Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
- Conditions
- Metastatic Breast CancerLocally Recurrent Breast Cancer
- Interventions
- Registration Number
- NCT03786094
- Lead Sponsor
- Spexis AG
- Brief Summary
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 432
- Histologically confirmed Breast cancer
- Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer
- refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy
- At least 14 days from the completion of any previous cancer therapy
- Adequate organ function
- Life expectancy of 3 months or more
- Willing and able to comply with the protocol and able to understand and willing to sign an informed consent
Key
- Previously treated with eribulin
- Peripheral neuropathy Grade ≥3
- Receipt of prior CXCR4 therapy
- Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study
- Breast feeding or pregnant
- Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) ≥470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eribulin Eribulin - Balixafortide + Eribulin Eribulin - Balixafortide + Eribulin Balixafortide -
- Primary Outcome Measures
Name Time Method Progression Free Survival (2nd Line+ Population) Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met. To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.
PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).Progression Free Survival (3rd Line+ Population) Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met. To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.
PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
- Secondary Outcome Measures
Name Time Method Overall Survival (3rd Line+ Population) The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first). To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.
Trial Locations
- Locations (88)
California Cancer Associates for Research and Excellence
🇺🇸Fresno, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCSF Mount Zion Cancer Center
🇺🇸San Francisco, California, United States
Stanford Cancer Center South Bay
🇺🇸San Jose, California, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Florida Cancer Specialists SOUTH - SCRI - PPDS
🇺🇸Fort Myers, Florida, United States
Orlando Health
🇺🇸Orlando, Florida, United States
Florida Cancer Specialists NORTH - SCRI - PPDS
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists PAN - SCRI - PPDS
🇺🇸Tallahassee, Florida, United States
Tallahassee Memorial HealthCare
🇺🇸Tallahassee, Florida, United States
Scroll for more (78 remaining)California Cancer Associates for Research and Excellence🇺🇸Fresno, California, United States