NCT03703466 is a Phase 2 clinical trial of Abemaciclib in Metastatic Breast Cancer, sponsored by Eli Lilly and Company.

Who is sponsoring NCT03703466?

NCT03703466 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT03703466?

Interventions in NCT03703466: Abemaciclib.

What condition does NCT03703466 study?

NCT03703466 studies Metastatic Breast Cancer.

Is NCT03703466 still recruiting?

NCT03703466 is currently completed. Last updated 2 April 2024.

Are results published for NCT03703466?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-04-02 · How we verify

NCT03703466

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

Completed Phase 2 Results posted Last updated 2 April 2024

What this trial tests

Phase 2 trial testing Abemaciclib in Metastatic Breast Cancer in 72 participants. Completed in 9 March 2023.

Timeline

28 November 2018

Primary endpoint
29 July 2019

9 March 2023

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	28 November 2018
Primary completion	29 July 2019
Estimated completion	9 March 2023
Sites	15 locations across Russia, Belgium, Australia, Turkey (Türkiye), Spain

Drugs / interventions tested

Abemaciclib (abemaciclib) — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Severe Diarrhea (≥ Grade 3) Primary · Cycle 3 (28 Days Cycle)

Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).

Group	Value	95% CI
200 mg Abemaciclib With a Meal	4.2
200 mg Abemaciclib Without a Meal	0
200 mg Abemaciclib Without Regard to Food	0

Percentage of Participants With Prolonged Grade 2 Diarrhea Primary · Cycle 3 (28 Days Cycle)

Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.

Group	Value	95% CI
200 mg Abemaciclib With a Meal	8.3
200 mg Abemaciclib Without a Meal	17.4
200 mg Abemaciclib Without Regard to Food	20.8

Percentage of Participants With Dose Reductions Due to Diarrhea Primary · Cycle 3 (28 Days Cycle)

Percentage of participants with dose reductions due to diarrhea during first 3 cycles.

Group	Value	95% CI
200 mg Abemaciclib With a Meal	16.7
200 mg Abemaciclib Without a Meal	8.7
200 mg Abemaciclib Without Regard to Food	12.5

Percentage of Participants With Dose Interruptions Due to Diarrhea Primary · Cycle 3 (28 Days Cycle)

Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.

Group	Value	95% CI
200 mg Abemaciclib With a Meal	16.7
200 mg Abemaciclib Without a Meal	4.3
200 mg Abemaciclib Without Regard to Food	8.3

Percentage of Participants Who Discontinue Treatment Due to Diarrhea Primary · Cycle 3 (28 Days Cycle)

Percentage of participants who discontinue treatment due to diarrhea

Group	Value	95% CI
200 mg Abemaciclib With a Meal	0
200 mg Abemaciclib Without a Meal	0
200 mg Abemaciclib Without Regard to Food	0

Percentage of Participants Utilizing Antidiarrheals Primary · Cycle 3 (28 Days Cycle)

Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.

Group	Value	95% CI
200 mg Abemaciclib With a Meal	95.8
200 mg Abemaciclib Without a Meal	91.3
200 mg Abemaciclib Without Regard to Food	95.8

Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib Secondary · Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

PK: Mean steady state exposure of abemaciclib

Cycle 1: Day 15

Group	Value	95% CI
200 mg Abemaciclib With a Meal	305	± 198
200 mg Abemaciclib Without a Meal	369	± 64
200 mg Abemaciclib Without Regard to Food	356	± 75

Cycle 2: Day 1

Group	Value	95% CI
200 mg Abemaciclib With a Meal	320	± 91
200 mg Abemaciclib Without a Meal	280	± 99
200 mg Abemaciclib Without Regard to Food	190	± 284

Cycle 2: Day 15

Group	Value	95% CI
200 mg Abemaciclib With a Meal	77.4	± 731
200 mg Abemaciclib Without a Meal	345	± 51
200 mg Abemaciclib Without Regard to Food	223	± 250

Cycle 3: Day 1

Group	Value	95% CI
200 mg Abemaciclib With a Meal	135	± 896
200 mg Abemaciclib Without a Meal	330	± 54
200 mg Abemaciclib Without Regard to Food	85.4	± 498

PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 Secondary · Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

PK: Mean steady state exposure of abemaciclib metabolite LSN2839567

Cycle 1 Day 15

Group	Value	95% CI
200 mg Abemaciclib With a Meal	139	± 109
200 mg Abemaciclib Without a Meal	129	± 48
200 mg Abemaciclib Without Regard to Food	159	± 61

Cycle 2 Day 1

Group	Value	95% CI
200 mg Abemaciclib With a Meal	125	± 62
200 mg Abemaciclib Without a Meal	109	± 84
200 mg Abemaciclib Without Regard to Food	96.3	± 127

