Education and Training
Pivotal Study in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Eribulin
- drug: Balixafortide
Eligibility
Key Inclusion Criteria:
- 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 Criteria:
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ann Moffat
amoffat@stanford.edu
Not Recruiting
Stanford Cancer Center South Bay
2589 Samaritan Drive
San Jose,
CA
95124
Ann Moffat
669-233-2816
Not Recruiting