Status:
TERMINATED
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Lead Sponsor:
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE1
Brief Summary
Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanes...
Detailed Description
The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days) of s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03816839
Start Date
March 25 2019
End Date
December 26 2024
Last Update
July 7 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number : 3920003
Nagoya, Aichi-ken, Japan, 464-8681
2
Investigational Site Number : 3920001
Kashiwa-shi, Chiba, Japan, 277-8577
3
Investigational Site Number : 3920002
Chuo-ku, Tokyo, Japan, 104-0045