Status:
TERMINATED
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
1068 Patients enrolled
Trial Details
Trial ID
NCT04478266
Start Date
October 14 2020
End Date
May 26 2023
Last Update
September 11 2025
Active Locations (249)
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1
Investigational Site Number :8400075
Daphne, Alabama, United States, 36526
2
Investigational Site Number :8400083
Glendale, Arizona, United States, 85308
3
Investigational Site Number :8400066
Tucson, Arizona, United States, 85712
4
Investigational Site Number :8400038
Fullerton, California, United States, 92835