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Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+ / HER2- Advanced Breast Cancer

Trial Status: Closed to Accrual

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4 / 6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

Inclusion Criteria

  • Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.
  • Subjects must be appropriate candidates for endocrine monotherapy
  • Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease
  • Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).
  • Subjects must have ER+/HER2-tumor status
  • Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.
  • Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
  • Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.
  • Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing before subject is randomized.

Exclusion Criteria

  • Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist.
  • Prior anticancer or investigational drug treatment within the following windows:
  • Fulvestrant treatment < 28 days before first dose of study drug
  • Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects)
  • Chemotherapy < 21 days before first dose of study drug
  • Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor
  • Presence of symptomatic visceral disease as defined in protocol.

Arizona

Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
Los Angeles County-USC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Grace M Facio
Phone: 323-409-7027ext3511
Translational Research In Oncology - US Inc
Status: CLOSED_TO_ACCRUAL
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Sarah Rosales
Phone: 310-794-7686
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Grace M Facio
Phone: 323-409-7027ext3511
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: CLOSED_TO_ACCRUAL
Contact: Kristy Marie Massopust
Phone: 949-474-5733
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Washington Hospital Center
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Sherri Miller
Phone: 913-945-7658

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Newton
Newton-Wellesley Hospital
Status: CLOSED_TO_ACCRUAL

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Oregon

Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: APPROVED
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: CLOSED_TO_ACCRUAL
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

This is an international, multicenter, randomized, open-label, active-controlled,

event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the

SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men

with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that

harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene

(ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type

[ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two

prior lines of endocrine therapy (with documented progression), which must have included

prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI)

and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole,

letrozole, exemestane) is an appropriate treatment option.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Radius Pharmaceuticals, Inc.

  • Primary ID RAD1901-308
  • Secondary IDs NCI-2019-01456
  • Clinicaltrials.gov ID NCT03778931