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

Trial Status: Active

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, 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

Inclusion Criteria

  • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • No prior systemic treatment for loco-regional recurrent or metastatic disease
  • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants should be willing to provide tumor tissue
  • Capable of giving informed consent

Exclusion Criteria

  • Known active brain metastases
  • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
  • Inadequate organ and marrow function
  • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
  • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
  • Male participants who disagree to follow contraception
  • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
  • Participants with significant concomitant illness

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Sarah Rosales
Phone: 310-794-7686
San Francisco
University of California San Francisco
Status: APPROVED
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Colorado

Aurora
University of Colorado Hospital
Status: APPROVED
Contact: Robyn Swing
Phone: 720-848-0607

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: IN_REVIEW

Kansas

Kansas City
University of Kansas Cancer Center
Status: IN_REVIEW

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: APPROVED

Study duration per participant is approximately 64 months, which includes a 33- month

treatment period

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Sanofi Aventis

  • Primary ID EFC15935
  • Secondary IDs NCI-2020-07111, 2020-001824-33, U1111-1233-0486
  • Clinicaltrials.gov ID NCT04478266