A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer (MONARCH plus)

NCT02763566 Phase 3 ACTIVE_NOT_RECRUITING Results posted

The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	463
Start date	2016-12-05
Completion	2028-03

Conditions

• Breast Cancer

Interventions

• Abemaciclib
• Anastrozole
• Letrozole
• Placebo
• Fulvestrant

Primary outcomes

• Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI) — Randomization to Measured Progressive Disease or Death (up to 26 Months)
  Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Patients who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.

Countries

Brazil, China, India, South Africa