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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004631-36 | EudraCT Number |
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The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer
This Phase Ib study will investigate the safety and anti-tumor activity of daily oral doses MEN1611 in combination with Trastuzumab with/without Fulvestrant in female and male patients affected by advanced or metastatic HER2-positive breast cancer. Fulvestrant will be added to the post-menopausal patients with hormone-sensitive disease.
MEN1611 is an investigational drug which blocks a protein called PI3K (phosphoinositide 3-kinase) involved in cancer cells growth. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.
This Phase IB will start with a dose escalation part (Step 1) to identify the MTD of MEN1611 given in combination with Trastuzumab with/without Fulvestrant.
The study will continue with a cohort expansion (Step 2) to investigate the anti-tumor activity of the selected MEN1611 dose level considered to be tolerable by a Safety Review Committee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEN1611 | Experimental | MEN1611 + Trastuzumab +/- Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEN1611 | Drug | MEN1611 oral dose administered twice daily for a continuous 28-day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MTD of MEN1611 in Combination With Trastuzumab ± Fulvestrant | MTD was defined as the highest dose level at which no more than 1 participant experienced a DLT during the 28-day DLT assessment window. | Up to 28 Days |
| Number of Participants With DLTs of MEN1611 in Combination With Trastuzumab ± Fulvestrant | DLT was defined as the occurrence of any of the protocol defined adverse drug reactions (ADRs) related to the combination regimens or to MEN1611 alone and unrelated to the participants' underlying disease or concomitant medication occurring during 28 days after the first MEN1611 administration. | Up to 28 days |
| RP2D of MEN1611 in Combination With Trastuzumab ± Fulvestrant | RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant experienced a DLT during the DLT assessment window (28days), or the maximum dose judged to be tolerable. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | BOR was defined as percentage of participants who had a best overall response to therapy of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) and was defined according to Response Evaluation Criteria in Solid Tumors version 1.1 assessment locally performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine Piccart, MD PhD | Institute Jules Bordet - Boulevard De Waterloo 125 - B-1000 Brussels, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Cross Hospital Inc. | Fort Lauderdale | Florida | 33308 | United States | ||
| Detroit Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36913051 | Derived | Fiascarelli A, Merlino G, Capano S, Talucci S, Bisignano D, Bressan A, Bellarosa D, Carrisi C, Paoli A, Bigioni M, Tunici P, Irrissuto C, Salerno M, Arribas J, de Stanchina E, Scaltriti M, Binaschi M. Antitumor activity of the PI3K delta-sparing inhibitor MEN1611 in PIK3CA mutated, trastuzumab-resistant HER2 + breast cancer. Breast Cancer Res Treat. 2023 May;199(1):13-23. doi: 10.1007/s10549-023-06895-2. Epub 2023 Mar 13. |
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The study included a Dose Escalation part and a Dose Expansion part. The Dose Escalation part of the study included Cohorts 1 and 2.
