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8110 Gatehouse Road, Falls Church, VA 22042

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)

General Information

Age Group

Adult

Status

Recruiting

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:
    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
  • 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

For more information, go to https://clinicaltrials.gov/ct2/show/NCT03778931?term=NCT03778931&rank=1