A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2020-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer

NCT03051659

Breast Cancer

COMPLETED PHASE2

A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

NCT03988114

Metastatic Breast Cancer

WITHDRAWN PHASE4

Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

NCT00005980

Breast Cancer

COMPLETED PHASE2

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

NCT05596409

Metastatic Breast Cancer

ACTIVE_NOT_RECRUITING PHASE2

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

NCT02102490

Metastatic Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3295668 Erbumine Part A

LY3295668 erbumine administered orally (Part I).

Approximately the first 10 participants enrolled in this arm will be administered midazolam.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Midazolam

Intervention Type DRUG

Administered orally.

LY3295668 Erbumine Part B

LY3295668 erbumine administered orally (Part I).

Approximately the first 10 participants enrolled in this arm will be administered midazolam.

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Midazolam

Intervention Type DRUG

Administered orally.

LY3295668 Erbumine + Endocrine Therapy Cohort 1

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Endocrine therapy

Intervention Type DRUG

Administered according to label instructions.

LY3295668 Erbumine + Endocrine Therapy Continuation Part C

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Endocrine therapy

Intervention Type DRUG

Administered according to label instructions.

LY3295668 Erbumine + Endocrine Therapy Switch Part D

LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).

Group Type EXPERIMENTAL

LY3295668 Erbumine

Intervention Type DRUG

Administered orally.

Endocrine therapy

Intervention Type DRUG

Administered according to label instructions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3295668 Erbumine

Administered orally.

Intervention Type DRUG

Endocrine therapy

Administered according to label instructions.

Intervention Type DRUG

Midazolam

Administered orally.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant must have hormone receptor positive and HER2 negative metastatic breast cancer
* Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin dependent kinase (CDK)4/6 inhibitor
* Participant must be able and willing to undergo mandatory tumor biopsy
* Participant must have normal organ function
* Participant must be able to swallow capsules

Exclusion Criteria

* Participant must not have had prior chemotherapy for mBC. Chemotherapy in the adjuvant/neoadjuvant setting is permitted
* Participant must not be currently enrolled in a clinical study
* Participant must not have another serious medical condition
* Participant must not have previously received an aurora kinase inhibitor

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No