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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002018-36 | EudraCT Number | EudraCT |
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The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBW 2992 | Experimental | high dose once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | high dose once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) | OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Clinical Benefit (CB) | CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit (CB) | CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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Inclusion criteria:
Inclusion Criteria:
Exclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.10.3201 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||||
| 1200.10.3208 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) |
| FG001 | Cohort B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Time to OR | The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Duration of OR | Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Progression-free Survival (PFS) | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates. | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
| Overall Survival (OS) | OS is defined as time from randomisation to death. | From randomisation to end of follow-up. |
| Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF) | LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent. | Baseline and last assessment |
| Best Change From Baseline in ECOG Performance Status | Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). | baseline till end of treatment |
| Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29) | Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29. | day 29 |
| Brussels |
| Belgium |
| 1200.10.3203 Boehringer Ingelheim Investigational Site | Charleroi | Belgium |
| 1200.10.3205 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| 1200.10.3204 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1200.10.3206 Boehringer Ingelheim Investigational Site | Wilrijk | Belgium |
| 1200.10.49005 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1200.10.49007 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1200.10.49008 Boehringer Ingelheim Investigational Site | Erlangen | Germany |
| 1200.10.49010 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1200.10.49003 Boehringer Ingelheim Investigational Site | Kiel | Germany |
| 1200.10.49004 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1200.10.49001 Boehringer Ingelheim Investigational Site | München | Germany |
| 1200.10.49006 Boehringer Ingelheim Investigational Site | Wiesbaden | Germany |
Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) |
| BG001 | Cohort B | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| 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 |
| |||||||||||||||
| Sex: Female, Male | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Clinical Benefit (CB) | CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A. | TS. No data for Cohort A as CB was secondary endpoint only for Cohort B. | Posted | Number | Participants with CB | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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| Secondary | Time to OR | The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria. | TS. Median time to OR was not calcuable as there was no OR observed. | Posted | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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| Secondary | Duration of OR | Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented. | TS. Median duration of OR was not calcuable as there was no OR observed. | Posted | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates. | TS | Posted | Median | 95% Confidence Interval | days | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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| Primary | Objective Response (OR) | OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B. | Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B. | Posted | Number | Participants with OR | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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| Primary | Clinical Benefit (CB) | CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A. | TS. No data for Cohort B as CB was primary endpoint only for Cohort A. | Posted | Number | Participants | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
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| Secondary | Overall Survival (OS) | OS is defined as time from randomisation to death. | TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A. | Posted | Median | 95% Confidence Interval | days | From randomisation to end of follow-up. |
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| Secondary | Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF) | LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent. | TS | Posted | Number | Participants | Baseline and last assessment |
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| Secondary | Best Change From Baseline in ECOG Performance Status | Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). | Posted | Number | participants | baseline till end of treatment |
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| Secondary | Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29) | Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | day 29 |
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First administration of trial medication until 28 days after last administration of trial medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | 13 | 29 | 28 | 29 | ||
| EG001 | Cohort B | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd | 7 | 21 | 20 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Meniere's disease | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
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| Eyelid ptosis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| Miosis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Abscess rupture | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| VIth nerve paralysis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| 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 |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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