To determine whether amcenestrant per os improves progression free survival (PFS) when
compared with a endocrine monotherapy of the choice of the physician, in participants with
metastatic or locally advanced breast cancer
To compare the overall survival in the 2 treatment arms
To assess the objective response rate in the 2 treatment arms
To evaluate the disease control rate in the 2 treatment arms
To evaluate the clinical benefit rate in the 2 treatment arms
To evaluate the duration of response in the 2 treatment arms
To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in
the 2 treatment arms
To evaluate the pharmacokinetics of amcenestrant as single agent
To evaluate health related quality of life in the 2 treatment arms
To compare the overall safety profile in the 2 treatment arms
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 receive another anticancer therapy, whichever is earlier) following the
last administration of study treatment. Study treatment may continue until precluded by
unacceptable toxicity, disease progression, death or upon participant's request.
An extension of recruitment for Chinese participants is planned in this study: After
completion of randomization in the global part of the study, randomization will continue in
China until approximately 90 Chinese participants are randomized.
Metastatic Breast Cancer,
Stage IV Breast Cancer,
Breast Cancer Metastatic
Endocrine monotherapy as per physician choice,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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