Aromatase Inhibitor (AI): Anastrozole or Exemestane or Letrozole administered orally (physician choice)
Pertuzumab: Administered intravenously
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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 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 in any setting.
* Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.
* Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease.
* Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen.
* Part E: Participants must not have received more than 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 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
Primary outcome measure(s)
Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities — Baseline through Cycle 1 (21/28 Day Cycle) Number of Participants with DLTs and DLT-Equivalent Toxicities
Trial sites (74)
Facility
City
Region
Status
Banner MD Anderson Cancer Center
Gilbert
Arizona
Mayo Clinic in Arizona - Phoenix
Phoenix
Arizona
Highlands Oncology Group
Springdale
Arkansas
Beverly Hills Cancer Center
Beverly Hills
California
University of California, Irvine
Orange
California
UCSF Medical Center at Mission Bay
San Francisco
California
Mayo Clinic in Florida
Jacksonville
Florida
Lake Nona DDU
Orlando
Florida
Winship Cancer Center Emory University
Atlanta
Georgia
Community Cancer Center North
Indianapolis
Indiana
Johns Hopkins University
Baltimore
Maryland
Massachusetts General Hospital
Boston
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts
Minnesota Oncology/Hematology PA
Minneapolis
Minnesota
Mayo Clinic
Rochester
Minnesota
Washington University
St Louis
Missouri
Memorial Sloan Kettering - Bergen
Montvale
New Jersey
Memorial Sloan Kettering Cancer Center
Commack
New York
Memorial Sloan Kettering Cancer Center
New York
New York
Wilmot Cancer Institute
Rochester
New York
Duke University
Durham
North Carolina
Ohio State University Medical Center
Columbus
Ohio
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City
Oklahoma
Asante Rogue Regional Medical Center
Medford
Oregon
UPMC Hillman Cancer Center Harrisburg
Harrisburg
Pennsylvania
Rhode Island Hospital
Providence
Rhode Island
Vanderbilt Health One Hundred Oaks
Nashville
Tennessee
SCRI Oncology Partners
Nashville
Tennessee
Tennessee Oncology Nashville
Nashville
Tennessee
UT Southwestern Med Center
Dallas
Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas
Texas
University of Texas MD Anderson Cancer Center
Houston
Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio
Texas
Minnesota Oncology/Hematology PA
The Woodlands
Texas
Oncology and Hematology Associates of Southwest Virginia Inc
The Woodlands
Texas
Texas Oncology - San Antonio Medical Center
The Woodlands
Texas
US Oncology
The Woodlands
Texas
USO-Rocky Mountain Cancer Center
The Woodlands
Texas
Texas Oncology - Tyler
Tyler
Texas
The University of Vermont Medical Center Inc.
Burlington
Vermont
+ 34 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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