Study CLEE011G2301 (EarLEE-1) in High Risk Early Breast Cancer
Research type
Research Study
Full title
A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer
IRAS ID
228354
Contact name
Peter Schmid
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2014-001795-53
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 23 days
Research summary
This study will investigate whether the study drug, Ribociclib, when added to standard adjuvant endocrine treatment (ET) helps to reduce the risk of reappearance of cancer in patients with hormone receptor-positive, HER2-negative high risk early breast cancer (EBC). It will also investigate whether the combination of Ribociclib with a standard ET is safe for EBC patients. 'Hormone receptor-positive' and 'HER-2 negative' basically mean that the type of breast cancer is sensitive to certain sex hormones, like oestrogen and progesterone, which can encourage the breast cancer tumour to grow. 'Adjuvant ET' basically means after surgery to remove the breast cancer (the primary treatment), ET is given to lower the risk of cancer returning. The study will include 3 different phases:
1. Screening phase: Where the patient will be assessed for their suitability to enter the study (28 day duration).
2. Treatment phase: Approx 2000 participants will be randomised (by chance) to receive either Ribociclib 600 mg or placebo (an inactive dummy drug) once daily on days 1 to 21 of a 28 day cycle in combination with standard adjuvant ET. Patients will receive Ribociclib/placebo + ET treatment for a maximum of 26 cycles (approx 24 months). ET may start up to 12 weeks before the date of randomisation. ET includes orally administered Tamoxifen, Letrozole, Anastrozole, or Exemestane (men will take tamoxifen only). All patients will be followed for safety for 30 days after the last dose of Ribociclib/placebo.
3. Follow-Up phase: Participants will be followed post treatment phase for detection of recurrence and survival. They will continue to receive ET alone for an additional 36 months, until recurrence of disease, unacceptable side effects or withdrawal of consent. The total duration of participation in the study will be between 61 to 77 months depending on when the last participant who entered the study completes the study.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1395
Date of REC Opinion
2 Nov 2017
REC opinion
Further Information Favourable Opinion