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This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.
Approximately 105 subjects will be enrolled in the study and randomized 2:1 to one of the following regimens Arm A (n=70): Lapatinib 1250 mg orally once daily continuously plus Vinorelbine 20mg/m2 intravenously (IV) on day 1 and 8, every third week, or Arm B (n=35): Lapatinib 1250 mg orally once daily (QD) continuously plus Capecitabine 2000 mg/m2/day orally in 2 doses 12 hours apart on days 1-14 every third week. Randomization will be stratified according to the following variables: 1) Prior receipt of therapy for metastatic breast cancer (Yes or No), and 2) Site of metastatic disease (Visceral/Soft tissue or Bone-only). Subjects will receive randomized study treatment until disease progression or discontinuation of study treatment due to unacceptable toxicity, withdrawal of consent, lost to follow up, or death. All subjects who discontinue study treatment without documented progression will continue to be followed for progression according to protocol-schedule until new anti-cancer therapy is initiated and/or progression or death is documented. Survival data will be collected for all subjects to ensure a minimum of 18 months survival data. This study will include a safety run-in phase for approximately the first 30 subjects (20 randomized to lapatinib and vinorelbine; 10 to lapatinib and capecitabine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lapatinib + Vinorelbine | Experimental | Lapatinib + Vinorelbine |
|
| Lapatinib + Capecitabine | Active Comparator | Lapatinib + Capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine | Drug | Vinorelbine |
| |
| Lapatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) in the Randomized Phase | PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion. | From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase | OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR. |
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Inclusion Criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Plovdiv | 4000 | Bulgaria | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34037241 | Derived | Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. | |
| 26384789 | Derived | Janni W, Sarosiek T, Karaszewska B, Pikiel J, Staroslawska E, Potemski P, Salat C, Brain E, Caglevic C, Briggs K, Mahood K, DeSilvio M, Marini L, Papadimitriou C. Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer. Breast. 2015 Dec;24(6):769-73. doi: 10.1016/j.breast.2015.08.005. Epub 2015 Sep 16. |
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In the Randomized Phase (RP), participants were treated until disease progression (PD) or discontinuation of treatment due to unacceptable toxicity, withdrawal of consent, lost to follow-up, or death. After PD in the RP, participants were given the option of crossing over to the alternative treatment arm in a post-progression Cross-over Phase (CP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP | Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
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| Drug |
Lapatinib |
|
| Capecitabine | Drug | Capecitabine |
|
| From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) |
| Overall Survival (OS) | OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off. | From the date of randomization until death (average of 55 study weeks) |
| Duration of Response (DOR) in the Randomized Phase | DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD. | From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks) |
| Time to Response in the Randomized Phase | Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed. | From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks) |
| Number of Participants With Clinical Benefit (CB) in the Randomized Phase | CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders. | From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) |
| Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine | AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available. | Days 1 and 8; 0 to 24 hours post-dose |
| Maximum Concentration (Cmax) for Vinorelbine | Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available. | Days 1 and 8; 0 to 24 hours post-dose |
| Number of Participants With Grade 4 and Grade 5 Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE. | From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks) |
| Sofia |
| 1527 |
| Bulgaria |
| Novartis Investigative Site | Sofia | 1756 | Bulgaria |
| Novartis Investigative Site | Varna | 9010 | Bulgaria |
| Novartis Investigative Site | Santiago | Región Metro de Santiago | 750 1088 | Chile |
| Novartis Investigative Site | Santiago | Región Metro de Santiago | 7650635 | Chile |
| Novartis Investigative Site | Viña Del Mar | ValparaÃ-so | 2520612 | Chile |
| Novartis Investigative Site | Bayonne | 64100 | France |
| Novartis Investigative Site | Marseille | 13009 | France |
| Novartis Investigative Site | Nîmes Cedex 9 | 30029 | France |
| Novartis Investigative Site | Saint-Cloud | 92210 | France |
| Novartis Investigative Site | Rheinfelden | Baden-Wurttemberg | 79618 | Germany |
| Novartis Investigative Site | München | Bavaria | 80638 | Germany |
| Novartis Investigative Site | Munich | Bavaria | 80337 | Germany |
| Novartis Investigative Site | Bad Nauheim | Hesse | 61231 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60590 | Germany |
| Novartis Investigative Site | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Novartis Investigative Site | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
| Novartis Investigative Site | Velbert | North Rhine-Westphalia | 42551 | Germany |
| Novartis Investigative Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Novartis Investigative Site | Chemnitz | Saxony | 09116 | Germany |
| Novartis Investigative Site | Berlin | State of Berlin | 12200 | Germany |
| Novartis Investigative Site | Athens | 115 22 | Greece |
| Novartis Investigative Site | Athens | 115 28 | Greece |
| Novartis Investigative Site | Heraklion,Crete | 71110 | Greece |
| Novartis Investigative Site | Thessaloniki | 564 29 | Greece |
| Novartis Investigative Site | Brindisi | Apulia | 72100 | Italy |
