West Cancer Center

BREAST: Neoadjuvant; HR+; HER2-; "neoMONARCH"

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

Title

Eli Lilly I3Y-MC-JPBY

Study Title

Site Link

NCT02441946

Malignancy

Breast, Early Breast Cancer

Stage

Stage 2

Disease Setting

Neoadjuvant

Line Of Therapy

N/A

Investigational Agent

Abemaciclib

Drug Class

CDK4/6 inhibitor

Greg Vidal, MD, PhD

Sponsor

Eli Lilly and Company

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

NCT02441946

Key Eligibility Criteria Details

Postmenopausal adenocarcinoma of breast

Tumor >1cm in diameter

HR+, HER2-

Neoadjuvant endocrine monotherapy deemed to be suitable therapy

Suitability for baseline core biopsy

No bilateral breast cancer

No inflammatory breast cancer

No metastatic disease

No prior systemic therapy or XRT in same breast as being currently treated

No prior anti-estrogen therapy

Objective

Primary- Change from Baseline to 2 weeks in Ki67 expression: Secondary- pCR rate, clinical and radiologic ORR, toxicity, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER positive (ER+) or PR positive (PR+) , HER2 negative

Dosing Frequency

Abemaciclib bid x16 weeks and/or anastrazole daily x16 weeks

Control Agents

Study Protocol

Randomized