Neoplasms

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200 mg abemaciclib given twice a day (BID) orally with a meal.

200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.

200 mg abemaciclib given twice a day (BID) orally without regard for food.

Abemaciclib

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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.

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

An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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).

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.

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

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

Percentage of participants who discontinue treatment due to diarrhea

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

PK: Mean steady state exposure of abemaciclib

PK: Mean steady state exposure of abemaciclib metabolite LSN2839567

PK: Mean steady state exposure of abemaciclib metabolite LSN3106726

Eli Lilly and Company

All participants who received at least one dose of study drug.

200 mg Abemaciclib With a Meal

200 mg Abemaciclib Without a Meal

200 mg Abemaciclib Without Regard to Food

Total

Age, Continuous

Sex: Female, Male

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Turkey

Belgium

Australia

Spain

Russia

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200 mg abemaciclib given twice a day (BID) orally with a meal..

Percentage of Participants With Severe Diarrhea (≥ Grade 3)

Percentage of Participants With Prolonged Grade 2 Diarrhea

Percentage of Participants With Dose Reductions Due to Diarrhea

Percentage of Participants With Dose Interruptions Due to Diarrhea

Percentage of Participants Who Discontinue Treatment Due to Diarrhea

Percentage of Participants Utilizing Antidiarrheals

Cycle 1: Day 15

Cycle 2: Day 1

Cycle 2: Day 15

Cycle 3: Day 1

All participants who received at least one dose of study drug who had evaluable PK data.

Spots Global Cancer Trial Database for A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

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