Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Key facts
- Who runs it
- Sanofi
- Where
- Japan3 sites in 1 countryChoose a country to see its sites
- Trial code
- NCT03816839
- U1111-1217-2758
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 10 people enrolled
- Started
- 25 Mar 2019
- Ended
- 26 Dec 2024
- Type of study
- Interventional
- Treatments tested
- Amcenestrant (SAR439859)
- Record updated
- 7 July 2025
- Why it stopped
- Sponsor decision to prematurely stop the study, not linked to any safety concern.
Who can take part
- Age
- 20 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Significant concomitant illness that would adversely affect participation in the study
- Major surgery within 4 weeks prior to first study treatment administration
- Treatment with strong and moderate cytochrome P450 3A inhibitors/inducers
- 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)
- 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
- Patients with known endometrial disorders, uterine bleeding or ovarian cysts
- 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
- Eastern Cooperative Oncology Group Performance Status (ECOG) ≥2
- Patients with a life expectancy less than 3 months
- Patient not suitable for participation, whatever the reason
- Inadequate hematological function
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Primary Objective:
Read full original descriptionShow less
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).
The group in the trial
- SAR439859Treatment being tested
administered orally once daily or twice daily as monotherapy in fasted or fed state
Treatment: Amcenestrant (SAR439859)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1 Study for the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy in Japanese Postmenopausal Women With Estrogen Receptor-Positive And Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer (AMEERA-2)
- Record updated
- 7 July 2025