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Showing 1–5 of 5 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Amcenestrant Clear all
Terminated Phase 3 Interventional Results available

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

NCT04478266
View directory record Official record
Conditions
Breast Cancer
Interventions
Amcenestrant-matching placebo, SAR439859, Palbociclib, Letrozole, Goserelin, Letrozole-matching placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
1,068 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
45
States / cities
Daphne, Alabama • Glendale, Arizona • Tucson, Arizona + 40 more
Source: ClinicalTrials.gov public record
Updated Sep 10, 2025 · Synced Sep 1, 2026, 10:17 PM EDT
Terminated Phase 2 Interventional Results available

Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

NCT04191382
View directory record Official record
Conditions
Breast Cancer
Interventions
Amcenestrant (SAR439859), Letrozole
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older · Female only
Enrollment
105 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
6
States / cities
Tucson, Arizona • Los Angeles, California • Fort Wayne, Indiana + 3 more
Source: ClinicalTrials.gov public record
Updated Sep 17, 2025 · Synced Sep 1, 2026, 10:17 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

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

NCT03284957
View directory record Official record
Conditions
Breast Cancer
Interventions
Amcenestrant, Palbociclib, Alpelisib, Everolimus, Abemaciclib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older · Female only
Enrollment
136 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
4
States / cities
Aurora, Colorado • Boston, Massachusetts • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Nov 23, 2025 · Synced Sep 1, 2026, 10:17 PM EDT
Terminated Phase 2 Interventional Results available

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

NCT04059484
View directory record Official record
Conditions
Breast Cancer Metastatic
Interventions
Amcenestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane, Tamoxifen
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
367 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
14
States / cities
Birmingham, Alabama • Bakersfield, California • Santa Monica, California + 11 more
Source: ClinicalTrials.gov public record
Updated Feb 23, 2026 · Synced Sep 1, 2026, 10:17 PM EDT
Recruiting Phase 2 Interventional

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

NCT01042379
View directory record Official record
Conditions
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
Interventions
Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab, T-DM1 and Pertuzumab, Pertuzumab and Trastuzumab, Ganetespib, ABT-888, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, Amcenestrant + Abemaciclib, Amcenestrant + Letrozole, ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, Datopotamab deruxtecan, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel, GSK 5733584, GSK 5733584 + Dostarlimab, Ivonescimab (20mg/kg Q3W)
Drug
Lead sponsor
QuantumLeap Healthcare Collaborative
Other
Eligibility
18 Years and older
Enrollment
5,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2031
U.S. locations
42
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Tucson, Arizona + 36 more
Source: ClinicalTrials.gov public record
Updated May 5, 2026 · Synced Sep 1, 2026, 10:17 PM EDT