial will be funded by Eisai Ltd and Action Against Cancer, and patients will be recruited from Imperial College Healthcare NHS Trust. Patients will undergo a 28 day screening period. Once confirmed as eligible, patients remain on treatment for up to 9 months or until disease progression, unacceptable toxicities or patient choice, whichever is sooner. Patients will receive 3 cycles of eribulin, followed by 9 weeks of treatment with an AI, followed by a further 3 cycles of eribulin and 9 weeks of an AI. Eribulin will be given to patients in hospital on day 1 and day 8 of each 3 week cycle. AI treatment will be taken by the patients at home. During study treatment patients will be asked to attend hospital regularly to be reviewed by their doctor and undergo tests (some routine and some extra for the purpose of the study) to monitor their progress. Patients will attend a safety follow up visit 4 weeks after completing treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0571
Date of REC Opinion
20 May 2015
REC opinion
Further Information Favourable Opinion