Phase 3 Trial of Balixafortide in Patients with HER2 -ve Breast Cancer
Research type
Research Study
Full title
An International, Phase 3, Multicenter, Randomized, Open Label Trial Comparing Balixafortide In combination with Eribulin versus Eribulin alone in Patients with HER2 negative, Locally Recurrent or Metastatic Breast Cancer.
IRAS ID
260081
Contact name
Peter Schmid
Contact email
Sponsor organisation
Polyphor Ltd.
Eudract number
2018-004211-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
118.448, IND Number
Duration of Study in the UK
2 years, 7 months, 5 days
Research summary
Research Summary - Breast cancer is the most common cancer that affects women worldwide. Unfortunately, following initial treatment, some patients subsequently relapse with breast cancer spread to other organs (metastasis). The purpose of this study, is to determine if balixafortide combined with eribulin is more effective for treating advanced metastatic breast cancer compared with eribulin given alone. The combination of balixafortide and eribulin is intended to improve disease control in patients with metastatic breast cancer.
The study starts with a 21 day screening period where eligible patients will be randomized and entered into an open label arm of either balixafortide + eribulin or eribulin on its own. Patients will have a 50/50 chance of receiving either study arm.
Patients will receive 21 day cycles of treatment that will repeat until the disease has progressed. All patients will receive eribulin on days 2 and 9 of each cycle, patients who are on balixafortide + eribulin will also receive balixafortide on days 1-3 and days 8-10 of each cycle.
Patients will be evaluated on the drug response and disease progression via CT and MRI scans every 6 weeks during the first year and then every 12 weeks thereafter.
Patients will continue treatment until the investigator documents any unacceptable results, death or patient withdrawal. Patients who withdraw will continue a follow-up phase
At the end of treatment, patients will have a full physical examination including ECG and vital signs.Patients will undergo a 30 day safety follow-up.
Long-term survival follow-up will occur every 8 weeks while the patient is receiving study medication including a CT and/or MRI scan to assess the tumour. Thereafter the study doctor will contact the patient every 6 months to assess the long-term survival status.
This study is sponsored by Polyphor Ltd. Approximately 384 patients will participate in this study worldwide, with 15 patients in the UK.
Summary of Results
No lay study results summary will be created for this trial. But results will be posted on both EudraCT and CT.gov.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0235
Date of REC Opinion
19 Aug 2019
REC opinion
Further Information Favourable Opinion