CLINICAL TRIALS PROFILE FOR AMCENESTRANT

Clinical Trials for Amcenestrant

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01042379 ↗	I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer	Recruiting	QuantumLeap Healthcare Collaborative	Phase 2	The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
NCT03284957 ↗	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	Recruiting	Sanofi	Phase 1/Phase 2	Primary Objectives: Dose Escalation: - To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib - To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy Safety Run-In: - To confirm the RD of amcenestrant in combination with alpelisib Dose Expansion: - Antitumor activity using objective response rate (ORR) - Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib Secondary Objectives: - Overall safety profile of amcenestrant monotherapy and in combination - Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib - Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS) - Time to first tumor response - Residual ER availability with positron emission tomography (PET) scan [(18)F] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant - Food effect on PK of amcenestrant - Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol
NCT03816839 ↗	Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer	Active, not recruiting	Sanofi	Phase 1	Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer. Secondary Objective: - To characterize the overall safety profile of SAR439859 administered as monotherapy. - To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy. - To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).
NCT04059484 ↗	Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer	Recruiting	Sanofi	Phase 2	Primary Objective: To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms
NCT04191382 ↗	Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer	Terminated	Sanofi	Phase 2	Primary Objective: To determine whether amcenestrant given at 2 different doses improves the antiproliferative activity when compared to letrozole Secondary Objectives: - To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms - To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms - To assess safety in the three treatment arms

Clinical Trial Conditions for Amcenestrant

Condition Name

Condition Name
Intervention	Trials
Breast Cancer	8
HER2-negative Breast Cancer	2
HER2-positive Breast Cancer	1
Angiosarcoma	1

Condition MeSH

Condition MeSH
Intervention	Trials
Breast Neoplasms	8
Hemangiosarcoma	1
Triple Negative Breast Neoplasms	1

Clinical Trial Locations for Amcenestrant

Trials by Country

Trials by Country
Location	Trials
United States	78
Japan	24
Spain	13
Italy	9
Canada	8

Trials by US State

Trials by US State
Location	Trials
Texas	5
California	5
Washington	4
North Carolina	4
New York	4

Clinical Trial Progress for Amcenestrant

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	4
Not yet recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for Amcenestrant

Sponsor Name

Sponsor Name
Sponsor	Trials
Sanofi	8
QuantumLeap Healthcare Collaborative	1
United States Department of Defense	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	8
Other	5
U.S. Fed	1