PF-03084014 IN PATIENTS WITH ADVANCED TRIPLE-NEGATIVE BREAST CANCER
Research type
Research Study
Full title
PHASE 2 STUDY OF SINGLE-AGENT PF 03084014 IN PATIENTS WITH ADVANCED TRIPLE-NEGATIVE BREAST CANCER WITH OR WITHOUT GENOMIC ALTERATIONS IN NOTCH RECEPTORS
IRAS ID
161229
Contact name
Nicholas Turner
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2014-002286-30
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
The A8641020 trial has been designed to evaluate the safety and effectiveness of an experimental drug called PF 03084014 given by mouth to women aged 18 and over who have advanced triple-negative breast cancer. This type of breast cancer comprises approximately 15% of all breast cancer cases.
The study will also look at how this drug acts within the body and the way the body affects the drug. This is assessed by collecting blood samples from the participants.
The drug has previously been tested in healthy adult volunteers.
Study participants will visit the hospital where the research is being conducted on approximately 9 occasions. They will have their general health monitored, blood samples taken, bone scans, CT or MRI scans and tumour biopsies whilst in the study.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/2126
Date of REC Opinion
12 Dec 2014
REC opinion
Favourable Opinion