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:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT01837095
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01837095
Study Brief:
Protocol Section:
NCT01837095