The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
Determine the best sequences.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
administration of the TDM1 by IV perfusion
local RT
Institut regional du Cancer - Val d Aurelle
Montpellier, France
optimal sequences of combined treatment
To determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
Time frame: 3 months
objective response
Objective responses (complete and partial response) by MRI according to the RECIST criteria (v1.1) and volumetric assessment
Time frame: 1 year
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