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

Official Title

A Randomized, Multicentre, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Summary:

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

Trial Description

Primary Outcome:

  • Progression-free survival
Secondary Outcome:
  • Overall Survival
  • Objective Response Rate
  • Duration of Response
  • Clinical Benefit Rate
  • PK parameter: Plasma concentrations
  • Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
  • Time to First Chemotherapy
  • Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
  • Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
  • Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR45) questionnaire
  • Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR23) questionnaire
  • Progression-free survival on next line of therapy (PFS2)
Study duration per participant is approximately 59 months, which includes a 33- month treatment period

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society