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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001824-33 | EudraCT Number | ||
| U1111-1233-0486 | Other Identifier | UTN |
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The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.
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Primary Objective:
To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.
Secondary Objective:
Study duration per participant was approximately 59 months, which includes a 33- month treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole + Palbociclib | Active Comparator | Participants received letrozole 2.5 milligrams (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men. |
|
| Amcenestrant + Palbociclib | Experimental | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amcenestrant-matching placebo | Drug | Pharmaceutical form: Tablets Route of Administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method. | From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :8400075 | Daphne | Alabama | 36526 | United States | ||
| Investigational Site Number :8400083 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38889373 | Derived | Cortes J, Hurvitz SA, O'Shaughnessy J, Delaloge S, Iwata H, Rugo HS, Neven P, Kanagavel D, Cohen P, Paux G, Cartot-Cotton S, Stefanova-Urena M, Deyme L, Aouni J, Sebastien B, Bardia A. Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Primary Results From AMEERA-5. J Clin Oncol. 2024 Aug 1;42(22):2680-2690. doi: 10.1200/JCO.23.02036. Epub 2024 Jun 18. | |
| 35309087 |
| Label | URL |
|---|---|
| EFC15935 Plain Language Results Summary | View source |
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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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A total of 1068 participants were randomized, of which 2 participants were randomized but not exposed to study treatment. Randomization was stratified by De-novo metastatic disease (Yes or No); postmenopausal women (Yes or No); visceral metastasis defined by at least 1 liver, lung, brain metastasis, pleural, or peritoneal involvement (Yes or No).
The study was conducted at 249 active sites in 30 countries. A total of 1277 participants were screened between 14 October 2020 and 11 November 2021, of which 209 were screen failures. Screen failures were mainly due to not meeting selection criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Letrozole + Palbociclib | Participants received letrozole 2.5 milligram (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2021 | Jun 12, 2023 |
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| SAR439859 | Drug | Pharmaceutical form: Tablets Route of Administration: Oral |
|
|
| Palbociclib | Drug | Pharmaceutical form: Capsules/Tablets Route of Administration: Oral |
|
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| Letrozole | Drug | Pharmaceutical form: Capsules Route of Administration: Orally |
|
| Goserelin | Drug | Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous |
|
| Letrozole-matching placebo | Drug | Pharmaceutical form: Capsules Route of Administration: Orally |
|
| 12-month Progression-free Survival (PFS) Rate | Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization. | Month 12 |
| Percentage of Participants With Objective Response | Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 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. | From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks) |
| Duration of Response (DOR) | DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
| Percentage of Participants With Clinical Benefit | Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions & normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. | From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
| Progression-free Survival on Next Line of Therapy (PFS2) | PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
| Pharmacokinetics: Plasma Concentrations of Amcenestrant | Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol. | Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose |
| Pharmacokinetics: Plasma Concentrations of Palbociclib | Palbociclib plasma concentrations at specified time points were reported. | Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose |
| Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores | EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, & Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) & GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL=higher level of functioning, & higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported in this outcome measure. | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores | QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact & side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales & single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) & 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, & upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean & SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value & stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported. | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores | EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported. | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
| Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score | EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for VAS was reported in this outcome measure. | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
| Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score | EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) & VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, & extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state & lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for health utility index value score was reported in this outcome measure. | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
| Time to First Chemotherapy | Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression. | From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks) |
| Number of Participants With Hematological Abnormalities During the Treatment Period | Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks) |
| Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period | Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure. | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks) |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Investigational Site Number :8400066 | Tucson | Arizona | 85712 | United States |
| Investigational Site Number :8400038 | Fullerton | California | 92835 | United States |
| Investigational Site Number :8400056 | Los Alamitos | California | 90720 | United States |
| Investigational Site Number :8400029 | Santa Monica | California | 90404 | United States |
| Investigational Site Number :8400025 | Denver | Colorado | 80262 | United States |
| Investigational Site Number :8400059 | Lakeland | Florida | 33805 | United States |
| Investigational Site Number :8400053 | Orlando | Florida | 32804 | United States |
| Investigational Site Number :8400081 | Palm Bay | Florida | 32901 | United States |
| Investigational Site Number :8400055 | Athens | Georgia | 30607 | United States |
| Investigational Site Number :8400016 | Atlanta | Georgia | 30342 | United States |
| Investigational Site Number :8400034 | Savannah | Georgia | 31405 | United States |
| Investigational Site Number :8400035 | Thomasville | Georgia | 31792 | United States |
| Investigational Site Number :8400039 | Chicago | Illinois | 60612 | United States |
| Investigational Site Number :8400008 | Fort Wayne | Indiana | 46804 | United States |
| Investigational Site Number :8400006 | Iowa City | Iowa | 52242 | United States |
| Investigational Site Number :8400013 | Westwood | Kansas | 66205-2003 | United States |
| Investigational Site Number :8400028 | Scarborough | Maine | 04074-9308 | United States |
| Investigational Site Number :8400017 | Boston | Massachusetts | 02114 | United States |
| Investigational Site Number :8400076 | Danvers | Massachusetts | 01923 | United States |
| Investigational Site Number :8400077 | Newton | Massachusetts | 02463 | United States |
| Investigational Site Number :8400002 | Ann Arbor | Michigan | 48109 | United States |
| Investigational Site Number :8400005 | Kansas City | Missouri | 64111 | United States |
| Investigational Site Number :8400004 | St Louis | Missouri | 63141 | United States |
| Investigational Site Number :8400058 | Las Vegas | Nevada | 89102 | United States |
| Investigational Site Number :8400015 | New Brunswick | New Jersey | 08901-1914 | United States |
| Investigational Site Number :8400024 | Paramus | New Jersey | 00000 | United States |
| Investigational Site Number :8400010 | New York | New York | 10016 | United States |
| Investigational Site Number :8400023 | Stony Brook | New York | 11794-8121 | United States |
| Investigational Site Number :8400009 | Winston-Salem | North Carolina | 27157 | United States |
| Investigational Site Number :8400067 | Tigard | Oregon | 97223 | United States |
| Investigational Site Number :8400001 | Pittsburgh | Pennsylvania | 15232 | United States |
| Investigational Site Number :8400073 | Austin | Texas | 78745 | United States |
| Investigational Site Number :8400072 | Dallas | Texas | 75231 | United States |
| Investigational Site Number :8400070 | Dallas | Texas | 75246 | United States |
| Investigational Site Number :8400080 | Denton | Texas | 76021 | United States |
| Investigational Site Number :8400061 | Houston | Texas | 77024 | United States |
| Investigational Site Number :8400068 | Houston | Texas | 77024 | United States |
| Investigational Site Number :8400084 | Plano | Texas | 75093 | United States |
| Investigational Site Number :8400086 | The Woodlands | Texas | 77380 | United States |
| Investigational Site Number :8400078 | Waco | Texas | 76712 | United States |
| Investigational Site Number :8400082 | Webster | Texas | 77598 | United States |
| Investigational Site Number :8400085 | Blacksburg | Virginia | 24060 | United States |
| Investigational Site Number :8400069 | Winchester | Virginia | 22601 | United States |
| Investigational Site Number :0320001 | CABA | Buenos Aires | C1012AAR | Argentina |
| Investigational Site Number :0320005 | CABA | Buenos Aires | C1019ABS | Argentina |
| Investigational Site Number :0320008 | Capital Federal | Buenos Aires | C1417DTB | Argentina |
| Investigational Site Number :0320006 | Pergamino | Buenos Aires | B2700CPM | Argentina |
| Investigational Site Number :0320010 | Córdoba | Córdoba Province | 5000 | Argentina |
| Investigational Site Number :0320002 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number :0320004 | Buenos Aires | C1125ABD | Argentina |
| Investigational Site Number :0320003 | La Rioja | 5300 | Argentina |
| Investigational Site Number :0320009 | Mar del Plata | B7600FYK | Argentina |
| Investigational Site Number :0320007 | Salta | 4400 | Argentina |
| Investigational Site Number :0360004 | Macquarie Park | New South Wales | 2109 | Australia |
| Investigational Site Number :0360005 | Randwick | New South Wales | 2031 | Australia |
| Investigational Site Number :0360003 | Wahroonga | New South Wales | 2076 | Australia |
