Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

500

Study ID:

NCT04188548

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 74 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Contact
480-256-6444
Shakeela Bahadur
Principal Investigator
Mayo Clinic Hospital
Phoenix Arizona, 85054, United States More Info
Contact
480-342-7390
Brenda Ernst
Principal Investigator
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States More Info
Contact
479-587-1700
Joseph T Beck
Principal Investigator
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States More Info
Contact
310-432-8941
Linnea I Chap
Principal Investigator
Cedars Sinai Medical Center
Los Angeles California, 90048, United States More Info
Contact
310-967-2700
Reva Basho
Principal Investigator
Univ of California Irvine College of Medicine
Orange California, 92868, United States More Info
Contact
714-456-8614
Ritesh Parajuli
Principal Investigator
UCSF Medical Center at Mission Bay
San Francisco California, 94158, United States More Info
Contact
415-353-7618
Hope S Rugo
Principal Investigator
Rocky Mountain Cancer Center
Aurora Colorado, 80012, United States More Info
Contact
303-418-7600
Manojkumar Bupathi
Principal Investigator
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
Contact
904-953-0707
Kostandinos Sideras
Principal Investigator
Lake Nona DDU
Orlando Florida, 32827, United States More Info
Contact
689-216-8500
Cesar Augusto Prez Batista
Principal Investigator
Winship Cancer Center Emory University
Atlanta Georgia, 30322, United States More Info
Contact
4042510641
Manali Ajay Bhave
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Contact
312-503-5488
Daniela Matei
Principal Investigator
Community Health Network
Indianapolis Indiana, 46250, United States More Info
Contact
317-278-8845
Bert H O'Neil
Principal Investigator
Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Contact
410-955-8847
Jessica Tao
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Contact
617-724-4800
Aditya Bardia
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Contact
617-632-3201
Rinath Jeselsohn
Principal Investigator
Minnesota Oncology/Hematology PA
Minneapolis Minnesota, 55404, United States More Info
Contact
612-884-6300
Timothy G. Larson
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Contact
507-293-0462
Karthik V Giridhar
Principal Investigator
Washington University Medical School
Saint Louis Missouri, 63110, United States More Info
Contact
314-362-9383
Cynthia Ma
Principal Investigator
Memorial Sloan Kettering Cancer Center
Commack New York, 11725, United States More Info
Contact
646-888-5145
Komal Jhaveri
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Contact
646-888-4545
Komal Jhaveri
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Contact
646-888-5145
Komal Jhaveri
Principal Investigator
University of Rochester School of Medicine
Rochester New York, 14642, United States More Info
Contact
585-486-0584
Ajay Dhakal
Principal Investigator
University of North Carolina
Chapel Hill North Carolina, 27599, United States More Info
Contact
919-966-4431
Lisa A Carey
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Contact
919-668-5247
Sarah Sammons
Principal Investigator
Ohio State University Medical Center
Columbus Ohio, 43210, United States More Info
Contact
614-366-4741
Nicole Williams
Principal Investigator
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Contact
4052718001
Debra Lynn Richardson
Principal Investigator
Asante Rogue Regional Medical Center
Medford Oregon, 97504, United States More Info
Contact
541-774-5853
Aleksandra Sander
Principal Investigator
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States More Info
Contact
4126412107
Adam Matthew Brufsky
Principal Investigator
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Contact
401-444-8856
Don Dizon
Principal Investigator
Sarah Cannon Research Institute SCRI
Nashville Tennessee, 37203, United States More Info
Contact
615-329-7274
SMO Sarah Cannon Research Inst.
Principal Investigator
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States More Info
Contact
615-329-7274
Erika Hamilton
Principal Investigator
Henry-Joyce Cancer Clinic
Nashville Tennessee, 37232, United States More Info
Contact
615-498-5165
Sonya Reid
Principal Investigator
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Contact
2143701000
Cynthia R.C. Osborne
Principal Investigator
UT Southwestern Med Center
Dallas Texas, 75390, United States More Info
Contact
214-648-4180
Nisha Unni
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Contact
713-745-0699
Rachel Layman
Principal Investigator
South Texas Accelerated Research Therapeutics, LLC
San Antonio Texas, 78229, United States More Info
Contact
210-593-5250
Muralidhar Beeram
Principal Investigator
Texas Oncology - San Antonio Medical Center
San Antonio Texas, 78240, United States More Info
Contact
210-656-7177
Allyson L Harroff
Principal Investigator
US Oncology
The Woodlands Texas, 77380, United States More Info
Contact
281-863-1000
SMO US Oncology
