NKTR-102 in Metastatic Breast Cancer
Research type
Research Study
Full title
A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated with an Anthracycline, a Taxane, and Capecitabine
IRAS ID
215056
Contact name
Christopher Twelves
Contact email
Sponsor organisation
Nektar Therapeutics
Eudract number
2016-002453-38
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
The purpose of the study is to test if the study drug is safe and effective at treating patients with metastatic breast cancer where their cancer cells have spread to the brain (stable brain metastases).
About 350 people will participate in the study. Eligible patients will be randomly assigned receive treatment with either study drug (group A) or the treatment of physician’s choice (group B). For the treatment of physician’s choice (TPC), the patient will be offered one drug from a list of standard of care drugs available. This will be an approved and marketed drug that the physician would prescribe for the patient if they were not participating in the study.
Patients in group A will receive the study drug, via intravenous infusion, on day 1 of each cycle. Each cycle for group A patients is 3 weeks (21 days) long. Patients in group B will be given their TPC according to the prescribing guidelines at the hospital. Depending on which drug is chosen, one cycle in group B will be either 3 weeks (21 days) or 4 weeks (28 days) long.
A number of assessments and procedures will be performed during the study including physical examinations, quality of life questionnaires, blood sample assessments and CT/MRI scans to determine disease status. These assessments are performed as part of the evaluation to determine if the study drug is effective and safe.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0002
Date of REC Opinion
17 Jan 2017
REC opinion
Favourable Opinion