Floatz Rating
CC46/100
Confidence
Indicative
Sponsor
Sanofi
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.
40High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05128773CT.gov Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity | — | Terminated | — | — | — |
NCT04940026CT.gov Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women | — | Completed | — | — | — |
NCT04478266CT.gov Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer | — | Terminated | — | — | — |
NCT04191382CT.gov Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer | — | Terminated | — | — | — |
NCT04059484CT.gov Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer | — | Terminated | — | — | — |
NCT03816839CT.gov Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2) | — | Terminated | — | — | — |
NCT03284957CT.gov Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer | — | Terminated | — | — | — |
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 |
|---|---|---|---|
| Amcenestrant (this asset) | Sanofi | P3 | CC · 46 |
| 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 Amcenestrant
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Neoplasm | — | P2 | C · 39 |
| Angiosarcoma | — | P2 | C · 39 |
| Triple-Negative Breast Carcinoma | — | P2 | C · 39 |
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. Amcenestrant 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/amcenestrant-breast-cancer
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