Spots Global Cancer Trial Database for Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
Official Title: An Open-Label, Phase 1b-2 Study of Elacestrant, in Combination With Onapristone in Patients With Estrogen Receptor-Positive, Progesterone Receptor-Positive, HER2-negative Advanced or Metastatic Breast Cancer (ELONA)
Study ID: NCT05618613
Conditions
Study Description
Brief Summary: This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
Detailed Description: This is a multicenter, phase 1b-2 trial. The phase 1b part of the trial is open label and aims to determine the recommended Phase 2 dose (RP2D) of onapristone and elacestrant when administered together. The Phase 2 part of the trial will evaluate the efficacy and safety of this combination in patients with ER+/PgR+/HER2- advanced/metastatic breast cancer after prior therapy with a CDK4/6 inhibitor.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Treatment Centers of America - Western Regional Medical Center, Phoenix, Arizona, United States
Cancer Treatment Centers of America - Midwestern Regional Center, Zion, Illinois, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Contact Details
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