Clinical Trials Using SERD SAR439859

Clinical trials are research studies that involve people. The clinical trials on this list are studying SERD SAR439859. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-3 of 3
  • Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

    Primary Objectives: Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib) - To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in combination with palbociclib (Part C) Dose Expansion: Part B (SAR439859 monotherapy) - To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy Dose Expansion: Part D (combination of SAR439859 with palbociclib) - Overall safety profile of SAR439859 in combination with palbociclib Midazolam Drug-Drug Interaction Sub-Study: Part E - To assess the effect of SAR439859 on CYP3A enzyme activity using midazolam as a probe Secondary Objectives: - Overall safety profile of SAR439859 as monotherapy (Parts A, B, E), and in combination with palbociclib (Parts C, D) - Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A, B, E), and of SAR439859 in combination with palbociclib (Parts C, D), and of palbociclib in combination with SAR439859 (Parts C, D) - Antitumor activity of SAR439859 as monotherapy (Part A and E), and in combination with palbociclib (Part C and D) as well as the Clinical Benefit Rate (CBR: Complete Response [CR], Partial Response [PR] and Stable Disease [SD] ≥24 weeks) in Parts A, B, C, D and E - ORR and CBR (CR, PR and SD ≥24 weeks) in Parts B, D and E according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment - Time to first tumor response (CR or PR) in Parts B and D - Residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A) - To assess potential induction / inhibition effect of SAR439859 on CYP3A (Part A, B, E)
    Location: 7 locations

  • Phase 2 Study of SAR439859 Versus Physician's Choice in Premenopausal and Postmenopausal Locally Advanced or Metastatic ER-positive Breast Cancer

    Primary Objective: To determine whether SAR439859 per os improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer. Secondary Objectives: - To compare the objective response rate in the 2 treatment arms. - To evaluate the disease control rate in the 2 treatment arms. - To evaluate the clinical benefit rate in the 2 treatment arms. - To evaluate the duration of response in the 2 treatment arms. - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms. - To evaluate the overall survival in the 2 treatment arms. - To evaluate the pharmacokinetics of SAR439859 as single agent. - To evaluate health related quality of life in the 2 treatment arms. - To evaluate the overall safety profile in the 2 treatment arms.
    Location: 4 locations

  • Study of SAR439859 Versus Letrozole in ER Positive, HER2 Negative Pre-operative Post-menopausal Primary Breast Cancer

    Primary Objective: To determine whether SAR439859 given at 2 different doses improves the antiproliferative activity when compared to letrozole Secondary Objectives: - To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms - To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms - To assess safety in the three treatment arms
    Location: 2 locations