It was prespecified that 3 participants who enrolled in Dose Expansion Cohort were to be included in the Dose-Limiting Toxicity (DLT) population. As prespecified, data were collected for the DLT population for the Maximum Tolerated Dose (MTD), DLT, Recommended Phase 2 Dose (RP2D) Outcome Measures,
A total of 73 participants were screened for study eligibility, of which 11 were considered as screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Escalation Cohort 1 | Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
| FG001 | Dose Escalation Cohort 2 |
| 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 | Mar 3, 2022 | Feb 18, 2025 |
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Step 1 Dose escalation / Step 2 Cohort expansion in two selected breast cancer sub-populations
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| Trastuzumab |
| Drug |
Trastuzumab solution for infusion administered weekly via IV |
|
| Fulvestrant | Drug | Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women) |
|
| Up to 3 years |
| Objective Response Rate (ORR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | ORR was calculated as the sum of the Best Overall Response (BOR) of complete response (CR) and partial response (PR) rates. ORR was defined according to Response Evaluation Criteria in Solid Tumors version 1.1assessment performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands). | Up to 3 years |
| Disease Control Rate (DCR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | DCR was defined as percentage of participants whose disease shrank or remained stable over a certain time period and was calculated as the sum of the best overall response (BOR) rates of CR, PR and Stable Disease (SD) rates. | Up to 3 years |
| Duration of Response (DOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | DOR was defined as time from first occurrence of a BOR of PR, CR or SD as locally assessed, until the disease has been shown to progress following treatment. Participants with a previous response who did not show a relapse or die without recording a relapse were censored at their last available relapse-free tumour assessment date. Participants with only one tumour assessment after baseline showing progressive disease (PD) were not included in the calculation. | Up to 3 years |
| Progression-free Survival (PFS) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | PFS was defined as the number of days between the first study treatment administration to the date of first documented disease progression as per local assessment, relapse or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last tumour assessment date. | Up to 3 years |
| Overall Survival (OS) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | OS was defined as the number of days between the first study treatment administration and death from any cause. Participants still alive who had withdrawn from the study were censored using the latest among end of study and follow-up dates. Drop-out participants were considered censored and the last available date in which the participant was known to be alive were used for calculation. | Up to 3 years |
| Farmington Hills |
| Michigan |
| 48334 |
| United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium |
| Institut Jules Bordet | Brussels | Belgium |
| UZ Leuven | Leuven | Belgium |
| Centre Georges François Leclerc | Dijon | France |
| Centre Oscar Lambret | Lille | France |
| Institut Régional du Cancer de Montpellier | Montferrier-sur-Lez | France |
| ICO - Site René Gauducheau | Saint-Herblain | France |
| Institut Claudius Regaud Oncopole | Toulouse | France |
| Institut Gustave Roussy | Villejuif | France |
| Azienda Ospedaliero Universitaria Mater Domini | Catanzaro | Italy |
| Istituto Clinico Humanitas | Milan | Italy |
| Istituto Europeo di Oncologia (IEO) | Milan | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Hospital Clínic i Provincial de Barcelona | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Centro Integral Oncologico Clara Campal | Madrid | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain |
| START Madrid Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Clínico Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Velindre Cancer Centre | Cardiff | United Kingdom |
| Sarah Cannon Research Institute UK | London | United Kingdom |
| University College London Hospitals | London | United Kingdom |
| The Christie | Manchester | United Kingdom |
Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
| FG002 | Dose Expansion Cohort | Participants received high dose of MEN1611 (Recommended Phase 2 dose [RP2D]) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
| Received At Least 1 Dose of Study Drug |
|
| DLT Population | DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment. |
|
| COMPLETED | Only deaths notified as leading to study discontinuation are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least 1 dose of MEN1611.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Escalation Cohort 1 | Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
| BG001 | Dose Escalation Cohort 2 | Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
| BG002 | Dose Expansion Cohort | Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | MTD of MEN1611 in Combination With Trastuzumab ± Fulvestrant | MTD was defined as the highest dose level at which no more than 1 participant experienced a DLT during the 28-day DLT assessment window. | DLT population included all participants from Dose Escalation Cohorts 1, 2 and 3 participants from the Dose Expansion Cohort. DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment. | Posted | Number | milligrams (mg) | Up to 28 Days |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With DLTs of MEN1611 in Combination With Trastuzumab ± Fulvestrant | DLT was defined as the occurrence of any of the protocol defined adverse drug reactions (ADRs) related to the combination regimens or to MEN1611 alone and unrelated to the participants' underlying disease or concomitant medication occurring during 28 days after the first MEN1611 administration. | DLT population included all participants from Dose Escalation Cohorts 1, 2 and 3 participants from the Dose Expansion Cohort. DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment. | Posted | Count of Participants | Participants | Up to 28 days |
