Trial · NCT03284957
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
NCT03284957, Phase 1, Phase 2, Terminated, Sanofi; results first posted 2025-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer. Trials, record NCT03284957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03284957
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
- NCT number
- NCT03284957
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 136 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Breast Cancer
- Interventions
- Amcenestrant, Palbociclib, Alpelisib, Everolimus, Abemaciclib
- First posted
- 2017-09-15
- Last updated
- 2025-11-24
- Other registries' IDs
- eudract:2017-000690-36
- Results first posted
- 2025-11-24
- Limitations and caveats
- Sponsor decision to prematurely stop the study, it was not linked to any safety concern.
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 to Cycle 1 Day 28 (cycle duration=28 days) | DLTs: any treatment-emergent adverse event(TEAE) related to study treatment per National Cancer Institute Common Terminology Criteria for AE scale version (v) 4.03:Grade(G)≥3 nonhematological toxicity except:G3 nausea/vomiting resolved to G≤1 in 48 hours(h),G3 diarrhea with therapy and lasting\<48h,G3 hyperglycemia resolved to G≤1 in 48h(Part H);G≥3 hematological toxicity except:G3 anemia,G4 neutropenia\<7days(d),G3 neutropenia without fever/infection,G3 thrombocytopenia without bleeding;elevated total serum bilirubin(BL)\>2xupper limit of normal(except Part F),Part F:G3 hyperglycemia not resolved to G≤2 in 7d after antidiabetic treatment,G2 hyperglycemia not resolved to G≤1 in 21d,G2 alanine aminotransferase(ALT) increase in conjunction with total blood BL G≥2 without liver metastases,G≥3 ALT/aspartate aminotransferase increase for\>4d,G3 rash/maculopapular rash not resolved to G≤1 in 7d;treatment related toxicity causing≥7d omission in Cycle 1 or \>2 weeks delay in Cycle 2 in Part C. |
| Primary | Part B: Objective Response Rate (ORR) as Determined by Independent Central Review (ICR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | ORR was determined by dividing the number of participants who achieved confirmed complete response (CR) or partial response (PR) by the number of participants from the analysis population. ORR was assessed by ICR according to response evaluation criteria in solid tumors (RECIST) v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Primary | Parts D, I: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 232 weeks for Part D and 11 weeks for Part I | AE was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily had a causal relationship with the treatment. SAE was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the treatment period. |
| Secondary | Parts A, B, C, F, H, J: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 96, 59, 130 weeks for Parts A, B, C, F, H, J respectively | AE was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product and which did not necessarily had a causal relationship with the treatment. SAE was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the treatment period. |
| Secondary | Parts A, B, C, D, F, H, I, J: Objective Response Rate as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | ORR was determined by dividing the number of participants who achieved confirmed CR or PR by the number of participants from the analysis population. ORR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Parts A, B, C, D, F, H, I, J: Clinical Benefit Rate (CBR) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | CBR was determined by dividing the number of participants who achieved confirmed CR, PR as best overall response (BOR) or stable disease (SD) for ≥24 weeks by the number of participants from the analysis population. CBR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
| Secondary | Part B: Clinical Benefit Rate as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | CBR was determined by dividing the number of participants who achieved confirmed CR, PR as BOR or SD for ≥24 weeks by the number of participants from the analysis population. CBR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Parts A, B, C, D, F, H, I, J: Duration of Response (DOR) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | DOR was defined as the time interval from the date of the first occurrence of confirmed CR or PR to the date of the first documentation of disease progression or death due to disease progression, whichever occurred first. DOR was assessed by investigators/local radiologists according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression. |
| Secondary | Part B: Duration of Response as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | DOR was defined as the time interval from the date of the first occurrence of confirmed CR or PR to the date of the first documentation of disease progression or death due to disease progression, whichever occurred first. DOR was assessed by ICR according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression. |
| Secondary | Parts A, B, C, D, F, H, I, J: Progression-Free Survival (PFS) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | PFS was defined as time from the date of the first treatment intake to the date of the first documentation of objective PD according to RECIST v1.1, clinical PD or death due to any cause, whichever occurred first. PFS was assessed by investigators/local radiologists. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, an absolute increase of at least 5 mm in the sum. Appearance of 1 or more new lesions was also considered progression. