Home
Clinical Trials
Phase 3 Trial of Elacestrant ...

Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Last Updated: 2025-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2024-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

NCT02338349

Advanced ER+, HER2-Negative Breast Cancer

COMPLETED PHASE1

ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

NCT07198724

Metastatic Breast Cancer HER2 Low Breast Carcinoma HER2-negative Breast Cancer +2 more

NOT_YET_RECRUITING PHASE1/PHASE2

Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

NCT06201234

Hormone Receptor Positive HER-2 Negative Breast Cancer Advanced or Metastatic Breast Cancer BRCA1 Mutation +1 more

RECRUITING PHASE2

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

NCT06120283

Advanced Solid Tumor Advanced Breast Cancer Metastatic Breast Cancer +6 more

RECRUITING PHASE1

Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy

NCT00070031

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 participants with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut participants) or in all participants 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elacestrant

Participants in Arm 1 will receive elacestrant.

Group Type EXPERIMENTAL

Elacestrant

Intervention Type DRUG

400 mg/day once daily oral dosing

Standard of Care (SoC)

Participants in Arm 2 will receive investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane).

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DRUG

* Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle
* Anastrozole 1 mg/day on a continuous dosing schedule
* Letrozole: 2.5 mg/day on a continuous dosing schedule
* Exemestane: 25 mg/day on a continuous dosing schedule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elacestrant

400 mg/day once daily oral dosing

Intervention Type DRUG

Standard of Care

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RAD1901 ORSERDU Faslodex, Arimidex, Femara, Aromasin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants 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. Participants must be appropriate candidates for endocrine monotherapy
3. Participants must have measurable disease or bone only disease with evaluable lesions
4. Female or male participants age ≥ 18 years; female participants must be postmenopausal women, and male participants must not allow pregnancy with their sperm (abstain, do not donate sperm, et cetera).
5. Participants must have ER+ and HER2- tumor status
6. Participants 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. Participants must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI) for advanced/metastatic breast cancer (mBC).
8. Participants may have received no more than one line of chemotherapy in the advanced/metastatic setting.

Exclusion Criteria

1. Prior treatment with elacestrant or other investigational selective estrogen receptor degrader (SERD) or ER antagonist (D-0502, GDC-0810, GDC-0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasofoxifene).
2. Prior anticancer or investigational drug treatment within the following windows:

1. Fulvestrant treatment \< 42 days before first dose of study drug
2. Any endocrine therapy \< 14 days before first dose of study drug
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 participants whose most recent therapy was an investigational agent should be discussed with the Sponsor
5. Bisphosphonates or RANKL inhibitors initiated or dose changed \< 3 months prior to first dose of study drug
3. Presence of symptomatic visceral disease as defined in protocol.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

St Bernard's Cancer Care

Jonesboro, Arkansas, United States

Site Status

St. Jude Heritage Healthcare

Fullerton, California, United States

Site Status

Adventist Health Glendale

Glendale, California, United States

Site Status