Monaleesa 3 CLEE011F2301 ribiciclib/placebo + fulvestrant
Research type
Research Study
Full title
MONALEESA-3: A randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received no or only one line of prior endocrine treatment.
IRAS ID
181602
Contact name
Thierry Paquet-Luzy
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2015-000617-43
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 8 days
Research summary
Treatment of hormone receptor (HR) positive, HER2-negative breast cancer still represents an unmet medical need as a significant number of patients are expected to have, or to develop, resistance to endocrine therapies that have been given in the adjuvant or first line metastatic setting. CDK4/6 pathway alterations appear to play a key role in the development of this resistance. The rationale for assessing the efficacy of ribociclib, a CDK4/6 inhibitor, in combination with the hormonal agent fulvestrant, in a randomized Phase III study is therefore based upon the role of the CDK4/6 pathway in HR+ breast cancer and the potential synergy when combined with hormonal agents such as fulvestrant.
This is a randomized, phase III, double-blind, global trial comparing the combination of fulvestrant + ribociclib to fulvestrant + placebo in postmenopausal women with HR+, HER2-negative advanced breast cancer. The study will consist of a 21-day screening phase, of a treatment phase, and of a post-treatment phase which includes safety, efficacy, and survival follow up.
Patients will be randomly assigned to either fulvestrant+ribociclib or fulvestrant+placebo in a 2:1 ratio. Randomization will be stratified by the following factors: Lung or liver metastases (yes versus no) and previous endocrine therapy. The study will include 660 postmenopausal women with HR+ HER2-negative advanced breast cancer who received no or only one prior endocrine therapy.
This trial is sponsored by the pharmaceutical company named Novartis and because the safety and efficacy profile of Ribociclib has not yet been established in this group of patients, access to this investigational compound is available only through carefully controlled and monitored clinical trials such as this.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0302
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion