CLEE011O12301C (TRIO033) - NATALEE
Research type
Research Study
Full title
A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).
IRAS ID
255897
Contact name
Eleni Karapanagiotou
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-002998-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
117796, US IND number
Duration of Study in the UK
7 years, 2 months, 4 days
Research summary
The aim of this randomized phase 3 trial is to find out if the study drug ribociclib given with standard endocrine therapy is safe and more effective than standard endocrine therapy given alone for patients: diagnosed with early breast cancer and who had a tumor removed which is positive for hormone receptors and negative for HER2.
This study is designed to demonstrate if we can further reduce the risk that breast cancer comes back after surgery by adding an investigational drug called ribociclib, to one of the usual combination of drugs (endocrine therapy) that are used to treat this type of breast cancer. And also, by exploring how ribociclib behaves in the body, can we better understand the therapeutic use of ribociclib in early breast cancer, and can we identify patients likely or unlikely to respond to this treatment.
This is a multicenter study where about 4000 subjects will join in for a period of 5 to 7 years. Patients will need to attend hospital/clinical visits and undergo a number study procedures/tests. The study contains a Treatment part lasting 60 months (5 years/ 30 visits), followed by a Follow-up part (duration of Follow-up will be of about 2 years/ visit or call approximately every 6 months).
There are two treatment groups in the study: Group A (patients will take Endocrine Therapy alone) and Group B (patients will take ribociclib + endocrine therapy). Patients will be assigned randomly to one of the two groups at time of enrollment.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0011
Date of REC Opinion
11 Feb 2019
REC opinion
Further Information Favourable Opinion