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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003131-11 | EudraCT Number |
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The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xentuzumab/everolimus/exemestane | Experimental |
| |
| Placebo/everolimus/exemestane | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xentuzumab | Drug | Intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions. | From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) defined as the time from randomisation until death from any cause. For patients with 'event' as an outcome for OS: OS[days] = date of outcome - date of randomisation + 1. For patients with 'censored' as an outcome for OS: OS (censored)[days] = date of outcome - date of randomisation + 1. | From randomisation until death from any cause, up to 995 days. |
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Inclusion Criteria:
Documented histologically confirmed breast cancer with ERand/ or PgR-positive and HER2-negative status
Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
Archival tumour sample available at the time of informed consent and provided to the central laboratory around the time of randomisation. Patients must provide a formalin-fixed paraffin embedded (FFPE) tissue biopsy sample preferably taken at the time of presentation with recurrent or metastatic disease (provision of a biopsy sample taken from the bone is not acceptable).
Patients must satisfy the following criteria for prior therapy:
Patients must have
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Fasting glucose <8.9 mmol/L (<160 mg/dL) and HbA1c <8.0%
Adequate organ function
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | United States | ||
| Cancer Treatment Centers of America at Western Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37308971 | Derived | Schmid P, Cortes J, Joaquim A, Janez NM, Morales S, Diaz-Redondo T, Blau S, Neven P, Lemieux J, Garcia-Saenz JA, Hart L, Biyukov T, Baktash N, Massey D, Burris HA 3rd, Rugo HS. XENERA-1: a randomised double-blind Phase II trial of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in patients with hormone receptor-positive/HER2-negative metastatic breast cancer and non-visceral disease. Breast Cancer Res. 2023 Jun 12;25(1):67. doi: 10.1186/s13058-023-01649-w. | |
| 33451345 |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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All patients were screened for eligibility prior to participation in the trial. Patients were screened from 53 investigational sites in 11 countries, to ensure that they (the patients) strictly met all inclusion and none of the exclusion criteria. Screening could occur 1-28 days prior to randomisation to study treatment, patients were not to be randomised if any of the entry criteria were violated. Re-screening was allowed but only once per patient.
A multi-centre, double-blind, placebo-controlled, randomised trial which assess the efficacy of of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with Hormon Receptor+ (HR+)/ Human epidermal growth factor receptor 2 (HER2)- advanced or metastatic breast cancer and non-visceral disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane | 1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
| 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 | Nov 25, 2021 | Aug 8, 2022 |
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| Placebo |
| Drug |
Intravenous infusion |
|
| Everolimus | Drug | Tablet |
|
| Exemestane | Drug | Tablet |
|
| Number of Patients With Disease Control (DC) | Disease control (DC) was defined as a best overall response (BOR) of either complete response (CR), partial response (PR), stable disease (SD) or Non-CR/No-PD. SD and Non-CR/Non-PR must have been observed up until at least week 24 tumor assessment. BOR was defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) based on all evaluable tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered. DC was assessed by independent reviewers. | From randomisation until the earliest of progressive disease or death from any cause, up to 892 days. |
| Duration of Disease Control (DC) | Duration of disease control (DC), defined as the time from randomisation until the earliest of disease progression (according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment) or death from any cause, among patients with DC. Duration of DC was assessed by independent reviewers. The duration of DC was calculated as followed: For patients with disease progression or death: Duration of DC [days] = date of outcome - date of randomisation + 1 For patients without disease progression or death: Duration of DC (censored) [days] = date of outcome - date of randomisation + 1 | From randomisation until the earliest of progressive disease or death from any cause, up to 892 days. |
| Number of Participants With Objective Response (OR) | Number of participants with objective response (OR) by independent assessment. OR is defined as a best overall response of complete response (CR) or partial response (PR). Best overall response is defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) and will consider all tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered. | From randomisation until end of treatment, up to 892 days. |
| Time to Pain Progression or Intensification of Pain Palliation | Time to pain progression or intensification of pain palliation was defined as the time from randomisation until the earliest of:
| From randomisation until the earliest of pain progression, intensification of pain palliation, death or the time point of progression free survival analysis, up to 843 days. |
| Goodyear |
| Arizona |
| 85338 |
| United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| University Cancer and Blood Center | Athens | Georgia | 30607 | United States |
| Hematology Oncology of Indiana | Indianapolis | Indiana | 46260 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| HCA MidAmerica Division, Inc. | Kansas City | Missouri | 64132 | United States |
| Hematology Oncology Associates of Rockland | Nyack | New York | 10960 | United States |
| Southwestern Regional Medical Center | Tulsa | Oklahoma | 74133 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Utah Cancer Specialists Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| The Tweed Hospital | Tweed Heads | New South Wales | 2485 | Australia |
| Peninsula Haematology & Oncology | Frankston | Victoria | 3199 | Australia |
| Brussels - UNIV Saint-Luc | Brussels | 1200 | Belgium |
| Brussels - UNIV UZ Brussel | Jette | 1090 | Belgium |
| Kortrijk - HOSP AZ Groeninge Kennedylaan | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU de Quebec-Universite Laval Research Centre | Québec | G1S 4L8 | Canada |
| INS Sainte Catherine | Avignon | 84000 | France |
| HOP Victor Hugo | Le Mans | 72000 | France |
