After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms: Arm A. Eribulin Arm B. Paclitaxel Blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.
This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
on days 1 and 8 q21d
on days 1, 8, and 15 q21d
Department of Gynecology, Tübingen University Hospital
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGDepartment of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, Germany
RECRUITINGImmune responsivity (IR)
defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
Time frame: 12 weeks after therapy start
Overall response after three months
Overall response
Time frame: three months after therapy start
Progression free survival
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
Overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Toxicity and safety of eribulin and paclitaxel
Toxicity and safety of eribulin and paclitaxel
Time frame: Therapy start until 30 days post last dose
EORTC QLQC30
Quality of life assessed via EORTC QLQC30
Time frame: Therapy start until therapy end after 4 cycles up to 12 weeks
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