Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03786094
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03786094
Study Brief:
Protocol Section:
NCT03786094