Breast CancerPhase 1AMEERA-2NCT03816839
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
A Phase 1 study testing Amcenestrant (SAR439859) in people with Breast Cancer, run by Sanofi at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Amcenestrant (SAR439859)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesJapan
- Study dates
- 25 Mar 2019to 26 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Investigational Site Number : 3920002
Chuo-ku, Tokyo, 104-0045
Investigational Site Number : 3920001
Kashiwa-shi, Chiba, 277-8577
Investigational Site Number : 3920003
Nagoya, Aichi-ken, 464-8681
About this study
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)
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).
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Amcenestrant (SAR439859)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amcenestrant (SAR439859)Drug
Pharmaceutical form: Capsules
Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| SAR439859 | Experimental | administered orally once daily or twice daily as monotherapy in fasted or fed state Receives: Drug: Amcenestrant (SAR439859) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
Incidence rate of study treatment-related DLTs at Cycle 1
Measured: Day 1 to Day 28
Secondary outcomes (10)
Safety: Adverse Events (AEs)
Number of adverse events related to study therapy
Measured: Up to 30 days after administration of study treatment
Assessment of Pharmacokinetic parameter of SAR439859: tlag
Lag time, interval between administration time and the sampling time preceding the first concentration above the lower limit of quantification
Measured: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: tmax
First time to reach Cmax
Measured: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: Cmax
Maximum concentration observed
Measured: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h
Area under the plasma concentration versus time curve over the dosing interval (24 hours, 10 hours or 12 hours)
Measured: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: Ctrough
Plasma concentration observed just before treatment administration during repeated dosing
Measured: Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2
Assessment of antitumor activity: Objective response rate (ORR)
Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: 64 weeks
Assessment of antitumor activity: Clinical benefit rate (CBR)
Clinical benefit rate is (CR [complete response] +PR [partial response] +SD [stable disease] ≥24 weeks) as per RECIST 1.1
Measured: 64 weeks
Assessment of antitumor activity: Duration of response
Response duration defined as the time from initial response to the first documented tumor progression
Measured: 64 weeks
Assessment of antitumor activity: Non-progression rate
Non-progression rate at 24 weeks (percentage of participants without progression at 24 weeks)
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start25 Mar 2019
- Primary completion27 Oct 2020
- Study completion26 Dec 2024
Why it stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816839
- Sponsor's protocol ID
- TED15954
- Other IDs
- U1111-1217-2758
- Acronym
- AMEERA-2
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2019
- Last updated
- 7 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Tamura K, Mukohara T, Yonemori K, Kawabata Y, Nicolas X, Tanaka T, Iwata H. Phase 1 study of oral selective estrogen receptor degrader (SERD) amcenestrant (SAR439859), in Japanese women with ER-positive and HER2-negative advanced breast cancer (AMEERA-2). Breast Cancer. 2023 May;30(3):506-517. doi: 10.1007/s12282-023-01443-8. Epub 2023 Mar 29.
PubMed 36977973
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03816839
- Acronym / sponsor ID
- AMEERA-2 / TED15954
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to prematurely stop the study, not linked to any safety concern.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR439859 | Experimental | Drug: Amcenestrant (SAR439859)administered orally once daily or twice daily as monotherapy in fasted or fed state |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amcenestrant (SAR439859)Pharmaceutical form: Capsules Route of administration: Oral | Drug | SAR439859 |
Primary outcome
Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
Time frame: Day 1 to Day 28
Incidence rate of study treatment-related DLTs at Cycle 1
10 secondary outcomes
Safety: Adverse Events (AEs)
Time frame: Up to 30 days after administration of study treatment
Assessment of Pharmacokinetic parameter of SAR439859: tlag
Time frame: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: tmax
Time frame: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: Cmax
Time frame: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h
Time frame: Day 1 and Day 22 of Cycle 1 (28 days)
Assessment of Pharmacokinetic parameter of SAR439859: Ctrough
Time frame: Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2
Assessment of antitumor activity: Objective response rate (ORR)
Time frame: 64 weeks
Assessment of antitumor activity: Clinical benefit rate (CBR)
Time frame: 64 weeks
Assessment of antitumor activity: Duration of response
Time frame: 64 weeks
Assessment of antitumor activity: Non-progression rate
Time frame: 64 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision to prematurely stop the study, not linked to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2025.
- Results publication: PubMed 36977973Tamura K, Mukohara T, Yonemori K, Kawabata Y, Nicolas X, Tanaka T, Iwata H. Phase 1 study of oral selective estrogen receptor degrader (SERD) amcenestrant (SAR439859), in Japanese women with ER-positive and HER2-negative advanced breast cancer (AMEERA-2). Breast Cancer. 2023 May;30(3):506-517. doi: 10.1007/s12282-023-01443-8. Epub 2023 Mar 29.
- TED15954 Plain language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amcenestrant (SAR439859) in people with Breast Cancer, run by Sanofi at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to prematurely stop the study, not linked to any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs) (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03816839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2025.