Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
Eligible patients will be randomised to receive 400 mg/day oral elacestrant OR the investigator's choice of standard of care therapy (either fulvestrant, anastrozole, letrozole, or exemestane).
Conditions
This trial is treating people with breast cancer
Eligibility
Inclusion
- 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 with Guardant360CDx® before subject is randomized.
Exclusion
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Radius Pharmaceuticals, Inc.
Scientific 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
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