A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE)

NCT03701334 PHASE3 ACTIVE_NOT_RECRUITING

A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	PHASE3
Status	ACTIVE_NOT_RECRUITING
Enrolment	5101
Start date	Fri Dec 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed May 29 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Early Breast Cancer

Interventions

• Ribociclib
• Endocrine Therapy (ET)

Countries

Belgium, Romania, United States, Italy, Ireland, Taiwan, Australia, Canada, Argentina, Hungary, Poland, South Korea, Brazil, Spain, Austria, France, Germany, United Kingdom, Russia, China