A Phase 2 Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer (neoMONARCH)

• Register: EUCTR
• Last refreshed on: 19 February 2018
• Main ID: EUCTR2014-005486-75-ES
• Date of registration: 01/06/2015
• Prospective Registration: Yes
• Primary sponsor: Lilly S.A.
• Public title: A Phase 2 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 - NeoMONARCH
• Date of first enrolment: 24/07/2015
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005486-75
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Germany, Italy, Korea, Democratic People's Republic of, Netherlands, Spain, Taiwan, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
? are female and ?18 years of age ? have postmenopausal status ? adenocarcinoma of the breast ? breast tumor ?1 cm in diameter ? breast cancer that is 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

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:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Postmenopausal Women with Hormone Receptor Postive, HER2 Negative Breast Cancer
MedDRA version: 18.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Abemaciclib
Product Code: Abemaciclib
Pharmaceutical Form: Capsule
INN or Proposed INN: Abemaciclib
CAS Number: 1231929-97-7
Current Sponsor code: LY2835219
Other descriptive name: LY2835219
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Anastrozole
Product Code: L02B G03
Pharmaceutical Form: Tablet
INN or Proposed INN: Anastrozole
Other descriptive name: ANASTROZOLE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Product Name: loperamide
Pharmaceutical Form: Capsule
INN or Proposed INN: LOPERAMIDE
CAS Number: 53179-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Primary end point(s): Percent change in Ki67 expression from baseline to the core biopsy 2 weeks after the start of treatment

Timepoint(s) of evaluation of this end point: Baseline, 2 weeks

Main Objective: To compare the biological activity of abemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy by assessing the percentage change from the baseline value in Ki67 expression after 2 weeks of therapy.

Secondary Objective: ? pathologic complete response (pCR) defined as absence of invasive cancer in the breast and sampled regional lymph nodes ? clinical objective response (RECIST criteria 1.1) ? radiologic response (RECIST criteria 1.1) ? safety and tolerability ? symptom burden via the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) instrument ? pharmacokinetics (PK) of abemaciclib and anastrozole

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 16 weeks

Secondary end point(s): ? pCR defined as absence of invasive cancer in the breast and sampled regional lymph nodes ? clinical response of the breast tumor to therapy as assessed by caliper measurement ? radiologic response of the breast tumor as assessed by radiologic or ultrasound assessment ? adverse events ? EORTC QLQ-C30 ? PK of abemaciclib and its metabolites and anastrozole ? Ki67 ? Whole blood, plasma, and tissue samples will be tested for biomarkers relevant to abemaciclib and the disease state and to correlate these markers to clinical outcome and to abemaciclib.

Secondary ID(s)

I3Y-MC-JPBY

Source(s) of Monetary Support

Eli Lilly and Company