Amcenestrant (SAR439859) Clinical Trials

Size	Price	Qty
5mg	USD 390
25mg	USD 1,170

Clinical Trials

Multiple Phase 1, Phase 2, and Phase 3 clinical trials, sponsored primarily by Sanofi and QuantumLeap Healthcare Collaborative, have evaluated amcenestrant (SAR439859) as a monotherapy and in combination regimens. The clinical program targeted angiosarcoma, healthy volunteers, individuals with abnormal hepatic function, and various manifestations of breast cancer, including early-stage, locally advanced, metastatic, triple-negative, HER2-positive, and HER2-negative neoplasms. Across these investigations, study recruitment statuses range from recruiting and active, not recruiting to completed and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01042379	RECRUITING	Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer	QuantumLeap Healthcare Collaborative	2010-03-01	PHASE2
NCT03284957	TERMINATED	Breast Cancer	Sanofi	2017-09-20	PHASE1; PHASE2
NCT05128773	TERMINATED	Breast Cancer	Sanofi	2022-02-17	PHASE3
NCT04478266	TERMINATED	Breast Cancer	Sanofi	2020-10-14	PHASE3
NCT05126329	TERMINATED	Hepatic Function Abnormal	Sanofi	2021-11-15	PHASE1
NCT04059484	TERMINATED	Breast Cancer Metastatic	Sanofi	2019-10-22	PHASE2
NCT04940026	COMPLETED	Breast Cancer; Healthy Volunteers	Sanofi	2021-06-15	PHASE1
NCT04191382	TERMINATED	Breast Cancer	Sanofi	2020-02-04	PHASE2
NCT03816839	TERMINATED	Breast Cancer	Sanofi	2019-03-25	PHASE1
NCT03816839	Active not recruiting	Breast Cancer	Sanofi	2019-03-25	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the Amcenestrant (SAR439859) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amcenestrant is an orally available nonsteroidal selective estrogen receptor degrader that potently binds to estrogen receptor alpha with an EC50 of 0.2 nM for receptor degradation, thereby disrupting downstream estrogen-mediated transcriptional activation and driving degradation of the receptor target. By inhibiting estrogen-dependent proliferative signaling and suppressing cancer cell viability, Amcenestrant impairs tumor growth, demonstrating direct clinical relevance in trials evaluating advanced and metastatic breast cancers.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).