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Amcenestrant

Generic Name
Amcenestrant
Clinical Trials
Related News

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

Phase 3
Terminated
Conditions
Breast Cancer
Interventions
Drug: Tamoxifen-matching placebo
Drug: Amcenestrant-matching placebo
First Posted Date
2021-11-22
Last Posted Date
2023-06-22
Lead Sponsor
Sanofi
Target Recruit Count
3
Registration Number
NCT05128773
Locations
🇨🇳

Investigational Site Number :1561599, Haikou, China

🇨🇱

Investigational Site Number :1521622, Santiago, Reg Metropolitana De Santiago, Chile

Pharmacokinetics of Amcenestrant in Female Hepatic Impaired Participants as Compared to Participants With Normal Hepatic Function

Phase 1
Terminated
Conditions
Hepatic Function Abnormal
Interventions
First Posted Date
2021-11-19
Last Posted Date
2022-09-14
Lead Sponsor
Sanofi
Target Recruit Count
13
Registration Number
NCT05126329
Locations
🇩🇪

Investigational Site Number :2760001, Kiel, Germany

🇰🇷

Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of

🇰🇷

Investigational site number :4100002, Cheongju-si, Korea, Republic of

Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women

Phase 1
Completed
Conditions
Breast Cancer
Healthy Volunteers
Interventions
Drug: [14C]-SAR439859 microtracer
Drug: [14C]-SAR439859
First Posted Date
2021-06-25
Last Posted Date
2022-04-25
Lead Sponsor
Sanofi
Target Recruit Count
6
Registration Number
NCT04940026
Locations
🇬🇧

Investigational Site Number 8260001, Nottingham, United Kingdom

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Phase 3
Terminated
Conditions
Breast Cancer
Interventions
Drug: Amcenestrant-matching placebo
Drug: Letrozole-matching placebo
First Posted Date
2020-07-20
Last Posted Date
2023-12-08
Lead Sponsor
Sanofi
Target Recruit Count
1068
Registration Number
NCT04478266
Locations
🇺🇸

Investigational Site Number :8400029, Santa Monica, California, United States

🇺🇸

Investigational Site Number :8400038, Fullerton, California, United States

🇺🇸

Investigational Site Number :8400013, Westwood, Kansas, United States

and more 246 locations

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

First Posted Date
2019-08-16
Last Posted Date
2025-01-27
Lead Sponsor
Sanofi
Target Recruit Count
367
Registration Number
NCT04059484
Locations
🇺🇦

Investigational Site Number : 8040001, Kryvyi Rih, Ukraine

🇬🇷

Investigational Site Number : 3000004, Thessaloniki, Greece

🇧🇷

Hospital de Clinicas de Porto Alegre - HCPA Site Number : 0760001, Porto Alegre, Rio Grande Do Sul, Brazil

and more 106 locations

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

First Posted Date
2017-09-15
Last Posted Date
2024-12-06
Lead Sponsor
Sanofi
Target Recruit Count
136
Registration Number
NCT03284957
Locations
🇨🇦

Investigational Site Number : 1240003, Vancouver, British Columbia, Canada

🇨🇦

Investigational Site Number : 1240002, Toronto, Ontario, Canada

🇨🇿

Investigational Site Number : 2030002, Brno, Czechia

and more 22 locations

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Phase 2
Recruiting
Conditions
HER2-negative Breast Cancer
Hormone Receptor Positive Tumor
Angiosarcoma
TNBC - Triple-Negative Breast Cancer
Breast Neoplasms
Breast Tumors
HER2-positive Breast Cancer
Hormone Receptor Negative Tumor
Breast Cancer
Early-stage Breast Cancer
Interventions
Drug: Standard Therapy
Drug: AMG 386 with or without Trastuzumab
Drug: AMG 479 (Ganitumab) plus Metformin
Drug: SYD985 ([vic-]trastuzumab duocarmazine)
Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab
Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab
Drug: Datopotamab deruxtecan + Durvalumab
Drug: Rilvegostomig + TDXd
Drug: AMG 386 and Trastuzumab
First Posted Date
2010-01-05
Last Posted Date
2024-10-22
Lead Sponsor
QuantumLeap Healthcare Collaborative
Target Recruit Count
5000
Registration Number
NCT01042379
Locations
🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

University of Texas, Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

University of Kansas, Westwood, Kansas, United States

and more 33 locations
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