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Cycle 1 Day 1 to Cycle 1 Day 28 (cycle duration=28 days) | The DLT-evaluable population included participants who received 1 cycle (28 days, oral administration), with intake of at least 75% of intended doses, unless they discontinued study treatment before Cycle 1 completion due to a DLT, and in Part A had an evaluable 18F-fluorestradiol (18F-FES) positron emission tomography (PET) scan at baseline and between Days 11 and 15 of first cycle. Any participant who developed a DLT in Part A despite absence of evaluable 18F-FES-PET scan was also included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Objective Response Rate (ORR) as Determined by Independent Central Review (ICR) | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| PRIMARY | Parts D, I: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 232 weeks for Part D and 11 weeks for Part I | The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A, B, C, F, H, J: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events | From first dose of study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration; approximately 94, 282, 144, 96, 59, 130 weeks for Parts A, B, C, F, H, J respectively | The safety population included all registered participants exposed to the study treatment, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Objective Response Rate as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Clinical Benefit Rate (CBR) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| SECONDARY | Part B: Clinical Benefit Rate as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | percentage of participants | NUMBER |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Duration of Response (DOR) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Part B: Duration of Response as Determined by Independent Central Review | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 278 weeks | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. Only participants with CR or PR (responders) were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Parts A, B, C, D, F, H, I, J: Progression-Free Survival (PFS) as Determined by Investigators/Local Radiologists | From first dose of study treatment administration (Day 1) up to maximum exposure of study treatment; approximately 90, 278, 140, 228, 92, 55, 7, 126 weeks for Parts A, B, C, D, F, H, I, J respectively | The efficacy population included all treated participants with measurable disease at study entry who provided a baseline and at least 1 post-baseline evaluable tumor assessment. Participants with an early progression as per RECIST v1.1 or who died from disease progression were also included in this set. | weeks | MEDIAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group391
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part A: Amcenestrant 20 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part A: Amcenestrant 150 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part A: Amcenestrant 200 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part A: Amcenestrant 400 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part A: Amcenestrant 600 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part A: Amcenestrant 300 mg BID | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part C: Amcenestrant 200 mg + Palbociclib 125 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part C: Amcenestrant 400 mg + Palbociclib 125 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part F: Amcenestrant 200 mg + Alpelisib 300 mg | 0 | Participants | ||
| Parts A, C, F, H, J: Number of Participants With Study Treatment-Related Dose-Limiting Toxicities (DLTs) | Part H: Amcenestrant 200 mg + Everolimus 5 mg | 0 | Participants |
1 to 10 of 391Source ClinicalTrials.gov
See all 391 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Amcenestrant 20 mg | 3 | |
| Overall Study | STARTED | Part A: Amcenestrant 150 mg | 3 | |
| Overall Study | STARTED | Part A: Amcenestrant 200 mg | 4 | |
| Overall Study | STARTED | Part A: Amcenestrant 400 mg | 3 | |
| Overall Study | STARTED | Part A: Amcenestrant 600 mg | 3 | |
| Overall Study | STARTED | Part A: Amcenestrant 300 mg BID | 6 | |
| Overall Study | STARTED | Part B: Amcenestrant 400 mg | 49 | |
| Overall Study | STARTED | Part C: Amcenestrant 200 mg + Palbociclib 125 mg | 9 | |
| Overall Study | STARTED | Part C: Amcenestrant 400 mg + Palbociclib 125 mg | 6 | |
| Overall Study | STARTED | Part D: Amcenestrant 200 mg + Palbociclib 125 mg | 30 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events3,904
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Part A: Amcenestrant 20 mg | 0 | 3 | 0 |
| other | Bronchitis | Infections and infestations | Part A: Amcenestrant 150 mg | 0 | 3 | 0 |
| other | Bronchitis | Infections and infestations | Part A: Amcenestrant 200 mg | 0 | 4 | 0 |
| other | Bronchitis | Infections and infestations | Part A: Amcenestrant 400 mg | 0 | 3 | 0 |
| other | Bronchitis | Infections and infestations | Part A: Amcenestrant 600 mg | 0 | 3 | 0 |
| other | Bronchitis | Infections and infestations | Part A: Amcenestrant 300 mg BID | 0 | 6 | 0 |
| other | Bronchitis | Infections and infestations | Part B: Amcenestrant 400 mg | 0 | 49 | 0 |
| other | Bronchitis | Infections and infestations | Part C: Amcenestrant 200 mg + Palbociclib 125 mg | 0 | 9 | 0 |
| other | Bronchitis | Infections and infestations | Part C: Amcenestrant 400 mg + Palbociclib 125 mg | 0 | 6 | 0 |
| other | Bronchitis | Infections and infestations | Part D: Amcenestrant 200 mg + Palbociclib 125 mg | 0 | 30 | 0 |
1 to 10 of 3,904Source ClinicalTrials.gov
See all 3,904 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Amcenestrant 20 mg | 1 | 3 |
| Total, all-cause mortality | Part A: Amcenestrant 150 mg | 1 | 3 |
| Total, all-cause mortality | Part A: Amcenestrant 200 mg | 0 | 4 |
| Total, all-cause mortality | Part A: Amcenestrant 400 mg | 0 | 3 |
| Total, all-cause mortality | Part A: Amcenestrant 600 mg | 1 | 3 |
| Total, all-cause mortality | Part A: Amcenestrant 300 mg BID | 0 | 6 |
| Total, all-cause mortality | Part B: Amcenestrant 400 mg | 4 | 49 |
| Total, all-cause mortality | Part C: Amcenestrant 200 mg + Palbociclib 125 mg | 1 | 9 |
| Total, all-cause mortality | Part C: Amcenestrant 400 mg + Palbociclib 125 mg | 0 | 6 |
| Total, all-cause mortality | Part D: Amcenestrant 200 mg + Palbociclib 125 mg | 0 | 30 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35840573 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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