Floatz Rating
CC43/100
Confidence
Indicative
Sponsor
Eisai Inc.
Modality
UNKNOWN
Development Phase
Phase 1
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
28Moderate confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT04288089CT.gov 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 | — | Active Not Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
95Indicative
Detailed axis rationale is planned and will be published soon.
Same indication · HER2 Positive Breast Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| h3b-6545 (this asset) | Eisai Inc. | P1 | CC · 43 |
| Trastuzumab | SWOG Cancer Research Network | P4 | BB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Ribociclib | Danish Breast Cancer Cooperative Group | P3 | BB |
| Capecitabine | MedSIR | P4 | BB |
| Docetaxel | Ohio State University Comprehensive Cancer Center | P3 | BB |
| Cyclophosphamide | National University Hospital, Singapore | P3 | BB |
| Vinorelbine Ditartrate | Fudan University | P3 | BB |
| Everolimus | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | P3 | BB |
+42 more in the HER2 Positive Breast Carcinoma cohort
Other indications for h3b-6545
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Neoplasm | — | P1/2 | CCC · 53 |
| Breast Adenocarcinoma | — | P1/2 | CCC · 50 |
| Breast Cancer | — | P1/2 | CC · 42 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. h3b-6545 in HER2 Positive Breast Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/h3b-6545-her2-positive-breast-carcinoma
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