A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer
- Histologically confirmed invasive cancer of the breast.
- Presence of at least one measurable lesion per RECIST 1.1 criteria
- Stage IV disease by AJCC criteria (7th edition).
- HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio < 2.0)
- Must have had treatment with at least 2 but no more than 3 previous regimens in the
metastatic setting. Previous treatment must have included an anthracycline and taxane
in either the adjuvant or metastatic setting.
- At least 21 days from the completion of any previous cytotoxic chemotherapy or
biological therapy at time of initiation of POL6326.
- ECOG performance status < 2
- Previously received eribulin.
- Peripheral neuropathy > Grade 2.
- Receipt of any other investigational agent within the 28 days prior to Day 1.
- Receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim
within 14 days prior to Day 1.
- Radiation therapy within the 14 days prior to Day 1.
- Severe concurrent illness or psychiatric illness/social situation that would limit
compliance with study requirements.
- History of other malignancy ≤ 5 years previous with the exception of basal cell or
squamous cell carcinoma of the skin which were treated with local resection only or
carcinoma in situ of the cervix.
- Pregnant or breastfeeding.
- Known HIV positivity on combination antiretroviral therapy; these patients are at
increased risk of lethal infections when treated with marrow-suppressive therapy