Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Amcenestrant-matching placebo; SAR439859; Palbociclib; Letrozole; Goserelin; Letrozole-matching placebo
Intervention description: Pharmaceutical form: Tablets Route of Administration: Oral; Pharmaceutical form: Tablets Route of Administration: Oral; Pharmaceutical form: Capsules/Tablets Route of Administration: Oral; Pharmaceutical form: Capsules Route of Administration: Orally; Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous; Pharmaceutical form: Capsules Route of Administration: Orally
Intervention MeSH terms: Letrozole; Palbociclib; Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1068.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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 childbearing 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.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.