Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Jul 2017 → ongoing

Decision date (initial)

2024-03-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-509671-17-00

EudraCT number

2016-004362-26

WHO UTN

U1111-1296-8698

ClinicalTrials.gov

NCT03155997

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Therapy, Pharmacogenomic, Safety, Pharmacogenetic, Pharmacokinetic

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Conditions and MedDRA coding

Breast Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
2. The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
3. The participant must have undergone definitive surgery of the primary breast tumor.
4. The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
5. Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence: 4 or more positive axillary lymph nodes, Tumor size of at least 5 centimeters, Grade 3 defined as at least 8 points on the Bloom Richardson grading system, Ki-67 index by central analysis of ≥20% on untreated breast tissue.
6. The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
7. The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
8. Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
9. Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
10. The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
11. The participant has adequate organ function.
12. The participant is able to swallow oral medications.

Exclusion criteria 11

1. Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease.
2. Participants with inflammatory breast cancer.
3. Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded.
4. Females who are pregnant or lactating.
5. The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
6. The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
7. The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene.
8. The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
9. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE).
10. The participant has active systemic infections or viral load.
11. The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 7

Locations

16 EU/EEA countries · 191 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 96 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

19 submissions — initial application plus substantial / non-substantial modifications