A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
Start Date
6/15/2026
Completion Date
2/28/2029
Summary
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.
Detailed Description
This global, multicenter, Phase IIIb, single-arm study will evaluate the efficacy, safety, and tolerability of camizestrant combined with ribociclib in patients with ER+ HER2- advanced breast cancer who have not previously received systemic therapy for advanced disease. Approximately 150 participants will be enrolled, and all enrolled participants will receive standard daily oral doses of camizestrant 75 mg and ribociclib 600 mg until treatment discontinuation.
Eligibility Criteria
Age Range: 18 years to 130 years
Interventions
Camizestrant
Ribociclib
Conditions
Locations
Research Site
Duarte, California 91010
United States
Research Site
Palo Alto, California 94304
United States
Research Site
Marietta, Georgia 30060
United States
Research Site
Evanston, Illinois 60201
United States
Research Site
Edgewood, Kentucky 41017
United States
Research Site
Louisville, Kentucky 40202
United States
Research Site
Reno, Nevada 89502
United States
Research Site
Sioux Falls, South Dakota 57105
United States
Research Site
Nashville, Tennessee 37204
United States
Research Site
Fort Worth, Texas 76104
United States
Research Site
Kingwood, Texas 77339
United States
Research Site
Midlothian, Virginia 23114
United States
Research Site
Angers, 49933
France
Research Site
Bayonne, 64109
France
Research Site
Bobigny, 93000
France
Research Site
Caen, 14000
France
Research Site
Chambray-lès-Tours, 37170
France
Research Site
Grenoble, 38043
France
Research Site
Montpellier, 34070
France
Research Site
Nancy, 54100
France
Research Site
Nîmes, 30029
France
Research Site
Paris, 75014
France
Research Site
Pierre-Bénite, 69310
France
Research Site
Valenciennes, 59300
France
Research Site
Vandœuvre-lès-Nancy, 54519
France
Research Site
Villejuif, 94805
France
Research Site
Berlin, 13125
Germany
Research Site
Düsseldorf, 40235
Germany
Research Site
Freiburg im Breisgau, 79110
Germany
Research Site
Mönchengladbach, 41061
Germany
Research Site
München, 81675
Germany
Research Site
Paderborn, 33098
Germany
Research Site
Trier, 54290
Germany
Research Site
Velbert, 42551
Germany
Research Site
Aviano, 33081
Italy
Research Site
Bergamo, 24127
Italy
Research Site
Genova, 16132
Italy
Research Site
Milan, 20127
Italy
Research Site
Naples, 80131
Italy
Research Site
Gdansk, 80-952
Poland
Research Site
Konin, 62-500
Poland
Research Site
Krakow, 30-688
Poland
Research Site
Lodz, 90-302
Poland
Research Site
Lublin, 20-090
Poland
Research Site
Poznan, 61-485
Poland
Research Site
Przemyśl, 37-700
Poland
Research Site
Wroclaw, 53-413
Poland
Research Site
Cheonan-si, 31151
South Korea
Research Site
Daegu, 42415
South Korea
Research Site
Goyang-si, 10408
South Korea
Research Site
Hwasun-eup, 58128
South Korea
Research Site
Incheon, 405-760
South Korea
Research Site
Seongbuk-Gu, 02841
South Korea
Research Site
Seongnam-si, 13520
South Korea
Research Site
Seongnam-si, 13620
South Korea
Research Site
Seoul, 03080
South Korea
Research Site
Seoul, 06273
South Korea
Research Site
Seoul, 06351
South Korea
Research Site
Seoul, 06591
South Korea
Research Site
Seoul, 07985
South Korea
Research Site
Seoul, 3722
South Korea
Research Site
Songpa-gu, 05505
South Korea
Research Site
Suwon, 16499
South Korea
Research Site
Badajoz, 06080
Spain
Research Site
Badalona, 08916
Spain
Research Site
Barcelona, 08041
Spain
Research Site
Burgos, 9006
Spain
Research Site
Donostia / San Sebastian, 20014
Spain
Research Site
Huelva, 21005
Spain
Research Site
Jaén, 23007
Spain
Research Site
Las Palmas de Gran Canaria, 35016
Spain
Research Site
Majadahonda, 28222
Spain
Research Site
Málaga, 29010
Spain
Research Site
Murcia, 30008
Spain
Research Site
Oviedo, 33011
Spain
Research Site
Palma de Mallorca, 07198
Spain
Research Site
Pontevedra, 36312
Spain
Research Site
Pozuelo de Alarcón, 28223
Spain
Research Site
Santander, 39008
Spain
Research Site
Toledo, 45007
Spain
Research Site
Zaragoza, 50009
Spain
Research Site
Basel, 4031
Switzerland
Research Site
Liestal, CH-4410
Switzerland
Research Site
Rennaz, 1847
Switzerland