Cycle 2 Day 15

Group	Value	95% CI
200 mg Abemaciclib With a Meal	50.4	± 276
200 mg Abemaciclib Without a Meal	121	± 45
200 mg Abemaciclib Without Regard to Food	112	± 79

Cycle 3 Day 1

Group	Value	95% CI
200 mg Abemaciclib With a Meal	89.4	± 110
200 mg Abemaciclib Without a Meal	125	± 48
200 mg Abemaciclib Without Regard to Food	61.7	± 122

PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 Secondary · Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

PK: Mean steady state exposure of abemaciclib metabolite LSN3106726

Cycle 1 Day 15

Group	Value	95% CI
200 mg Abemaciclib With a Meal	231	± 120
200 mg Abemaciclib Without a Meal	242	± 38
200 mg Abemaciclib Without Regard to Food	287	± 63

Cycle 2 Day 1

Group	Value	95% CI
200 mg Abemaciclib With a Meal	230	± 59
200 mg Abemaciclib Without a Meal	210	± 57
200 mg Abemaciclib Without Regard to Food	152	± 222

Cycle 2 Day 15

Group	Value	95% CI
200 mg Abemaciclib With a Meal	80.5	± 377
200 mg Abemaciclib Without a Meal	221	± 31
200 mg Abemaciclib Without Regard to Food	182	± 112

Cycle 3 Day 1

Group	Value	95% CI
200 mg Abemaciclib With a Meal	146	± 174
200 mg Abemaciclib Without a Meal	223	± 33
200 mg Abemaciclib Without Regard to Food	107	± 172

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline until end of the follow-up (Up To 44 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200 mg Abemaciclib With a Meal

Serious: 3/24 (13%)

Deaths: 3/24

200 mg Abemaciclib Without a Meal

Serious: 5/23 (22%)

Deaths: 4/23

200 mg Abemaciclib Without Regard to Food

Serious: 8/24 (33%)

Deaths: 1/24

Serious adverse events (19 terms)

Reaction	System	200 mg Abemaciclib With a …	200 mg Abemaciclib Without…	200 mg Abemaciclib Without…
Nausea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Non-cardiac chest pain	General disorders	—	—	—
Cholangitis	Hepatobiliary disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Cauda equina syndrome	Nervous system disorders	—	—	—
Guillain-barre syndrome	Nervous system disorders	—	—	—
Renal failure	Renal and urinary disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Superficial vein thrombosis	Vascular disorders	—	—	—

Other adverse events (185 terms — click to expand)

Reaction	System	200 mg Abemaciclib With a …	200 mg Abemaciclib Without…	200 mg Abemaciclib Without…
Diarrhoea	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Fatigue	General disorders	—	—	—
Platelet count decreased	Investigations	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
White blood cell count decreased	Investigations	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Asthenia	General disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Mucosal inflammation	General disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Blood creatinine increased	Investigations	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Weight decreased	Investigations	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—

Most-reported serious reactions: Nausea, Vomiting, Pleural effusion, Anaemia, Atrial fibrillation, Diarrhoea, Pancreatitis, Non-cardiac chest pain.

Data from ClinicalTrials.gov NCT03703466 adverse events section.

Sponsor's own description

The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer.
Sobhani N, D'Angelo A, Pittacolo M, Roviello G, et al · · 2019 · cited 117× · PMID 30959874 · DOI 10.3390/cells8040321
Stem cell therapy: A paradigm shift in breast cancer treatment.
Khan S, Suryavanshi M, Kaur J, Nayak D, et al · · 2021 · cited 13× · PMID 34367480 · DOI 10.4252/wjsc.v13.i7.841
An open label, randomized phase 2 trial assessing the impact of food on the tolerability of abemaciclib in patients with advanced breast cancer.
Lim E, Boyle F, Okera M, Loi S, et al · · 2022 · cited 5× · PMID 35915198 · DOI 10.1007/s10549-022-06690-5
The Role of PIM Kinases in Pediatric Solid Tumors.
Julson JR, Marayati R, Beierle EA, Stafman LL. · · 2022 · cited 5× · PMID 35892829 · DOI 10.3390/cancers14153565
An open label, randomized phase 2 trial assessing the impact of food on the tolerability of abemaciclib in patients with Advanced Breast Cancer
Lim E, Boyle F, Okera M, Loi S, et al · · 2022 · DOI 10.21203/rs.3.rs-1440521/v1

Verify or expand the search:

Other trials of Abemaciclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT07428018 — Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Onco · Phase 2 · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT06498648 — Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tis · Phase 1, PHASE2 · recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03703466 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 2 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03703466.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing