A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT02246621
• Date of registration: 18/09/2014
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer MONARCH 3
• Scientific 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
• Date of first enrolment: November 6, 2014
• Target sample size: 493
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02246621
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Puerto Rico, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) breast cancer

- Have locoregionally recurrent disease not amenable to resection or radiation therapy
with curative intent or metastatic disease

- Have postmenopausal status

- Have either measurable disease or nonmeasurable bone-only disease

- Have a performance status =1 on the Eastern Cooperative Oncology Group (ECOG) scale

- Have adequate organ function

- Have discontinued previous localized radiotherapy for palliative purposes or for lytic
lesions at risk of fracture prior to randomization and recovered from the acute
effects of therapy

- Are able to swallow capsules

Exclusion Criteria:

- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis

- Have inflammatory breast cancer

- Have clinical evidence or a history of central nervous system (CNS) metastasis

- Are currently receiving or have previously received endocrine therapy for
locoregionally recurrent or metastatic breast cancer

- Have received prior (neo)adjuvant endocrine therapy with a disease-free interval =12
months from completion of treatment

- Are currently receiving or have previously received chemotherapy for locoregionally
recurrent or metastatic breast cancer

- Have received prior treatment with everolimus

- Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or
participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is
still blinded)

- Have initiated bisphosphonates or approved receptor activator of nuclear factor
kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization

- Are currently receiving an investigational drug in a clinical trial or participating
in any other type of medical research judged not to be scientifically or medically
compatible with this study

- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of randomization for a nonmyelosuppressive or
myelosuppressive agent, respectively

- Have had major surgery within 14 days prior to randomization



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Abemaciclib

Drug: Anastrozole

Drug: Placebo

Drug: Letrozole

Primary Outcome(s)

Progression Free Survival (PFS) [Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)]

Secondary Outcome(s)

Duration of Response (DoR) [Time Frame: CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)]

Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire [Time Frame: Baseline, End of Study (Up to 32 Months)]

Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores [Time Frame: Baseline, End of Study (Up to 32 Months)]

Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR]) [Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)]

Overall Survival (OS) [Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)]

Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale [Time Frame: Baseline, End of Study (Up to 32 Months)]

Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-8)] of Abemaciclib and Its Metabolites M2 and M20 [Time Frame: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose]

Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value [Time Frame: Baseline, End of Study (Up to 32 Months)]

Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) [Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)]

PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20 [Time Frame: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose]

Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores [Time Frame: Baseline, End of Study (Up to 32 Months)]

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [Time Frame: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)]

Secondary ID(s)

I3Y-MC-JPBM

15417

2014-001502-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02246621