Status:
COMPLETED
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Lead Sponsor:
Eisai Inc.
Conditions:
Breast Neoplasms
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estro...
Eligibility Criteria
Inclusion
- Pre- or post-menopausal women.
- ER-positive, HER2-negative breast cancer that is advanced or metastatic.
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate bone marrow and organ function.
- 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.
- 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
- Participants must have at least one measurable lesion.
- Participant with inflammatory breast cancer.
- Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only).
- Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03250676
Start Date
August 23 2017
End Date
October 26 2023
Last Update
February 25 2025
Active Locations (39)
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1
Western Regional Medical Center, Inc., DBA Cancer Treatment Centers of America, Phoenix
Goodyear, Arizona, United States, 85338
2
University of California Los Angeles
Los Angeles, California, United States, 90404
3
University of California San Francisco
San Francisco, California, United States, 94158
4
University of Colorado - Cancer Center
Aurora, Colorado, United States, 80045