| ||||||||||||||||||||||||||||
| Primary | RP2D of MEN1611 in Combination With Trastuzumab ± Fulvestrant | RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant experienced a DLT during the DLT assessment window (28days), or the maximum dose judged to be tolerable. | DLT population included all participants from Dose Escalation Cohorts 1, 2 and 3 participants from the Dose Expansion Cohort. DLT population consisted of all participants who received at least 80% of MEN1611 and 100% of trastuzumab and/or fulvestrant during 28 days after the first MEN1611 drug administration with a Safety Follow-up of 28 days after the first administration of the study treatment. | Posted | Number | mg | Up to 28 days |
|
| |||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | BOR was defined as percentage of participants who had a best overall response to therapy of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) and was defined according to Response Evaluation Criteria in Solid Tumors version 1.1 assessment locally performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands). | Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure. | Posted | Number | percentage of participants | Up to 3 years |
| ||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | ORR was calculated as the sum of the Best Overall Response (BOR) of complete response (CR) and partial response (PR) rates. ORR was defined according to Response Evaluation Criteria in Solid Tumors version 1.1assessment performed using computed tomography scans or magnetic resonance imaging of the chest and abdomen (including pelvis and adrenal glands). | Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
| |||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | DCR was defined as percentage of participants whose disease shrank or remained stable over a certain time period and was calculated as the sum of the best overall response (BOR) rates of CR, PR and Stable Disease (SD) rates. | Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | DOR was defined as time from first occurrence of a BOR of PR, CR or SD as locally assessed, until the disease has been shown to progress following treatment. Participants with a previous response who did not show a relapse or die without recording a relapse were censored at their last available relapse-free tumour assessment date. Participants with only one tumour assessment after baseline showing progressive disease (PD) were not included in the calculation. | Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | PFS was defined as the number of days between the first study treatment administration to the date of first documented disease progression as per local assessment, relapse or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last tumour assessment date. | Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) of MEN1611 in Combination With Trastuzumab ± Fulvestrant | OS was defined as the number of days between the first study treatment administration and death from any cause. Participants still alive who had withdrawn from the study were censored using the latest among end of study and follow-up dates. Drop-out participants were considered censored and the last available date in which the participant was known to be alive were used for calculation. | Efficacy Population included all eligible participants who received at least 8 weeks of any treatment and had at least 1 disease assessment. Here, 'Overall Number of Participants Analyzed' = participants who were evaluable for this Outcome Measure. | Posted | Median | 95% Confidence Interval | days | Up to 3 years |
|
Up to approximately 3 years
Safety Population included all participants who received at least 1 dose of MEN1611.
All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation are reported in the Participant Flow section.
Deaths that occurred during the follow-up after completion of the treatment period were collected for all cohorts.
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 | Dose Escalation Cohort 1 | Participants received low dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. | 3 | 3 | 2 | 3 | 2 | 3 |
| EG001 | Dose Escalation Cohort 2 | Participants received medium dose of MEN1611 twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. | 3 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Dose Expansion Cohort | Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. | 28 | 56 | 21 | 56 | 56 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Brachial plexopathy | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Blepharitis | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry eye | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Xerophthalmia | Cardiac disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Discoloured vomit | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Temperature regulation disorder | General disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (25.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (25.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vulvovaginal inflammation | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (25.1) | Systematic Assessment |
|
The results of the study cannot be submitted for presentation, abstract, poster exhibition, or publication by the investigator until Menarini Ricerche S.p.A. has reviewed/commented and agreed to any publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Sciences | Menarini Ricerche S.p.A. | +39 05556809990 | martine.piccart@bordet.be |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2023 | Feb 18, 2025 | 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 |
|---|---|
| D000068878 | Trastuzumab |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown |
|
Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
|
|
|
Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
|
|
Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
|
|
|
|
Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks. |
|
|
|
|
Participants received high dose of MEN1611 (RP2D) twice daily administered in combination with trastuzumab once every 3 weeks ± fulvestrant once every 4 weeks.
|
|