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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024454-10 | EudraCT Number | EudraCT |
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The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include patients who have and have not failed prior trastuzumab treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afatinib once daily (OD) | Experimental | Patients receive afatinib monotherapy once daily until progression of their disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afatinib once daily (OD) | Drug | Patient to receive afatinib monotherapy until progression of their disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). | This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. |
| Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). | This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Objective response was defined on a patient level as a best response of CR or PR. | This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1200.89.10001 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |||
| 1200.89.10005 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27923043 | Derived | Goh G, Schmid R, Guiver K, Arpornwirat W, Chitapanarux I, Ganju V, Im SA, Kim SB, Dechaphunkul A, Maneechavakajorn J, Spector N, Yau T, Afrit M, Ahmed SB, Johnston SR, Gibson N, Uttenreuther-Fischer M, Herrero J, Swanton C. Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine. PLoS Med. 2016 Dec 6;13(12):e1002136. doi: 10.1371/journal.pmed.1002136. eCollection 2016 Dec. |
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Part A: Patients were treated with Afatinib and could continue on treatment until first Progression of Disease (PD), intolerable side effects, or withdrawal of consent. Upon first PD, patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with weekly Vinorelbine.
This was an open-label study conducted in two sequential parts (Part A in which patients were treated with Afatinib (BIBW 2992) as monotherapy; Part B in which patients were treated with Afatinib plus Vinorelbine as combination therapy after progression on Afatinib monotherapy).
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| ID | Title | Description |
|---|---|---|
| FG000 | Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B). | Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
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| Vinorelbine Weekly | Drug | Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy |
|
| Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Objective response was defined on a patient level as a best response of CR or PR. | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days. |
| Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Objective response was defined on a patient level as a best response of CR or PR. | This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. |
| Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). | Objective response was defined on a patient level as a best response of CR or PR. | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. |
| Part A: Duration of Unconfirmed Objective Response. | Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)). | From first drug administration until end of Part A, up to 929 days. |
| Part B: Duration of Unconfirmed Objective Response. | Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS). | From first drug administration until end of Part B, up to 929 days. |
| Part A: Progression Free Survival. | PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A. | From first drug administration until end of Part A, up to 713 days. |
| Part B: Progression Free Survival. | PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B. | From first drug administration until end of Part B, up to 230 days. |
| Progression Free Survival Over the Whole Sudy. | PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD. | From first drug administration until end of study, up to 700 days. |
| Durham |
| North Carolina |
| United States |
| 1200.89.61002 Boehringer Ingelheim Investigational Site | East Bentleigh | Victoria | Australia |
| 1200.89.61003 Boehringer Ingelheim Investigational Site | Perth | Western Australia | Australia |
| 1200.89.85201 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong |
| 1200.89.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1200.89.82002 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1200.89.66002 Boehringer Ingelheim Investigational Site | Bangkok | Thailand |
| 1200.89.66004 Boehringer Ingelheim Investigational Site | Bangkok | Thailand |
| 1200.89.66003 Boehringer Ingelheim Investigational Site | Chiang Mai | Thailand |
| 1200.89.66001 Boehringer Ingelheim Investigational Site | Hat-Yai, Songkhla | Thailand |
| 1200.89.21601 Boehringer Ingelheim Investigational Site | Aryanah | Tunisia |
| 1200.89.21602 Boehringer Ingelheim Investigational Site | Sousse | Tunisia |
| 1200.89.44002 Boehringer Ingelheim Investigational Site | Bournemouth | United Kingdom |
| 1200.89.44001 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1200.89.44003 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B |
|
|
TRT A Treated set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.
TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine). | Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | 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 | Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Posted | Number | 95% Confidence Interval | Percentage of participants | This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. |
|
|
| |||||||||||||||||||||||||
| Primary | Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Posted | Number | 95% Confidence Interval | Percentage of participants | This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. |
| |||||||||||||||||||||||||||
| Secondary | Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Objective response was defined on a patient level as a best response of CR or PR. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Posted | Number | 95% Confidence Interval | Percentage of participants | This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Objective response was defined on a patient level as a best response of CR or PR. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Posted | Number | 95% Confidence Interval | Percentage of participants | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1). | Objective response was defined on a patient level as a best response of CR or PR. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Posted | Number | 95% Confidence Interval | Percentage of participants | This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ). | Objective response was defined on a patient level as a best response of CR or PR. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Posted | Number | 95% Confidence Interval | Percentage of participants | This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part A: Duration of Unconfirmed Objective Response. | Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)). | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Posted | Median | 95% Confidence Interval | Days | From first drug administration until end of Part A, up to 929 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Duration of Unconfirmed Objective Response. | Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS). | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Posted | Median | 95% Confidence Interval | Days | From first drug administration until end of Part B, up to 929 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part A: Progression Free Survival. | PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. | Posted | Median | 95% Confidence Interval | Days | From first drug administration until end of Part A, up to 713 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Part B: Progression Free Survival. | PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B. | TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Posted | Median | 95% Confidence Interval | Days | From first drug administration until end of Part B, up to 230 days. |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival Over the Whole Sudy. | PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD. | TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A. TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B. | Posted | Median | 95% Confidence Interval | Days | From first drug administration until end of study, up to 700 days. |
|
|
Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
The additional 28 days is the residual effect period which was added to the last study drug administration in each part. This may have been truncated in Part A where patients started Vinorelbine prior to the 28 days elapsing.
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 | Part A: Afatinib Once Daily (OD). | Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. | 12 | 26 | 26 | 26 | ||
| EG001 | Part B: Afatinib+V (Vinorelbine). | Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. | 4 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Panophthalmitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fungating wound | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) decided to stop further inclusion of patients and stop further treatment with the combination of Afatinib and Vinorelbine as of 03-May-2013. Recruitment into the trial was stopped by amendment in Jul 2013.
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 Call Center | Boehringer Ingelheim (BI) | 1800-243-0127 | 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 |
Not provided
Not provided
| Male (Part A) |
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| Male (Part B) |
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