A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02441946
• Date of registration: 08/05/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer neoMONARCH
• Scientific title: 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
• Date of first enrolment: August 2015
• Target sample size: 224
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02441946
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Canada, Germany, Italy, Korea, Republic of, Netherlands, Spain, Taiwan, 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 postmenopausal status.

- Adenocarcinoma of the breast.

- Breast tumor =1 centimeter (cm) in diameter, HR+, HER2-.

- Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.

- Primary breast cancer that is suitable for baseline core biopsy.

- Have adequate organ function.

Exclusion Criteria:

- Bilateral invasive breast cancer.

- Metastatic breast cancer (local spread to axillary lymph nodes is permitted).

- Inflammatory breast cancer.

- Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in
the same breast as currently being treated.

- Prior radiotherapy to the ipsilateral chest wall for any malignancy.

- Prior anti-estrogen therapy.



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

Health Condition(s) or Problem(s) studied

Hormone Receptor Positive Tumor

Early-Stage Breast Carcinoma

Breast Cancer

Intervention(s)

Drug: Loperamide

Drug: Abemaciclib

Drug: Anastrozole

Primary Outcome(s)

Percent Change From Baseline to 2 Weeks in Ki67 Expression [Time Frame: Baseline, 2 Weeks]

Secondary Outcome(s)

Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response [Time Frame: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)]

PK: Apparent Volume of Distribution of Abemaciclib [Time Frame: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose]

Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response [Time Frame: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)]

Percentage of Participants With Pathologic Complete Response (pCR) [Time Frame: From Start of Treatment Up to 16 Weeks]

Pharmacokinetics (PK): Apparent Clearance of Abemaciclib [Time Frame: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose]

Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Time Frame: Baseline, 2 Weeks]

Secondary ID(s)

I3Y-MC-JPBY

2014-005486-75

15805

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/01/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02441946