Principal Investigator
Texas Oncology - Tyler
Tyler Texas, 75702, United States More Info
Contact
903-579-9800
Donald A Richards
Principal Investigator
University of Vermont Medical Center
Burlington Vermont, 05401, United States More Info
Contact
802-656-4101
Peter A Kaufman
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Contact
571-472-4724
Kathleen Harnden
Principal Investigator
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke Virginia, 24014, United States More Info
Contact
540-774-8660
Paul D Richards
Principal Investigator
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Contact
206-606-1226
Kalyan Banda
Principal Investigator
St Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia More Info
Contact
61293555655
Elgene Lim
Principal Investigator
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia More Info
Contact
61240143564
Janine Lombard
Principal Investigator
Ashford Cancer Centre Research
Kurralta Park South Australia, 5037, Australia More Info
Contact
618 8292 2240
Meena Okera
Principal Investigator
Breast Cancer Research Centre-WA
Nedlands Western Australia, 6009, Australia More Info
Contact
61865005555
Arlene Chan
Principal Investigator
Linear Clinical Research
Nedlands Western Australia, 6009, Australia More Info
Contact
6189346 3841
Tarek Meniawy
Principal Investigator
Institut Jules Bordet
Brussel - Capital , 1070, Belgium More Info
Contact
3225413189
Philippe Aftimos
Principal Investigator
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium More Info
Contact
3238213646
Hans Prenen
Principal Investigator
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium More Info
Contact
3216344634
Patrick Neven
Principal Investigator
Institut Curie
Paris , 75248, France More Info
Contact
33156245500
Jean-Yves Pierga
Principal Investigator
Institut de Cancérologie de l'Ouest Centre René Gauducheau
Saint Herblain Cedex , 44805, France More Info
Contact
33240679977
Mario Campone
Principal Investigator
ICANS_Institut de Cancerologie Strasbourg Europe
Strasbourg , 67033, France More Info
Contact
33368768694
Laura BENDER
Principal Investigator
Gustave Roussy
Villejuif Cedex , 94805, France More Info
Contact
33142114211
Arthur Geraud
Principal Investigator
Hyogo Cancer Center
Akashi Hyogo, 673-8, Japan More Info
Contact
81120023812
Koji Matsumoto
Principal Investigator
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan More Info
Contact
81120023812
Kan Yonemori
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul Korea, 03722, Korea, Republic of More Info
Contact
82222288173
Joo Hyuk Sohn
Principal Investigator
Seoul National University Hospital
Seoul Seoul, Korea, 03080, Korea, Republic of More Info
Contact
82220720850
Seock-Ah Im
Principal Investigator
Asan Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
Contact
82230103217
Sung-Bae Kim
Principal Investigator
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Contact
82234101780
Yeon Hee Park
Principal Investigator
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain More Info
Contact
34934893000
Cristina Saura Manich
Principal Investigator
Hospital Clinic I Provincial
Barcelona , 08036, Spain More Info
Contact
0034663701518
Javier Garcia-Corbacho
Principal Investigator
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain More Info
Contact
0034914269070
Yolanda Jerez
Principal Investigator
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain More Info
Contact
34913303000
Elena Lopez Miranda
Principal Investigator
Hospital Clinico San Carlos
Madrid , 28040, Spain More Info
Contact
34913303000
Jose Angel Garcia Saenz
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Contact
34913908923
Luis Manso
Principal Investigator
Fundación Jiménez Díaz-Oncology
Madrid , 28050, Spain More Info
Contact
34915504800
Bernard Gastón Doger de Spéville Uribe
Principal Investigator
Hospital Madrid Norte Sanchinarro
Madrid , 28050, Spain More Info
Contact
34917567825
Irene Moreno Candilejo
Principal Investigator
Fundación Instituto Valenciano de Oncología
Valencia , 46009, Spain More Info
Contact
34961104624
Joaquin Gavila
Principal Investigator
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain More Info
Contact
34961973500
Valentina Gambardella
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan More Info
Contact
88673164990
Ming-Feng Hou
Principal Investigator
China Medical University Hospital
Taichung , 40447, Taiwan More Info
Hwei-Chung Wang
Principal Investigator
National Cheng-Kung Uni. Hosp.
Tainan , 704, Taiwan More Info
Kuo-Ting Lee
Principal Investigator
National Taiwan University Hospital
Taipei , 10002, Taiwan More Info
Yen-Shen Lu
Principal Investigator
Mackay Memorial Hospital
Taipei , 10449, Taiwan More Info
Contact
886975835311
Yuan-Ching Chang
Principal Investigator
Taipei Veterans General Hospital
Taipei , 11217, Taiwan More Info
Ta-Chung Chao
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

500

Study ID:

NCT04188548

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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