Metastatic Breast Cancer
Conditions
Keywords
Overall survival, Progression free survival
Brief summary
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated
Interventions
DRUGPOL6326
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin
Sponsors
Polyphor Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer | 6 months | Incidence and severity of adverse events and serious adverse events of the combination of POL6326 and eribulin when compared to the adverse event profile of eribulin alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer | 12-24 months | Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin |
Countries
Spain, United States
Outcome results
None listed