Clinical Trials /

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

NCT03778931

Description:

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) .

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
  • Official Title: Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

Clinical Trial IDs

  • ORG STUDY ID: RAD1901-308
  • NCT ID: NCT03778931

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
ElacestrantRAD1901Elacestrant
Standard of CareFaslodex, Arimidex, Femara, AromasinStandard of Care (SoC)

Purpose

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) .

Detailed Description

      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 Arms

NameTypeDescriptionInterventions
ElacestrantExperimentalSubjects in Arm 1 will receive elacestrant
  • Elacestrant
Standard of Care (SoC)Active ComparatorSubjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
  • Standard of Care

Eligibility Criteria

        Critical Inclusion Criteria:

          1. 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.

          2. Subjects must be appropriate candidates for endocrine monotherapy

          3. Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease

          4. 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).

          5. Subjects must have ER+/HER2-tumor status

          6. 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.

          7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination
             with either fulvestrant or an aromatase inhibitor (AI).

          8. Subjects may have received no more than one line of chemotherapy in the
             advanced/metastatic setting.

          9. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing
             before subject is randomized.

        Critical Exclusion Criteria:

          1. Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496,
             bazedoxifene, or other investigational SERD or investigational ER antagonist.

          2. Prior anticancer or investigational drug treatment within the following windows:

               1. Fulvestrant treatment < 28 days before first dose of study drug

               2. Any endocrine therapy < 14 days before first dose of study drug (with the
                  exception of GnRH agonist therapy in male subjects)

               3. Chemotherapy < 21 days before first dose of study drug

               4. 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

          3. Presence of symptomatic visceral disease as defined in protocol.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) in the ESR1-mut subjects
Time Frame:From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Safety Issue:
Description:Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects

Secondary Outcome Measures

Measure:Objective Survival (OS) in ESR1-mut subjects
Time Frame:From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause
Measure:OS in all (ESR1-mut and ESR1-WT) subjects
Time Frame:From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:OS in all (ESR1-mut and ESR1-WT) subjects

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Radius Pharmaceuticals, Inc.

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