| Investigational Site Number :0360002 | Richmond | Victoria | 3121 | Australia |
| Investigational Site Number :0360001 | Nedlands | Western Australia | 6009 | Australia |
| Investigational Site Number :0400001 | Graz | 8036 | Austria |
| Investigational Site Number :0560003 | Brussels | BE-1200 | Belgium |
| Investigational Site Number :0560004 | Charleroi | B-6000 | Belgium |
| Investigational Site Number :0560001 | Leuven | 3000 | Belgium |
| Investigational Site Number :0560002 | Namur | 5000 | Belgium |
| Investigational Site Number :0760005 | Porto Alegre | Rio Grande do Sul | 90035 003 | Brazil |
| Investigational Site Number :0760006 | Porto Alegre | Rio Grande do Sul | 91350-250 | Brazil |
| Investigational Site Number :0760007 | São Paulo | São Paulo | 01509-900 | Brazil |
| Investigational Site Number :0760003 | São Paulo | São Paulo | 04014-002 | Brazil |
| Investigational Site Number :0760004 | Rio de Janeiro | 20230-130 | Brazil |
| Investigational Site Number :0760008 | São Paulo | 04321-120 | Brazil |
| Investigational Site Number :1000004 | Burgas | 8000 | Bulgaria |
| Investigational Site Number :1000005 | Dobrich | Bulgaria |
| Investigational Site Number :1000008 | Rousse | 7002 | Bulgaria |
| Investigational Site Number :1000001 | Sofia | 1797 | Bulgaria |
| Investigational Site Number :1240004 | Kingston | Ontario | K7L 2V7 | Canada |
| Investigational Site Number :1240002 | Toronto | Ontario | M4N 3M5 | Canada |
| Investigational Site Number :1240007 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Investigational Site Number :1240014 | Montreal | Quebec | H3T 1S6 | Canada |
| Investigational Site Number :1240005 | Montreal | Quebec | H4A 3J1 | Canada |
| Investigational Site Number :1520005 | La Serena | Coquimbo Region | 1720430 | Chile |
| Investigational Site Number :1520004 | Temuco | La Araucanía | 4810561 | Chile |
| Investigational Site Number :1520009 | Talca | Maule Region | Chile |
| Investigational Site Number :1520011 | Santaigo | Reg Metropolitana de Santiago | 8241470 | Chile |
| Investigational Site Number :1520006 | Santiago | Reg Metropolitana de Santiago | 7650568 | Chile |
| Investigational Site Number :1520002 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number :1520001 | Viña del Mar | Valparaiso | 2520598 | Chile |
| Investigational Site Number :1520007 | Santiago | 7500921 | Chile |
| Investigational Site Number :1520003 | Santiago | Chile |
| Investigational Site Number :1560038 | Baoding | 071000 | China |
| Investigational Site Number :1560008 | Beijing | 100142 | China |
| Investigational Site Number :1560035 | Beijing | 100730 | China |
| Investigational Site Number :1560003 | Changchun | 130021 | China |
| Investigational Site Number :1560036 | Changchun | 130041 | China |
| Investigational Site Number :1560013 | Chengdu | 610041 | China |
| Investigational Site Number :1560019 | Chongqing | 400030 | China |
| Investigational Site Number :1560031 | Dalian | 116011 | China |
| Investigational Site Number :1560021 | Dalian | 116027 | China |
| Investigational Site Number :1560054 | Deyang | 618000 | China |
| Investigational Site Number :1560043 | Fuzhou | 354200 | China |
| Investigational Site Number :1560025 | Guangzhou | 510080 | China |
| Investigational Site Number :1560006 | Hangzhou | 310003 | China |
| Investigational Site Number :1560007 | Hangzhou | 310009 | China |
| Investigational Site Number :1560002 | Hangzhou | 310016 | China |
| Investigational Site Number :1560005 | Hangzhou | 310022 | China |
| Investigational Site Number :1560011 | Harbin | 150081 | China |
| Investigational Site Number :1560041 | Hefei | 233004 | China |
| Investigational Site Number :1560018 | Jinan | 250013 | China |
| Investigational Site Number :1560046 | Jinan | 250117 | China |
| Investigational Site Number :1560051 | Jining | China |
| Investigational Site Number :1560017 | Linyi | 276000 | China |
| Investigational Site Number :1560055 | Luoyang | 471003 | China |
| Investigational Site Number :1560048 | Neijiang | 641003 | China |
| Investigational Site Number :1560001 | Shanghai | 200032 | China |
| Investigational Site Number :1560037 | Shaoguan | 512025 | China |
| Investigational Site Number :1560028 | Tianjin | 300060 | China |
| Investigational Site Number :1560033 | Wuhan | 430060 | China |
| Investigational Site Number :1560024 | Wuhan | 430079 | China |
| Investigational Site Number :1560045 | Xi'an | 710004 | China |
| Investigational Site Number :1560044 | Xi'an | 710061 | China |
| Investigational Site Number :1560027 | Xuzhou | 221009 | China |
| Investigational Site Number :1560049 | Yantai | 264000 | China |
| Investigational Site Number :1560022 | Zhengzhou | 450008 | China |
| Investigational Site Number :2030001 | Brno | 65653 | Czechia |
| Investigational Site Number :2030002 | Prague | 12808 | Czechia |
| Investigational Site Number :2460001 | Helsinki | 00029 | Finland |
| Investigational Site Number :2460002 | Tampere | 33520 | Finland |
| Investigational Site Number :2460003 | Turku | FIN-20520 | Finland |
| Investigational Site Number :2500009 | Nice | 06189 | France |
| Investigational Site Number :2500003 | Paris | 75010 | France |
| Investigational Site Number :2500001 | Paris | 75248 | France |
| Investigational Site Number :2500006 | Poitiers | 86021 | France |
| Investigational Site Number :2500007 | Saint-Cloud | 92210 | France |
| Investigational Site Number :2500002 | Saint-Herblain | 44805 | France |
| Investigational Site Number :2500010 | Strasbourg | 67033 | France |
| Investigational Site Number :2500005 | Toulouse | 31059 | France |
