CLEE011A2404. Ribociclib and Letrozole in HR+, HER- breast cancer
Research type
Research Study
Full title
COMPLEEMENT-1: An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and postmenopausal women with hormone receptorpositive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease
IRAS ID
214371
Contact name
Alistair Ring
Contact email
Eudract number
2016-003467-19
Duration of Study in the UK
3 years, 10 months, 1 days
Research summary
This study (CLEE011A2404) is an open-label, single arm, Phase IIIb study to evaluate the overall safety, tolerability and efficacy of ribociclib (LEE011) in combination with letrozole. The patients treated will be men and postmenopausal women with Hormone receptor positive (HR+), HER2 negative (HER2-) advanced breast cancer who have not had previous hormone treatment for their advanced disease. Approximately 3,000 patients will be enrolled in this study globally.
Recent results from the MONALEESA-2 (NCT01958021) Phase III study show that the combination of ribociclib and letrozole slows down the growth of HR+,HER2- advanced breast cancers more than the standard treatment of letrozole alone. These results will be presented at the European Society of Medical Oncology (ESMO) 7th-11th October 2016.
The purpose of this study (CLEE011A2404) is to collect additional safety and efficacy data for the combination of ribociclib and letrozole in a broad population of patients. While MONALEESA-2 did not include patients who had received previous chemotherapy or male patients, CLEE011A2404 will include these patients as well as the groups eligible for MONALEESA-2.
Study treatment will be provided until disease progression, physician’s decision, or until the end of study, whichever event occurs first. There will be a 28 day screening phase, followed by a study treatment phase, during which time patients will attend the hospital monthly, then an end of treatment and safety follow up visit.
This study is sponsored by Novartis, a pharmaceutical company.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0463
Date of REC Opinion
10 Nov 2016
REC opinion
Favourable Opinion