Recruiting

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer ( EMBER )

J2J-MC-JZLA - ClinicalTrials.gov - NCT04188548

The reason for this study is to see if the study drug LY3484356 alone or in combination with abemaciclib is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
How long will I be in the trial?
Your participation in this trial could last up to 42 months, depending on your cancer type and how you and your tumor respond
Email
Recruiting

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer ( EMBER )

J2J-MC-JZLA - ClinicalTrials.gov - NCT04188548

The reason for this study is to see if the study drug LY3484356 alone or in combination with abemaciclib is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
How long will I be in the trial?
Your participation in this trial could last up to 42 months, depending on your cancer type and how you and your tumor respond
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that may have spread to other part(s) of the body and has had up to 3 lines of standard therapy and progression while on endocrine-containing therapy for ≥24 months in the adjuvant setting or ≥6 months in advanced/metastatic setting OR have endometrioid endometrial cancer (EEC) having progressed on standard of care and must have had prior platinum-containing therapy

All study parts:

Participants must be willing to provide adequate archival tissue sample

Participants must be willing to use highly effective birth control

Participants must have adequate organ function

Participants must be able to swallow capsules

Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled

Dose escalation- Participants must have one of the following: • Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following: • Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. • Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor • Cohort E4: No prior everolimus.• Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (PIK3Cα) mutation as determined by local testing. • Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies for advanced disease and prior trastuzumab, pertuzumab, and TDM-1 required in any setting. • Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.

Participants with ER+/HER2- breast cancer enrolled in this study must have either demonstrated prior sensitivity to endocrine therapy, to have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer

Participants must NOT

Participants must not have another serious medical condition

Participants must not have cancer of the central nervous system that is not stable

Participants must not be pregnant or breastfeeding

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer

What the trial is testing?

LY3484356, Abemaciclib

Could I receive a Placebo?

no

Enrollment Goal

460

Trial Dates

December 2019 - April 2023

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that may have spread to other part(s) of the body and has had up to 3 lines of standard therapy and progression while on endocrine-containing therapy for ≥24 months in the adjuvant setting or ≥6 months in advanced/metastatic setting OR have endometrioid endometrial cancer (EEC) having progressed on standard of care and must have had prior platinum-containing therapy

All study parts:

Participants must be willing to provide adequate archival tissue sample

Participants must be willing to use highly effective birth control

Participants must have adequate organ function

Participants must be able to swallow capsules

Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled

Dose escalation- Participants must have one of the following: • Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following: • Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. • Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor • Cohort E4: No prior everolimus.• Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (PIK3Cα) mutation as determined by local testing. • Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies for advanced disease and prior trastuzumab, pertuzumab, and TDM-1 required in any setting. • Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.

Participants with ER+/HER2- breast cancer enrolled in this study must have either demonstrated prior sensitivity to endocrine therapy, to have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer

Participants must NOT

Participants must not have another serious medical condition

Participants must not have cancer of the central nervous system that is not stable

Participants must not be pregnant or breastfeeding

Trial Summary

Conditions the trial is for

Metastatic Breast Cancer

What the trial is testing?

LY3484356, Abemaciclib

Could I receive a Placebo?

no

Enrollment Goal

460

Trial Dates

December 2019 - April 2023

Trial Phase

1

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Trial Locations

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Metastatic Breast Cancer Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?