Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

Part of paid clinical trials in Fullerton, California.

Sponsor
Stemline Therapeutics, Inc.
Study ID
NCT05386108
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Brain Diseases
  • Brain Neoplasms
  • Breast Diseases
  • Breast Neoplasms
  • Central Nervous System Diseases
  • Central Nervous System Neoplasms
  • Neoplasms
  • Neoplasms by Site

Eligibility Criteria

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

Interventions

  • Elacestrant — DRUG
    300 mg, 400 mg
  • Abemaciclib — DRUG
    100 mg, 150 mg

Study Details

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.

Key Dates

Start date
Aug 31, 2022
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
73 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b Cohort 1
    Elacestrant 300 milligrams (mg) once daily (QD) + abemaciclib 100 mg twice daily (BID)
  • Experimental: Phase 1b Cohort 2
    Elacestrant 400 mg QD + abemaciclib 100 mg BID
  • Experimental: Phase 1b Cohort 3
    Elacestrant 400 mg QD + abemaciclib 150 mg BID
  • Experimental: Phase 2
    Elacestrant in combination with abemaciclib at the RP2D determined in Phase 1b

Primary Outcome Measure

Phase 1b: RP2D [ Time Frame: Cycle 1 (28 days) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Providence Medical FoundationFullertonCalifornia92835
Monica Lee (PRINCIPAL_INVESTIGATOR)
California Research InstituteLos AngelesCalifornia90027
Ghassan Al-Jazavrly (PRINCIPAL_INVESTIGATOR)
Carle Cancer CenterUrbanaIllinois61801
Kendrith Rowland (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Nancy Lin (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202
Haythem Ali (PRINCIPAL_INVESTIGATOR)
Miami Valley Hospital SouthCentervilleOhio45459
Jhansi Koduri (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239-
SCRI Oncology PartnersNashvilleTennessee37203
Denise Yardley (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Nuhad Ibrahim (PRINCIPAL_INVESTIGATOR)
UT Health San Antonio University of TexasSan AntonioTexas78229-
Virginia Cancer InstituteNorfolkVirginia00115
Michael Danso (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fullerton, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Providence Medical Foundation· Fullerton, CACalifornia Research Institute· Los Angeles, CACarle Cancer Center· Urbana, ILDana-Farber Cancer Institute· Boston, MAHenry Ford Hospital· Detroit, MIMiami Valley Hospital South· Centerville, OH

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