Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE)
NYU Langone Health
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Female patients aged 18 years or older. 2. Should be able to provide the informed consent. 3. Histologically confirmed diagnosis of triple-positive breast cancer (ER+, PR+, HER2+). In the study, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with PR\>1%. Patients may be considered to be enrolled on study with prior approval of study PI if ER \>10% and without PGR positivity HER2 status will be considered positive with the score of 3+ with immunohistochemistry staining or 2+ by immunohistochemis…
Interventions
- DrugElacestrant
Elacestrant will be administered orally once daily at a dose of 345 mg daily.
- DrugTrastuzumab
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.
- DrugPertuzumab
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.
Location
- NYU Langone HealthNew York, New York