Amcenestrant clinical trials
Also written SAR439859.
How each study uses amcenestrant is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
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Approvals
The first approval found in each region, with its record
- United States
- Not in FDA's approval records
- European Union
- Not in EMA's list of EU-wide authorisations
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
9 studies that test it; most in 2019 (2)
| Year | Studies |
|---|---|
| 2010 | 1 |
| 2017 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 8 · Other 1
Often tested with
Tested in the same studies.
Trastuzumab (1) · Ganitumab (1) · Ado-Trastuzumab Emtansine (1) · Pertuzumab (1) · STA 9090 (1) · Veliparib (1) · Neratinib (1) · Pexidartinib (1)
Studies
Open first, then newest update. How each study uses amcenestrant is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 9
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast CancerRecruitingPhase 2QuantumLeap Healthcare CollaborativeNCT01042379Written as Amcenestrant
- Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast CancerTerminatedPhase 2SanofiNCT04059484Written as Amcenestrant
- 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 CancerTerminatedPhase 1/2SanofiNCT03284957Written as Amcenestrant
- Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal WomenCompletedPhase 1SanofiNCT04940026Written as amcenestrant
- Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic FunctionTerminatedPhase 1SanofiNCT05126329Written as amcenestrant
- Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast CancerTerminatedPhase 2SanofiNCT04191382Written as Amcenestrant (SAR439859)
- 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 ToxicityTerminatedPhase 3SanofiNCT05128773Written as Amcenestrant
- Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast CancerTerminatedPhase 3SanofiNCT04478266Written as SAR439859
- Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)TerminatedPhase 1SanofiNCT03816839Written as Amcenestrant (SAR439859)
Codes
What other systems call amcenestrant · ClinicalTrials.gg INT018008
- UNII (FDA) TBF1NHY02OAMCENESTRANTOne source FDA
- NCI Thesaurus C174915AmcenestrantOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| UNII (FDA) | TBF1NHY02O | AMCENESTRANT | One source FDA |
| NCI Thesaurus | C174915 | Amcenestrant | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.