Monarch 3: Breast Cancer in Postmenopausal Women (JPBM Study)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer with No Prior Systemic Therapy in this Disease Setting
IRAS ID
164539
Contact name
Stephen Johnson
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2014-001502-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 13 days
Research summary
Breast cancer is one of the most common cancers in women. At early stage, the breast cancer is treatable, but when cancer spreads to other areas, survival rate is generally only 2 to 3 years (Cardoso et al. 2012). The majority of invasive breast cancers are hormone receptor positive (HR+) and endocrine therapy (hormone based therapy such as Anastrozole or Letrozole) is commonly used as the first line of treatment for postmenopausal women.
The MONARCH-3 study is finding out if endocrine therapy in combination with Abemaciclib (study medication) could slow/stop tumour growth thus prevent cancer from further progression.
To be eligible to participate in this study patients have to be postmenopausal and have HR+/HR2- locally advanced or metastatic breast cancer. The whole study will last for about 6 years and patients can stay in the study for as long as they are benefiting from the study treatment.
Study assessments will include: Physical examinations, Questionnaire completion, Blood tests, ECG and radiological scans (CT, MRI, X-ray and bone scan).
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0016
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion