Elacestrant in Advanced Triple Positive Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07612215
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • ER Positive, HER2 Positive Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elacestrant — DRUG
    Elacestrant will be administered orally once daily at a dose of 345 mg daily.
  • Trastuzumab — DRUG
    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.
  • Pertuzumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Estrogen Receptor 1 (ESR1) wild-type (WT)
    Trastuzumab and pertuzumab and Elacestrant will be administered until disease progression, unacceptable toxicity or as per PI's decision
  • Experimental: ESR1 Mutated
    Trastuzumab and pertuzumab and Elacestrant will be administered until disease progression, unacceptable toxicity or as per PI's decision

Primary Outcome Measure

Median progression-free survival [ 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY