The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with and without an ESR1 mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Elacestrant will be administered orally once daily at a dose of 345 mg daily.
Initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.
The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.
NYU Langone Health
New York, New York, United States
RECRUITINGMedian progression-free survival
Progression-free survival will be measured as the time from the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first.
Time frame: From the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first (up to 2 years)
Objective response rate (ORR)
Overall response rate, defined as the percentage of patients who achieve a Best Overall Response (BOR) of confirmed partial response (PR) or complete response (CR).
Time frame: End of treatment (up to 2 years)
Duration of response (DoR)
Time frame: Time from the date of first documented CR/PR until the first radiological documentation of disease progression or death, whichever comes first (up to 2 years)
Change in 36-Item Short Form (SF-36) Health Survey
36-Item Short Form (SF-36) Health Survey (Version 2) The physical component summary (PCS) score, derived from the 36-Item Short Form (SF-36) Health Survey (Version 2). The range of the SF-36 PCS is between 0 and 100, where higher scores represent better physical functioning.
Time frame: Baseline, End of treatment (up to 2 years)
Overall survival (OS)
Overall survival is defined as the time from the date of the first dose to the date of death from any cause.
Time frame: From the date of the first dose to the date of death from any cause (up to 2 years)
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