A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
NCT ID: NCT04288089
Last Updated: 2025-08-03
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE1
31 participants
INTERVENTIONAL
2020-04-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
Participants will receive Palbociclib 75, 100, 125 milligram (mg) capsules or tablets, orally, once daily from Days 1 to 21 followed by 7 days off treatment in 28-day cycles along with H3B-6545 150, 300, 450 mg capsules or tablets, orally, once daily from Days 1 to 28 in 28-day cycles in dose escalation part. Based on MTD or RP2D determined for H3B-6545 in combination with palbociclib in dose escalation part, participants will continue to receive study treatment in dose expansion part until PD, development of unacceptable toxicity, or withdrawal of consent (up to 24 months).
Palbociclib (75, 100, 125 milligram [mg])
Palbociclib orally, once daily (QD).
H3B-6545 (150, 300, 450 mg)
H3B-6545 orally, QD.
Interventions
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Palbociclib (75, 100, 125 milligram [mg])
Palbociclib orally, once daily (QD).
H3B-6545 (150, 300, 450 mg)
H3B-6545 orally, QD.
Eligibility Criteria
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Inclusion Criteria
2. Prior therapy in the advanced/metastatic setting
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Has adequate bone marrow and organ function
Exclusion Criteria
2. Major surgery or other locoregional treatment within 4 weeks before the 1st dose of study drug
3. Inability to take oral medication or presence of malabsorption
4. Active cardiac disease or a history of cardiac dysfunction
5. Evidence of ongoing Alcohol or Drug Abuse
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Florida Cancer Specialists South - SCRI - PPDS
Sarasota, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Nashville, Tennessee, United States
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Sarah Cannon Research Institute UK - SCRI
London, , United Kingdom
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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2019-004622-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H3B-6545-G000-102
Identifier Type: -
Identifier Source: org_study_id
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