Spots Global Cancer Trial Database for Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
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Trial Identification
Brief Title: Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Official Title: A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer
Study ID: NCT05563220
Study Description
Brief Summary: This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.
Detailed Description: This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of patients experiencing a DLT of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib, that is, ≤1 patient experiencing a DLT out of 6 DLT evaluable patients. For each combination, this phase will have between 1 and 3 cohorts of 6 DLT-evaluable patients each. The total number of DLT-evaluable patients in all the combinations will vary between 24 and 72. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer. The treatment arms will be: * Arm A: 50 patients: elacestrant with alpelisib; * Arm B: 50 patients: elacestrant with everolimus; * Arm C: 60 patients (30 patients in each combination): elacestrant with either abemaciclib or ribociclib; * Arm D: 90 patients (30 patients in each combination): elacestrant with either palbociclib, abemaciclib, or ribociclib * Arm E: 60 patients: elacestrant with capivasertib Phase 1b will have a total of 90 patients, while Phase 2 will have 310 patients for all treatment arm combinations.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dothan Hematology and Oncology, Dothan, Alabama, United States
Mayo Clinic - Arizona, Phoenix, Arizona, United States
Highlands Oncology Group, Springdale, Arkansas, United States
OPN Healthcare (Arcadia Location), Arcadia, California, United States
Glendale Adventist, Glendale, California, United States
OPN Healthcare (Los Alamitos Location), Los Alamitos, California, United States
Cedars Sinai, Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
TOI Clinical Research, Whittier, California, United States
Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States
Yale School Of Medicine - Smilow Cancer Hospital - Breast Center, New Haven, Connecticut, United States
George Washington Cancer Center, Washington, District of Columbia, United States
Advent Health (Florida Hospital) - Altamonte Springs, Altamonte Springs, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Ocala Oncology, Ocala, Florida, United States
Northwestern Feinberg Scholl of Medicine Prentice Women's Hospital, Chicago, Illinois, United States
MD Alliance for Multispecialty Research, LLC, Merriam, Kansas, United States
New England Cancer Specialists, Scarborough, Maine, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Minnesota Oncology Hematology, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States
Astera Cancer Care, East Brunswick, New Jersey, United States
Summit Medical Group, Florham Park, New Jersey, United States
NYU Langone Health, New York, New York, United States
New York Cancer and Blood Specialists, Port Jefferson Station, New York, United States
W&IH of RI Breast Health Center of Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Sarah Cannon Research Institute / Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center Texas, Houston, Texas, United States
UT Health San Antonio, San Antonio, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Cancer Care Northwest, Spokane Valley, Washington, United States
Northwest Medical Specialties (Nwms) - Puyallup - Medical Oncology (Rainier Hematology-Oncology)/Exigent Research Network; LLC, Tacoma, Washington, United States
University of WI - Carbone Cancer Center (Phase II only), Madison, Wisconsin, United States
Contact Details
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