Floatz Rating
CCC55/100
Confidence
Indicative
Sponsor
M.D. Anderson Cancer Center
Modality
monoclonal_antibody
Development Phase
Phase 2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
49High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07407920CT.gov Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial | — | Active Not Recruiting | — | — | — |
NCT06253871CT.gov A Phase 1/1b Study of IAM1363 in HER2 Cancers | — | Recruiting | — | — | — |
NCT05020860CT.gov Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer | — | Recruiting | — | — | — |
NCT04789096CT.gov Tucatinib Together With Pembrolizumab and Trastuzumab | — | Terminated | — | — | — |
NCT04512261CT.gov TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases | — | Withdrawn | — | — | — |
NCT05081609CT.gov A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies | — | Active Not Recruiting | — | — | — |
NCT04660929CT.gov CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors | — | Unknown | — | — | — |
NCT04585750CT.gov The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | — | Recruiting | — | — | — |
NCT03632941CT.gov A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer | — | Terminated | — | — | — |
NCT03841110CT.gov FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors | — | Completed | — | — | — |
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NCT03747120CT.gov Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP] | — | Active Not Recruiting | — | — | — |
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.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · HER2 Positive Breast Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Pembrolizumab (this asset) | M.D. Anderson Cancer Center | P2 | CCC · 55 |
| 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 Pembrolizumab
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Her2-Receptor Negative Breast Cancer | — | P2 | BBB · 72 |
| Estrogen-Receptor Negative Breast Cancer | — | P2 | BB · 71 |
| Progesterone-Receptor Negative Breast Cancer | — | P2 | BB · 71 |
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. Pembrolizumab 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/pembrolizumab-her2-positive-breast-carcinoma
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