Floatz Rating
B58/100
Confidence
Indicative
Sponsor
UNC Lineberger Comprehensive Cancer Center
Modality
antibody_drug_conjugate
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 |
|---|---|---|---|---|---|
NCT07069595CT.gov PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease | — | Recruiting | — | — | — |
NCT07205822CT.gov A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer | — | Recruiting | — | — | — |
NCT07582887CT.gov Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response | — | Recruiting | — | — | — |
NCT06533826CT.gov TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd | — | Recruiting | — | — | — |
NCT06508216CT.gov A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer | — | Recruiting | — | — | — |
NCT06176261CT.gov DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs | — | Recruiting | — | — | — |
NCT06103864CT.gov A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer | — | Recruiting | — | — | — |
NCT06112379CT.gov A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT05866432CT.gov Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases | — | Recruiting | — | — | — |
NCT06504719CT.gov Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan | — | Completed | — | — | — |
Show 6 more trialsShow fewer
NCT05629585CT.gov A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) | — | Active Not Recruiting | — | — | — |
NCT05374512CT.gov A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02) | — | Active Not Recruiting | — | — | — |
NCT05104866CT.gov A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) | — | Active Not Recruiting | — | — | — |
NCT04644068CT.gov Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies | — | Active Not Recruiting | — | — | — |
NCT02448420CT.gov Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic 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 |
|---|---|---|---|
| Datopotamab Deruxtecan (this asset) | UNC Lineberger Comprehensive Cancer Center | 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 Datopotamab Deruxtecan
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Non-Small Cell Lung Carcinoma | — | P3 | B · 63 |
| Stomatitis | — | P4 | B · 61 |
| Biliary Tract Cancer | — | P2 | B · 60 |
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. Datopotamab Deruxtecan 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/datopotamab-deruxtecan-breast-cancer
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