EMBER: A Study of LY3484356 in Patients with Breast or Other Non-Breast Cancers - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a new investigational drug called LY3484356 (study drug) is a safe and effective treatment for metastatic ER+/HER2+ breast cancer. We will combine the study drug with either trastuzumab or trastuzumab + abemaciclib in the study.

What is the Condition Being Studied?

Metastatic ER+/HER2+ Breast Cancer

Who Can Participate in the Study?

Adults who:
- Are diagnosed with metastatic ER+/HER2+ breast cancer
- Experienced worsening of disease when taking endocrine therapy

For more information about who can join this study, please contact the study team at 919-660-1278.

Age Group
Adults

What is Involved?

If you choose to join this study you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- One group will take the study drug with trastuzumab
-- The other group will take the study drug with trastuzumab and abemaciclib
- Have physical exams
- Have blood draws
- Have imaging scans

The study drug and abemaciclib are taken by mouth daily during the treatment period. Trastuzumab is given as an infusion once every 21 days during the treatment period.

You will return to our clinic after your treatment ends for follow-up visits to see how you are doing.

Study Details

Full Title
EMBER: Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00104648
NCT: NCT04188548
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698