Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
- Trial number:
-
NCT04478266
- Trial phase:
- 3
- Study type:
- Targeted therapy, Hormonal therapy
- Overall status:
- Active, not recruiting
Study start date
Scientific title
Summary
Inclusion criteria :
Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatmentConfirmed 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 metastasesPrior 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study design
Conditions
Other study ID numbers
Choose trial site (497)