| Novartis Investigative Site | Genoa | Liguria | 16132 | Italy |
| Novartis Investigative Site | Brescia | Lombardy | 25124 | Italy |
| Novartis Investigative Site | Turin | Piedmont | 10126 | Italy |
| Novartis Investigative Site | Catania | Sicily | 95124 | Italy |
| Novartis Investigative Site | Catania | Sicily | Italy |
| Novartis Investigative Site | Ancona | The Marches | 60020 | Italy |
| Novartis Investigative Site | Verona | Veneto | 37135 | Italy |
| Novartis Investigative Site | Monterrey | Nuevo León | 64060 | Mexico |
| Novartis Investigative Site | Oaxaca City | Oaxaca | 68000 | Mexico |
| Novartis Investigative Site | Gdansk | 80-219 | Poland |
| Novartis Investigative Site | Gliwice | 44-101 | Poland |
| Novartis Investigative Site | Konin | 62-500 | Poland |
| Novartis Investigative Site | Lodz | 93-509 | Poland |
| Novartis Investigative Site | Lublin | 20-090 | Poland |
| Novartis Investigative Site | Olsztyn | 10-513 | Poland |
| Novartis Investigative Site | Warsaw | 04-125 | Poland |
| Novartis Investigative Site | Belgrade | Serbia |
| Novartis Investigative Site | Kamenitz | 21204 | Serbia |
| Novartis Investigative Site | Fuenlabrada (Madrid) | 28942 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | Marbella | 29600 | Spain |
| Novartis Investigative Site | Pamplona | 31008 | Spain |
| Novartis Investigative Site | Reus | 43201 | Spain |
| Novartis Investigative Site | Segovia | 40002 | Spain |
| Novartis Investigative Site | Vigo (Pontevedra) | 36204 | Spain |
| Novartis Investigative Site | Zamora | Spain |
| FG001 | Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP | Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase. |
| Ongoing |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP | Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase. |
| BG001 | Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP | Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, 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 | Progression Free Survival (PFS) in the Randomized Phase | PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion. | ITT Population: participants who were randomized to study treatment, regardless of whether they actually received study medication | Posted | Median | 95% Confidence Interval | months | From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) |
|
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|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase | OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR. | ITT Population | Posted | Number | participants | From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off. | ITT Population | Posted | Median | 95% Confidence Interval | months | From the date of randomization until death (average of 55 study weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in the Randomized Phase | DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD. | ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response. | Posted | Median | 95% Confidence Interval | months | From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks) |
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| Secondary | Time to Response in the Randomized Phase | Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed. | ITT Population. Only participants with a confirmed CR or PR were assessed for time to response. | Posted | Median | 95% Confidence Interval | weeks | From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks) |
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| Secondary | Number of Participants With Clinical Benefit (CB) in the Randomized Phase | CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders. | ITT Population | Posted | Number | participants | From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks) |
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| Secondary | Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine | AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available. | Posted | Days 1 and 8; 0 to 24 hours post-dose |
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| Secondary | Maximum Concentration (Cmax) for Vinorelbine | Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available. | Posted | Days 1 and 8; 0 to 24 hours post-dose |
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| Secondary | Number of Participants With Grade 4 and Grade 5 Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE. | Safety Population: participants who received at least one dose of study medication, based on the actual treatment received | Posted | Number | participants | From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks) |
|
Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV. Initiation Date: 25 November 2009- Completion Date: 21 August 2012
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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 | Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2 | Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2 | 4 | 37 | 32 | 37 | ||
| EG001 | Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2 | Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2 | 25 | 75 | 72 | 75 | ||
| EG002 | Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2 | Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2 | 3 | 37 | 27 | 37 | ||
| EG003 | Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2 | Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2 | 4 | 17 | 15 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Device leakage | Product Issues | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ophthalmoplegia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| D000077341 | Lapatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011799 | Quinazolines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Native Hawaiian or other Pacific Islander & White |
|
| African American/African Heritage |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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|
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|
|
Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
|
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| Units |
|---|
| Counts |
|---|
| Participants |
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