Irinotecan
Her2-Receptor Negative Breast Cancer
Explore 186 assets in Her2-Receptor Negative Breast Cancer →Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
GI Innovation, Inc.
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
67High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05824975CT.gov A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08) | — | Recruiting | — | — | — |
NCT05594095CT.gov SNF Platform Study of HR+/ HER2-advanced Breast Cancer | — | Recruiting | — | — | — |
NCT05398861CT.gov Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT02806817CT.gov ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism | — | Completed | — | — | — |
NCT02248571CT.gov Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab | — | Completed | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
NCT00785291CT.gov Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer | — | Completed | — | — | — |
NCT00733408CT.gov Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer | — | Completed | — | — | — |
NCT00618657CT.gov Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting | — | Completed | — | — | — |
NCT00031681CT.gov 7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) | — | Completed | — | — | — |
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-Receptor Negative Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Irinotecan (this asset) | GI Innovation, Inc. | Approved | BB · 66 |
| Palbociclib | Helwan University | P2 | BBB |
| Exemestane | National Cancer Institute (NCI) | P4 | BBB |
| Pembrolizumab | UNC Lineberger Comprehensive Cancer Center | P2 | BBB |
| Atezolizumab | TransThera Sciences (Nanjing), Inc. | P2 | BB |
| Capecitabine | Kristina A. Fanucci | P4 | BB |
| Docetaxel | Jiangsu Hansoh Pharmaceutical Co., Ltd. | P2/3 | BB |
| Palazestrant | Olema Pharmaceuticals, Inc. | P3 | BB |
| Durvalumab | National Cancer Institute (NCI) | P3 | BB |
+42 more in the Her2-Receptor Negative Breast Cancer cohort
Other indications for Irinotecan
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Rectal Cancer | — | P4 | BBB · 78 |
| Exocrine Pancreatic Carcinoma | — | P2/3 | BBB · 78 |
| Colon Adenocarcinoma | — | P3 | BBB · 76 |
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. Irinotecan in Her2-Receptor Negative 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/irinotecan-her2-receptor-negative-breast-cancer
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