| Investigational Site Number :2500004 | Villejuif | 94800 | France |
| Investigational Site Number :2680005 | Batumi | 6000 | Georgia |
| Investigational Site Number :2680006 | Kutaisi | 4600 | Georgia |
| Investigational Site Number :2680001 | Tbilisi | 0112 | Georgia |
| Investigational Site Number :2680002 | Tbilisi | 0144 | Georgia |
| Investigational Site Number :2680004 | Tbilisi | 0159 | Georgia |
| Investigational Site Number :2680007 | Tbilisi | 0159 | Georgia |
| Investigational Site Number :2680003 | Tbilisi | 0168 | Georgia |
| Investigational Site Number :2760006 | Bottrop | 46236 | Germany |
| Investigational Site Number :2760003 | Münster | 48149 | Germany |
| Investigational Site Number :2760007 | Oldenburg in Holstein | 23758 | Germany |
| Investigational Site Number :2760001 | Ulm | 89075 | Germany |
| Investigational Site Number :3480008 | Budapest | 1115 | Hungary |
| Investigational Site Number :3480005 | Győr | 9023 | Hungary |
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| Investigational Site Number :3480010 | Miskolc | 3526 | Hungary |
| Investigational Site Number :3480001 | Nyíregyháza | 4400 | Hungary |
| Investigational Site Number :3800008 | Meldola (FC) | Emilia-Romagna | 47014 | Italy |
| Investigational Site Number :3800003 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number :3800007 | Monza | Monza E Brianza | 20052 | Italy |
| Investigational Site Number :3800010 | Bologna | 40138 | Italy |
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| Investigational Site Number :3920012 | Kagoshima | Kagoshima-ken | 892-0833 | Japan |
| Investigational Site Number :3920014 | Yokohama | Kanagawa | 222-0036 | Japan |
| Investigational Site Number :3920006 | Yokohama | Kanagawa | 241-8515 | Japan |
| Investigational Site Number :3920020 | Sendai | Miyagi | 980-0803 | Japan |
| Investigational Site Number :3920022 | Miyazaki | Miyazaki | 880-8510 | Japan |
| Investigational Site Number :3920008 | Osaka | Osaka | 540-0006 | Japan |
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| Investigational Site Number :3920013 | Hidaka-shi | Saitama | 350-1241 | Japan |
| Investigational Site Number :3920021 | Shizuoka | Shizuoka | 420-8527 | Japan |
| Investigational Site Number :3920003 | Koto-ku | Tokyo | 135-8550 | Japan |
| Investigational Site Number :3920015 | Meguro-ku | Tokyo | 152-8902 | Japan |
| Investigational Site Number :3920005 | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Investigational Site Number :5280006 | Arnhem | 6815 AD | Netherlands |
| Investigational Site Number :5280005 | Delft | 2625 AD | Netherlands |
| Investigational Site Number :5280001 | Maastricht | 6229 HX | Netherlands |
| Investigational Site Number :6160007 | Poznan | Greater Poland Voivodeship | 61-866 | Poland |
| Investigational Site Number :6160002 | Tomaszów Mazowiecki | Lódzkie | 97-200 | Poland |
| Investigational Site Number :6200005 | Almada | 2801-951 | Portugal |
| Investigational Site Number :6200001 | Lisbon | 1649-035 | Portugal |
| Investigational Site Number :6200002 | Porto | 4200-319 | Portugal |
| Investigational Site Number :6430007 | Arkhangelsk | 163045 | Russia |
| Investigational Site Number :6430004 | Krasnogorskiy District | 143423 | Russia |
| Investigational Site Number :6430008 | Moscow | 115478 | Russia |
| Investigational Site Number :6430003 | Moscow | 117186 | Russia |
| Investigational Site Number :6430005 | Moscow | 117997 | Russia |
| Investigational Site Number :6430006 | Moscow | 129090 | Russia |
| Investigational Site Number :6430009 | Moscow Region | 143442 | Russia |
| Investigational Site Number :6430001 | Saint Petersburg | 197758 | Russia |
| Investigational Site Number :6430010 | Saint Petersburg | 199034 | Russia |
| Investigational Site Number :7020002 | Singapore | 119228 | Singapore |
| Investigational Site Number :7020004 | Singapore | 169610 | Singapore |
| Investigational Site Number :7020001 | Singapore | 329563 | Singapore |
| Investigational Site Number :7100004 | Cape Town | 7570 | South Africa |
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| Investigational Site Number :4100006 | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Investigational Site Number :4100005 | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Investigational Site Number :4100007 | Seoul | Seoul-teukbyeolsi | 02841 | South Korea |
| Investigational Site Number :4100004 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number :4100003 | Seoul | Seoul-teukbyeolsi | 110-744 | South Korea |
| Investigational Site Number :4100002 | Seoul | Seoul-teukbyeolsi | 135-710 | South Korea |
| Investigational Site Number :4100001 | Seoul | Seoul-teukbyeolsi | 138-878 | South Korea |
| Investigational Site Number :4100009 | Seochogu | 6591 | South Korea |
| Investigational Site Number :4100008 | Seongnam-si, Gyeonggi-do | 13496 | South Korea |
| Investigational Site Number :7240011 | Barcelona | Barcelona [Barcelona] | 08017 | Spain |
| Investigational Site Number :7240008 | Barcelona / Sabadell | Castille and León | 08208 | Spain |
| Investigational Site Number :7240003 | Santiago de Compostela | Galicia [Galicia] | 15706 | Spain |
| Investigational Site Number :7240004 | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Investigational Site Number :7240006 | Madrid / Madrid | Madrid, Comunidad de | 28007 | Spain |
| Investigational Site Number :7240002 | Madrid / Madrid | Madrid, Comunidad de | 28050 | Spain |
| Investigational Site Number :7240005 | Valencia | Valenciana, Comunidad | 46010 | Spain |
| Investigational Site Number :7240001 | Madrid | 28041 | Spain |
| Investigational Site Number :7240007 | Málaga | 29010 | Spain |
