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

NCT03816839 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-07

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Amcenestrant (SAR439859)

Pharmaceutical form: Capsules Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2020-10-27
Completion
2024-12-26

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816839 on ClinicalTrials.gov