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Breast
General Information
Study Name:
Elacestrant Monotherapy for the Treatment of ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)
Age Group:
Adult
Protocol Number:
NCT03778931
Background Information:
This study will be comparing the safety and effectiveness of elacestrant to a selection of medications that are already approved and used to treat ER+/HER2- Advanced Breast Cancer.
Offered at:
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Eligibility Information
Participants must be 18 years of age or older
Participants have histologically or cytologically 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
Participants must be appropriate candidates for endocrine monotherapy
Female participants must be postmenopausal
Male participants must have suppression of testicular hormone production through chemical ablation with an approved GnRH agonist, starting at least six weeks prior to study entry and continuing without interruption for the duration of protocol treatment
Participants with ER+/HER2- tumor status
Additional eligibility in protocol
Ineligibility Information
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 metastatic visceral disease, defined as extensive hepatic involvement, untreated or progressive CNS metastases, or symptomatic pulmonary lymphangitic spread. Subjects with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised. Subjects with previously treated CNS metastases are eligible provided that all known lesions were previously treated, they have completed radiotherapy at least 28 days prior to first dose of study drug, are clinically stable, and require no steroid medication.
Additional exclusions in protocol
Contact Information
Contact Name:
Breast Cancer Research Team
Contact Phone:
571-472-0629
Contact Email:
breastcancerresearch@inova.org
For more information, go to
https://clinicaltrials.gov/ct2/show/NCT03778931?term=NCT03778931&rank=1