Skip to main content
OpenTrials
Completed

NCT Number: NCT02441946

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

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Early-Stage Breast Carcinoma Hormone Receptor Positive Tumor Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abemaciclib

Drug

Administered orally

Other names: LY2835219

Loperamide

Drug

Administered orally

Anastrozole

Drug

Administered orally

Primary outcomes

  1. Percent Change From Baseline to 2 Weeks in Ki67 Expression

    Time frame: Baseline, 2 Weeks

    Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.

Secondary outcomes

  1. Percentage of Participants With Pathologic Complete Response (pCR)

    Time frame: From Start of Treatment Up to 16 Weeks

    pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.

  2. 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)

    Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.

  3. 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)

    Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.

  4. 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

    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, emotional, cognitive, or social functioning), global health status and symptom scales of fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.

  5. 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

    Abemaciclib apparent clearance (CL/F) was calculated by population nonlinear mixed effects modeling (NONMEM) using all available data spanning cycles 1 and cycles 3-5.

  6. 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

    Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: neoMONARCH

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
May 12, 2015
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.