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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2023
  • participants needed
    460
  • sponsor
    Eli Lilly and Company
Updated on 12 March 2021
cancer
breast cancer
everolimus
growth factor
endocrine therapy
metastasis
hormone therapy
pertuzumab
epidermal growth factor receptor
HER2
EGFR
trastuzumab
human epidermal growth factor
fulvestrant
stage iv breast cancer
erbb2
epidermal growth factor
aromatase inhibitor
abemaciclib
anastrozole
exemestane
her2-negative breast cancer
letrozole
growth factors
immunostimulant
her2/neu-negative breast cancer
immunological adjuvant

Summary

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.

Details
Condition Endometrial Carcinoma, Uterine Cancer, Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer Diagnosis, Stage IV Breast Cancer, Endometrial Cancer, breast carcinoma, cancer, breast
Treatment Everolimus, Trastuzumab, Abemaciclib, Alpelisib, LY3484356, Aromatase Inhibitor (AI)
Clinical Study IdentifierNCT04188548
SponsorEli Lilly and Company
Last Modified on12 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or cancer, breast or Endometrial Carcinoma or breast carcinoma or Stage IV Breast Cancer or Uterine Cancer or...?
Do you have any of these conditions: Advanced Breast Cancer or cancer, breast or Breast Cancer or Breast Cancer Diagnosis or Endometrial Cancer or breast carcinoma or Metastatic Breast Ca...?
Do you have any of these conditions: cancer, breast or Endometrial Carcinoma or Stage IV Breast Cancer or Endometrial Cancer or Breast Cancer or breast carcinoma or Uterine Cancer or Meta...?
Do you have any of these conditions: Advanced Breast Cancer or breast carcinoma or Breast Cancer or cancer, breast or Stage IV Breast Cancer or Uterine Cancer or Metastatic Breast Cancer ...?
Do you have any of these conditions: cancer, breast or Endometrial Cancer or Breast Cancer or Breast Cancer Diagnosis or Endometrial Carcinoma or Metastatic Breast Cancer or Stage IV Brea...?
Do you have any of these conditions: Breast Cancer Diagnosis or Endometrial Cancer or cancer, breast or breast carcinoma or Breast Cancer or Metastatic Breast Cancer or Advanced Breast Ca...?
Do you have any of these conditions: breast carcinoma or Advanced Breast Cancer or Metastatic Breast Cancer or Uterine Cancer or Breast Cancer or Endometrial Carcinoma or Stage IV Breast ...?
Do you have any of these conditions: Endometrial Cancer or Breast Cancer or cancer, breast or Metastatic Breast Cancer or Endometrial Carcinoma or Advanced Breast Cancer or breast carcino...?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or Uterine Cancer or Stage IV Breast Cancer or cancer, breast or Metastatic Breast Cancer or Endometrial Canc...?
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Endometrial Cancer or Metastatic Breast Cancer or Advanced Breast Cancer or Uterine Cancer or Stage IV Breast Cancer or Breast Cancer Diagnosis or bre...?
Do you have any of these conditions: Stage IV Breast Cancer or Breast Cancer or Uterine Cancer or Endometrial Cancer or Metastatic Breast Cancer or Advanced Breast Cancer or Breast Cancer...?
Do you have any of these conditions: Endometrial Cancer or Endometrial Carcinoma or cancer, breast or Uterine Cancer or Advanced Breast Cancer or breast carcinoma or Stage IV Breast Cance...?
Do you have any of these conditions: breast carcinoma or Breast Cancer Diagnosis or Uterine Cancer or Stage IV Breast Cancer or Advanced Breast Cancer or Endometrial Cancer or cancer, bre...?
Do you have any of these conditions: Advanced Breast Cancer or breast carcinoma or cancer, breast or Breast Cancer or Breast Cancer Diagnosis or Uterine Cancer or Metastatic Breast Cancer...?
Do you have any of these conditions: Stage IV Breast Cancer or Breast Cancer Diagnosis or Advanced Breast Cancer or breast carcinoma or Uterine Cancer or cancer, breast or Breast Cancer o...?
Do you have any of these conditions: Metastatic Breast Cancer or Breast Cancer or Uterine Cancer or Endometrial Cancer or Advanced Breast Cancer or Endometrial Carcinoma?
Gender: Male or Female
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
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 (PIK3C) 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 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

Exclusion Criteria

Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
Participants must not have another serious medical condition
Participants must not have cancer of the central nervous system that is unstable
Participants must not be pregnant or breastfeeding
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