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

Terminated · Phase 3 · NCT04478266

Conditions: Breast Cancer

At a glance

Research payments reported, 2025
$8,677
U.S. investigators named
2
Sites paid
2
Planned or actual enrollment
1,068

About the trial

Sponsor
Sanofi
Tested
Amcenestrant-matching placebo (drug), SAR439859 (drug), Palbociclib (drug), Letrozole (drug), Goserelin (drug), Letrozole-matching placebo (drug)
Dates
Started 2020-10-14; completion 2023-05-26
Results posted
Yes

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: * To compare the overall survival in both treatment arms. * To evaluate the objective response rate in both treatment arms. * To evaluate the duration of response in both treatment arms. * To evaluate the clinical benefit rate in both treatment arms. * To e…

From ClinicalTrials.gov, last updated 2025-09-11. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $8,677 in research payments for this study in 2025 (3 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.