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| Investigational Site Number :1580007 | Kaohsiung City | 807 | Taiwan |
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| Investigational Site Number :7920006 | Adana | 01120 | Turkey (Türkiye) |
| Investigational Site Number :7920008 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number :7920009 | Ankara | 06200 | Turkey (Türkiye) |
| Investigational Site Number :7920007 | Antalya | 07070 | Turkey (Türkiye) |
| Investigational Site Number :7920005 | Bornova | 35100 | Turkey (Türkiye) |
| Investigational Site Number :7920013 | Diyarbakır | 21100 | Turkey (Türkiye) |
| Investigational Site Number :7920003 | Edirne | 22030 | Turkey (Türkiye) |
| Investigational Site Number :7920001 | Istanbul | 34214 | Turkey (Türkiye) |
| Investigational Site Number :7920011 | Istanbul | 34457 | Turkey (Türkiye) |
| Investigational Site Number :7920004 | Istanbul | 34722 | Turkey (Türkiye) |
| Investigational Site Number :7920012 | Izmir | 0000 | Turkey (Türkiye) |
| Investigational Site Number :7920010 | Kocaeli | 41380 | Turkey (Türkiye) |
| Investigational Site Number :7920002 | Malatya | 44280 | Turkey (Türkiye) |
| Investigational Site Number :8040004 | Kharkiv | 61103 | Ukraine |
| Investigational Site Number :8040010 | Kharkiv | 61166 | Ukraine |
| Investigational Site Number :8040001 | Kryvyi Rih | 50048 | Ukraine |
| Investigational Site Number :8040002 | Odesa | 65025 | Ukraine |
| Investigational Site Number :8040007 | Vinnytsia | 21029 | Ukraine |
| Investigational Site Number :8260001 | Glasgow | Central Bedfordshire | G12 0YN | United Kingdom |
| Investigational Site Number :8260002 | Edinburgh | Edinburgh, City of | EH4 2XU | United Kingdom |
| Investigational Site Number :8260005 | Blackburn | Lancashire | BB2 3HH | United Kingdom |
| Derived |
| Bardia A, Cortes J, Hurvitz SA, Delaloge S, Iwata H, Shao ZM, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O'Shaughnessy J. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Mar 15;14:17588359221083956. doi: 10.1177/17588359221083956. eCollection 2022. |
| FG001 |
| Amcenestrant + Palbociclib |
Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on safety population which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, analyzed according to the treatment arm they actually received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Letrozole + Palbociclib | Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg, PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). |
| BG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) | PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | Analysis was performed on the ITT population which included all enrolled participants (i.e., who signed the informed consent form and for whom there was a confirmation of successful allocation of a randomization number by Interactive Response Technology [IRT]. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks) |
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| Secondary | Overall Survival (OS) | OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method. | Analysis was performed on the ITT population. | Posted | Median | 95% Confidence Interval | months | From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
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| Secondary | 12-month Progression-free Survival (PFS) Rate | Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization. | Analysis was performed on the ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | Percentage of Participants With Objective Response | Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 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. | Analysis was performed on the ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 81 weeks) |
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| Secondary | Duration of Response (DOR) | DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | Analysis was performed on a subset of participants who had objective response. | Posted | Median | 95% Confidence Interval | months | From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
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| Secondary | Percentage of Participants With Clinical Benefit | Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions & normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. | Analysis was performed on the ITT population. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
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| Secondary | Progression-free Survival on Next Line of Therapy (PFS2) | PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. | Analysis was performed on the ITT population. | Posted | Median | 95% Confidence Interval | months | From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum duration: 81 weeks) |
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| Secondary | Pharmacokinetics: Plasma Concentrations of Amcenestrant | Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol. | Analysis was performed on the Pharmacokinetic-evaluable (amcenestrant) population that included all participants who took at least 1 dose of study intervention, and with at least one evaluable plasma concentration of amcenestrant post-treatment. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | nanograms per milliliter | Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose |
