Breast Cancer Clinical Trial
— EMBEROfficial title:
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
Verified date | May 2024 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | December 2027 |
Est. primary completion date | June 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 a (PIK3Ca) 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Cancer Research SA | Adelaide | South Australia |
Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
Australia | Breast Cancer Research Centre-WA | Nedlands | Western Australia |
Australia | Linear Clinical Research | Nedlands | Western Australia |
Australia | Calvary Mater Newcastle | Waratah | New South Wales |
Belgium | Institut Jules Bordet | Anderlecht | Bruxelles-Capitale, Région De |
Belgium | Antwerp University Hospital | Edegem | Antwerpen |
Belgium | UZ Leuven | Leuven | |
France | Institut Curie | Paris | |
France | Institut de cancérologie Strasbourg Europe (ICANS) | Strasbourg | |
Japan | Hyogo Cancer Center | Akashi | Hyogo |
Japan | National Cancer Center Hospital | Chuo-ku | Tokyo |
Korea, Republic of | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | Seoul, Korea |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | Korea |
Spain | Hospital Clínic de Barcelona | Barcelona | Catalunya [Cataluña] |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad De |
Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Universitario HM Sanchinarro | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Fundación Instituto Valenciano de Oncología | Valencia | |
Spain | Hospital Clínico Universitario de Valencia | Valencia | Valenciana, Comunitat |
Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | National Cheng-Kung Uni. Hosp. | Tainan | |
Taiwan | Mackay Memorial Hospital | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
United States | Winship Cancer Center Emory University | Atlanta | Georgia |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Beverly Hills Cancer Center | Beverly Hills | California |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | The University of Vermont Medical Center Inc. | Burlington | Vermont |
United States | University of North Carolina School of Medicine | Chapel Hill | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Memorial Sloan Kettering Cancer Center | Commack | New York |
United States | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
United States | UT Southwestern Med Center | Dallas | Texas |
United States | Duke University | Durham | North Carolina |
United States | Inova Schar Cancer Institute | Fairfax | Virginia |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | UPMC Hillman Cancer Center Harrisburg | Harrisburg | Pennsylvania |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Community Cancer Center North | Indianapolis | Indiana |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | Asante Rogue Regional Medical Center | Medford | Oregon |
United States | Minnesota Oncology/Hematology PA | Minneapolis | Minnesota |
United States | Memorial Sloan Kettering - Bergen | Montvale | New Jersey |
United States | SCRI Oncology Partners | Nashville | Tennessee |
United States | Tennessee Oncology Nashville | Nashville | Tennessee |
United States | Vanderbilt Health One Hundred Oaks | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | University of Oklahoma Health Sciences Center, Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | University of California, Irvine | Orange | California |
United States | Lake Nona DDU | Orlando | Florida |
United States | Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Wilmot Cancer Institute | Rochester | New York |
United States | Washington University | Saint Louis | Missouri |
United States | South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas |
United States | UCSF Medical Center at Mission Bay | San Francisco | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Highlands Oncology Group | Springdale | Arkansas |
United States | Minnesota Oncology/Hematology PA | The Woodlands | Texas |
United States | Oncology and Hematology Associates of Southwest Virginia Inc | The Woodlands | Texas |
United States | Texas Oncology - San Antonio Medical Center | The Woodlands | Texas |
United States | US Oncology | The Woodlands | Texas |
United States | USO-Rocky Mountain Cancer Center | The Woodlands | Texas |
United States | Texas Oncology - Tyler | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Australia, Belgium, France, Japan, Korea, Republic of, Spain, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities | Number of Participants with DLTs and DLT-Equivalent Toxicities | Baseline through Cycle 1 (21/28 Day Cycle) | |
Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356 | PK: AUC of LY3484356 | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) | |
Secondary | PK: Maximum Concentration (Cmax) of LY3484356 | PK: Cmax of LY3484356 | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) | |
Secondary | PK: AUC of LY3484356 in Combination with Other Anticancer Therapies | PK: AUC of LY3484356 in Combination with Other Anticancer Therapies | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) | |
Secondary | PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies | PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies | Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles) | |
Secondary | Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1 | Baseline through Disease Progression or Death (Estimated up to 28 Months) | |
Secondary | Duration of Response (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 | 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 | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 28 Months) | |
Secondary | Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response (BOR) of CR, PR, and Stable Disease (SD) as per RECIST v1.1 | DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1 | Baseline through Measured Progressive Disease (Estimated up to 28 Months) | |
Secondary | Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD lasting =24 weeks 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 | Baseline through Measured Progressive Disease (Estimated up to 28 Months) | |
Secondary | Progression Free Survival (PFS): Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier | PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier | Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 28 Months) |
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