Status:
TERMINATED
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Spexis AG
Conditions:
Metastatic Breast Cancer
Locally Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 er...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2021
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT03786094
Start Date
May 30 2019
End Date
October 19 2021
Last Update
November 1 2023
Active Locations (88)
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1
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93720
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UCSF Mount Zion Cancer Center
San Francisco, California, United States, 94115
4
Stanford Cancer Center South Bay
San Jose, California, United States, 95124