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| Secondary | Pharmacokinetics: Plasma Concentrations of Palbociclib | Palbociclib plasma concentrations at specified time points were reported. | Analysis was performed on the Pharmacokinetic-evaluable (palbociclib) population that included all participants who took at least 1 dose of study intervention, and with at least one evaluable plasma concentration of palbociclib post-treatment. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | nanograms per milliliter | Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores | EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, & Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) & GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL=higher level of functioning, & higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported in this outcome measure. | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores | QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact & side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales & single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) & 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, & upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean & SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value & stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported. | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores | EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported. | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
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| Secondary | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score | EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for VAS was reported in this outcome measure. | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
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| Secondary | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score | EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) & VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, & extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state & lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for health utility index value score was reported in this outcome measure. | Analysis was performed on safety population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks]) |
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| Secondary | Time to First Chemotherapy | Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression. | Analysis was performed on the ITT population. | Posted | Median | 95% Confidence Interval | months | From randomization to the start date of the first chemotherapy (maximum duration: 81 weeks) |
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| Secondary | Number of Participants With Hematological Abnormalities During the Treatment Period | Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks) |
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| Secondary | Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period | Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure. | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Count of Participants | Participants | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 112 weeks) |
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Adverse Events (AE) data was collected from Baseline up to 30 days after last dose of study treatment (maximum exposure: 112 weeks), deaths were collected from Baseline up to the end of study (26 May 2023)
Reported SAEs and NSAEs were assessed for safety population. All-Cause Mortality data collected during study was assessed for all randomized participants. Disease progression related death were not reported as AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Letrozole + Palbociclib | Participants received letrozole 2.5 mg capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg, PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). | 41 | 534 | 68 | 533 | 448 | 533 |
| EG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). | 45 | 534 | 77 | 533 | 412 | 533 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis Bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Focal Peritonitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Paracancerous Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Adenocarcinoma Of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Diffuse Large B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Gallbladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Rectal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia Of Malignant Disease | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psychomotor Hyperactivity | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Heart Valve Incompetence | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatorenal Failure | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Axillary Mass | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood Follicle Stimulating Hormone Decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal Procedural Complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal Stoma Complication | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural Pneumothorax | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Jun 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077289 | Letrozole |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| OG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
| Amcenestrant + Palbociclib |
Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
|
|
|
|
|
|
| OG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
| OG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
| OG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
| OG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
| OG001 | Amcenestrant + Palbociclib | Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 109 weeks). |
|
|
|
|
|
|
|
|