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

NCT04478266 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1068

Last updated 2025-09-11

Study results available
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Summary

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 evaluate progression-free survival on next line of therapy.
* To evaluate the pharmacokinetics of amcenestrant, and palbociclib.
* To evaluate health-related quality of life in both treatment arms.
* To evaluate the time to first chemotherapy in both treatment arms.
* To evaluate safety in both treatment arms.

Conditions

Interventions

DRUG

Amcenestrant-matching placebo

Pharmaceutical form: Tablets Route of Administration: Oral

DRUG

SAR439859

Pharmaceutical form: Tablets Route of Administration: Oral

DRUG

Palbociclib

Pharmaceutical form: Capsules/Tablets Route of Administration: Oral

DRUG

Letrozole

Pharmaceutical form: Capsules Route of Administration: Orally

DRUG

Goserelin

Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous

DRUG

Letrozole-matching placebo

Pharmaceutical form: Capsules Route of Administration: Orally

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2022-06-28
Completion
2023-05-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • Finland
  • France
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478266 on ClinicalTrials.gov