Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
NCT ID: NCT03250676
Last Updated: 2025-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
151 participants
INTERVENTIONAL
2017-08-23
2023-10-26
Brief Summary
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The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene \[ESR1\] Y537S mutation).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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H3B-6545 Arm 1: Dose escalation
H3B-6545
Oral capsules by mouth once daily
H3B-6545 Arm 2: Phase 2
H3B-6545
Oral capsules by mouth once daily
Interventions
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H3B-6545
Oral capsules by mouth once daily
Eligibility Criteria
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Inclusion Criteria
2. ER-positive, HER2-negative breast cancer that is advanced or metastatic.
3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy. Up to one prior chemotherapy in the metastatic setting is allowed.
4. A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6. Adequate bone marrow and organ function.
7. Participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
8. Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample.
Exclusion Criteria
2. Participant with inflammatory breast cancer.
3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only).
4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix
Goodyear, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado - Cancer Center
Aurora, Colorado, United States
Holy Cross Hospital Inc
Fort Lauderdale, Florida, United States
Florida Cancer Specialists South
Fort Myers, Florida, United States
Florida Cancer Specialists and Research Institute
Sarasota, Florida, United States
Florida Cancer Specialists North
St. Petersburg, Florida, United States
Southeastern Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Atlanta
Newnan, Georgia, United States
Carle Cancer Center
Urbana, Illinois, United States
Midwestern Regional Medical Center, Inc., DBA Cancer Treatment Centers of Americal, Chicago
Zion, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Parkland Health and Hospital System
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Tyler Oncology/Oncology PA
Tyler, Texas, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
Edog - Ico - Ppds
Angers, , France
Hopital Jean Minjoz
Besançon, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Oscar Lambret
Lille, , France
Hôpital Saint Louis
Paris, , France
Hôpital de la Pitié Salpétrière
Paris, , France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
Rennes, , France
EDOG Institut de Cancerologie de l'Ouest - PPDS
Saint-Herblain, , France
Institut de Cancérologie Strasbourg Europe
Strasbourg, , France
Institut Gustave Roussy
Villejuif, , France
The Royal Marsden NHS Foundation Trust
Chelsea, London, United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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References
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Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERalpha Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000570-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H3B-6545-A001-101
Identifier Type: -
Identifier Source: org_study_id
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