| INS Paoli-Calmettes | Marseille | 13009 | France |
| INS Curie | Paris | 75248 | France |
| HOP Européen G. Pompidou | Paris | 75908 | France |
| HOP Lyon Sud | Pierre-Bénite | 69495 | France |
| INS Claudius Regaud IUCT-Oncopole | Toulouse | 31059 | France |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Vincentius-Diakonissen-Kliniken gAG | Karlsruhe | 76135 | Germany |
| General Hospital of Athens "Alexandra" | Athens | 11528 | Greece |
| University General Hospital of Heraklion | Heraklion | 71110 | Greece |
| University Hospital of Larisa, Oncology Clinic | Larissa | 41334 | Greece |
| Metropolitan Hospital, Oncology Clinic | Neo Faliro, Athens | 18547 | Greece |
| Euromedica Kyanous Stavros General Hospital | Thessaloniki | 54645 | Greece |
| Istituto Nazionale IRCCS Tumori Fondazione Pascale | Naples | 80131 | Italy |
| Iov, Irccs | Padova | 35128 | Italy |
| Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | 00189 | Italy |
| Fundação Champalimaud, | Lisbon | 1400-038 | Portugal |
| Hospital Beatriz Ângelo | Loures | 2674-514 | Portugal |
| Centro Hospitalar de Vila Nova de Gaia | Vila Nova de Gaia | 4434-502 | Portugal |
| Hospital Teresa Herrera | A Coruña | 15006 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| Clínica Quirón de Valencia | Valencia | 46010 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Derived |
| Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8. |
| FG001 | Placebo + 10 mg Everolimus + 25 mg Exemestane | Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
| Treated |
|
| On-treatment at Cut-off Date for Primary Analysis |
|
| COMPLETED | Completed = Number of participants on treatment at the final analysis cut-off date |
|
| NOT COMPLETED |
|
|
Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane | 1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
| BG001 | Placebo + 10 mg Everolimus + 25 mg Exemestane | Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions. | Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. | Posted | Median | 95% Confidence Interval | Months | From randomisation until the earliest of disease progression, death or the time point of primary PFS analysis, up to 892 days. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) defined as the time from randomisation until death from any cause. For patients with 'event' as an outcome for OS: OS[days] = date of outcome - date of randomisation + 1. For patients with 'censored' as an outcome for OS: OS (censored)[days] = date of outcome - date of randomisation + 1. | Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. | Posted | Median | 95% Confidence Interval | Months | From randomisation until death from any cause, up to 995 days. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Disease Control (DC) | Disease control (DC) was defined as a best overall response (BOR) of either complete response (CR), partial response (PR), stable disease (SD) or Non-CR/No-PD. SD and Non-CR/Non-PR must have been observed up until at least week 24 tumor assessment. BOR was defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) based on all evaluable tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered. DC was assessed by independent reviewers. | Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. | Posted | Count of Participants | Participants | From randomisation until the earliest of progressive disease or death from any cause, up to 892 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Disease Control (DC) | Duration of disease control (DC), defined as the time from randomisation until the earliest of disease progression (according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment) or death from any cause, among patients with DC. Duration of DC was assessed by independent reviewers. The duration of DC was calculated as followed: For patients with disease progression or death: Duration of DC [days] = date of outcome - date of randomisation + 1 For patients without disease progression or death: Duration of DC (censored) [days] = date of outcome - date of randomisation + 1 | Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. Only participants with disease control are reported. | Posted | Median | 95% Confidence Interval | Months | From randomisation until the earliest of progressive disease or death from any cause, up to 892 days. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Objective Response (OR) | Number of participants with objective response (OR) by independent assessment. OR is defined as a best overall response of complete response (CR) or partial response (PR). Best overall response is defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) and will consider all tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered. | Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. | Posted | Count of Participants | Participants | From randomisation until end of treatment, up to 892 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Pain Progression or Intensification of Pain Palliation | Time to pain progression or intensification of pain palliation was defined as the time from randomisation until the earliest of:
| Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. | Posted | Median | 95% Confidence Interval | Months | From randomisation until the earliest of pain progression, intensification of pain palliation, death or the time point of progression free survival analysis, up to 843 days. |
|
[All-cause mortality]: From signing informed consent until end of study, up to 1106 days. [Serious and other adverse events]: From first drug administration until end of treatment + 42 days of residual effect period, up to 939 days.
[All-cause mortality]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not.
[Serious and other adverse events]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.
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 | 1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane | 1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. | 6 | 52 | 13 | 50 | 48 | 50 |
| EG001 | Placebo + 10 mg Everolimus + 25 mg Exemestane | Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. | 10 | 51 | 18 | 51 | 50 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tongue abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oophorectomy bilateral | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim, Call Centre | 018002430127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2021 | Aug 8, 2022 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C588089 | xentuzumab |
| D000068338 | Everolimus |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Placebo + 10 mg Everolimus + 25 mg Exemestane |
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
|
|
|
| Placebo + 10 mg Everolimus + 25 mg Exemestane |
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
|
|
Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal. |
|
|
|
|
|
|