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LY3484356

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The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer

ER expression measured by H-score immunohistochemistry (IHC)

Ki-67 index measured by percentage positive scoring by IHC

Eli Lilly and Company

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LY3484356 and abemaciclib given orally in combination with or without Aromatase Inhibitor (AI) of physician's choice (Anastrozole, Exemestane, or Letrozole) administered orally.

LY3484356 administered orally in combination with trastuzumab intravenously with or without Abemaciclib.

LY3484356 and Abemaciclib given orally with trastuzumab administered intravenously.

LY3484356 administered orally in combination with trastuzumab and pertuzumab administered intravenously.

Abemaciclib

Alpelisib

Anastrozole or Exemestane or Letrozole administered orally (physician choice)

Aromatase Inhibitor (AI)

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

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

EMBER: A 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

Number of Participants with DLTs and DLT-Equivalent Toxicities

PK: AUC of LY3484356 in Combination with Other Anticancer Therapies

PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies

ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1

DoR: Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier

DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1

CBR: Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1

PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery	NCT04647487	Breast Cancer	LY3484356	18 Years -	Eli Lilly and Company
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery	NCT04647487	Breast Cancer	LY3484356	18 Years -	Eli Lilly and Company
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer	NCT04188548	Breast Cancer Advanced Breast... Metastatic Brea... Endometrial Can...	LY3484356 Abemaciclib Everolimus Alpelisib Trastuzumab Aromatase Inhib... Pertuzumab	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly3484356

Every month we try and update this database with for ly3484356 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly3484356

Every month we try and update this database with for ly3484356 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly3484356 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.