Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
- Conditions
- Breast Cancer
- Interventions
- Drug: Amcenestrant (SAR439859)
- Registration Number
- NCT03816839
- Lead Sponsor
- Sanofi
- 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 Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer.
Secondary Objective:
* To characterize the overall safety profile of SAR439859 administered as monotherapy.
* To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy.
* To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).
- 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 study treatment, and an End of Treatment (EOT) visit at least 30 days (or until the participant receives another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, or upon participant's request.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAR439859 Amcenestrant (SAR439859) administered orally once daily or twice daily as monotherapy in fasted or fed state
- Primary Outcome Measures
Name Time Method Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs) Day 1 to Day 28 Incidence rate of study treatment-related DLTs at Cycle 1
- Secondary Outcome Measures
Name Time Method Safety: Adverse Events (AEs) Up to 30 days after administration of study treatment Number of adverse events related to study therapy
Assessment of Pharmacokinetic parameter of SAR439859: tlag Day 1 and Day 22 of Cycle 1 (28 days) Lag time, interval between administration time and the sampling time preceding the first concentration above the lower limit of quantification
Assessment of Pharmacokinetic parameter of SAR439859: Ctrough Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2 Plasma concentration observed just before treatment administration during repeated dosing
Assessment of Pharmacokinetic parameter of SAR439859: Cmax Day 1 and Day 22 of Cycle 1 (28 days) Maximum concentration observed
Assessment of antitumor activity: Duration of response 64 weeks Response duration defined as the time from initial response to the first documented tumor progression
Assessment of Pharmacokinetic parameter of SAR439859: tmax Day 1 and Day 22 of Cycle 1 (28 days) First time to reach Cmax
Assessment of antitumor activity: Clinical benefit rate (CBR) 64 weeks Clinical benefit rate is (CR \[complete response\] +PR \[partial response\] +SD \[stable disease\] ≥24 weeks) as per RECIST 1.1
Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h Day 1 and Day 22 of Cycle 1 (28 days) Area under the plasma concentration versus time curve over the dosing interval (24 hours, 10 hours or 12 hours)
Assessment of antitumor activity: Objective response rate (ORR) 64 weeks Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Assessment of antitumor activity: Non-progression rate 64 weeks Non-progression rate at 24 weeks (percentage of participants without progression at 24 weeks)
Trial Locations
- Locations (3)
Investigational Site Number : 3920003
🇯🇵Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920002
🇯🇵Chuo-ku, Tokyo, Japan
Investigational Site Number : 3920001
🇯🇵Kashiwa-shi, Chiba, Japan