Floatz Rating
B58/100
Confidence
Indicative
Sponsor
MedSIR
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
58High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07494448CT.gov Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07193394CT.gov Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT06686394CT.gov Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) | — | Recruiting | — | — | — |
NCT06439693CT.gov The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT06157892CT.gov A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors | — | Recruiting | — | — | — |
NCT06239467CT.gov First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT05458674CT.gov Tucatinib+Trastuzumab+Eribulin in HER2+ MBC | — | Recruiting | — | — | — |
NCT06162559CT.gov Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study | — | Recruiting | — | — | — |
NCT05748834CT.gov Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT05892068CT.gov A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain | — | Active Not Recruiting | — | — | — |
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NCT05323955CT.gov Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib | — | Active Not Recruiting | — | — | — |
NCT04789096CT.gov Tucatinib Together With Pembrolizumab and Trastuzumab | — | Terminated | — | — | — |
NCT05868226CT.gov PRE-I-SPY Phase I/Ib Oncology Platform Program | — | Recruiting | — | — | — |
NCT04512261CT.gov TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases | — | Withdrawn | — | — | — |
NCT05227131CT.gov Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer | — | Withdrawn | — | — | — |
NCT05319873CT.gov Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT05041842CT.gov Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT04896320CT.gov Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer. | — | Withdrawn | — | — | — |
NCT04721977CT.gov A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) | — | Active Not Recruiting | — | — | — |
NCT04457596CT.gov T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial | — | Active Not Recruiting | — | — | — |
NCT04538742CT.gov A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03846583CT.gov Tucatinib + Abemaciclib + Herceptin for HER2+ MBC | — | Withdrawn | — | — | — |
NCT03501979CT.gov Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD | — | Terminated | — | — | — |
NCT03054363CT.gov Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer | — | Completed | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Tucatinib (this asset) | MedSIR | P3 | B · 58 |
| 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 Tucatinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P3 | BB · 67 |
| Metastatic Neoplasm | — | P2 | B · 63 |
| Invasive Breast Carcinoma | — | P3 | B · 63 |
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. Tucatinib in Breast Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 11, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/tucatinib-breast-cancer
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