Floatz Rating
BB65/100
Confidence
Indicative
Sponsor
Puma Biotechnology, Inc.
Modality
Small molecule
Development Phase
Phase 2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
60High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06369285CT.gov A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT02860000CT.gov Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer | — | Completed | — | — | — |
NCT02719691CT.gov Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer | — | Completed | — | — | — |
NCT02187991CT.gov Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer | — | Completed | — | — | — |
NCT02219789CT.gov Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery | — | Completed | — | — | — |
NCT01639911CT.gov Phase I Study of MLN8237 and Pazopanib in Patients With Solid Tumors | — | Completed | — | — | — |
NCT01045421CT.gov Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Alisertib (this asset) | Puma Biotechnology, Inc. | P2 | BB · 65 |
| Darolutamide | Vandana Abramson | P2 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Palbociclib | Hoffmann-La Roche | P4 | BB |
| Trastuzumab Duocarmazine | Byondis B.V. | P3 | BB |
| Goserelin | TerSera Therapeutics LLC | P4 | BB |
| Ribociclib | National Cancer Institute (NCI) | P4 | BB |
| Oxaliplatin | Beijing Biostar Pharmaceuticals Co., Ltd. | P4 | BB |
| Eribulin Monomethanesulfonate | Henan Cancer Hospital | P4 | BB |
+42 more in the Breast Cancer cohort
Other indications for Alisertib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Burkitt Lymphoma | — | P2 | BB · 71 |
| Mantle Cell Lymphoma | — | P2 | BB · 69 |
| Follicular Lymphoma | — | P2 | BB · 69 |
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. Alisertib in Breast Cancer. 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/alisertib-breast-cancer
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