Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)

Inclusion criteria :

* Participants must be postmenopausal women.
* Breast adenocarcinoma patients with locally advanced not amenable to radiation or surgery, inoperable and/or metastatic disease.
* Either the primary or any metastatic site must be positive for estrogen receptor (ER) (\>1% staining by immunohistochemistry).
* Either the primary tumor or any metastatic site must be human epidermal growth factor receptor 2 non-overexpressing.
* Patients with at least 6 months of prior endocrine therapy.

Exclusion criteria:

* Eastern Cooperative Oncology Group Performance Status (ECOG) ≥2.
* Significant concomitant illness that would adversely affect participation in the study.
* Patients with a life expectancy less than 3 months.
* Patient not suitable for participation, whatever the reason.
* Major surgery within 4 weeks prior to first study treatment administration.
* Treatment with strong and moderate cytochrome P450 3A inhibitors/inducers.
* Patients with known endometrial disorders, uterine bleeding or ovarian cysts.
* Treatment with anticancer less than 2 weeks before first study treatment.
* Prior treatment with selective estrogen receptor down (SERD)-regulator (except fulvestrant for which a washout of at least 6 weeks is required).
* Inadequate hematological function.
* Inadequate renal function with serum creatinine ≥1.5 x upper limit of normal (ULN).
* Liver function: aspartate aminotransferase \>3 x ULN, or alanine aminotransferase \>3 x ULN. Total bilirubin \>1.5 x ULN.
* Non-resolution of any prior treatment related toxicity to \<Grade 2, except for alopecia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.