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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003432-22 | EudraCT Number | ||
| CLAP016A2301 | Other Identifier | Novartis |
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Enrollment was closed after the open label stage due to poor recruitment rate (randomized stage never opened).
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This study was originally designed as a Phase III randomized, double blind, placebo controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic breast cancer. The planned study was a two stage design with an initial open-label safety stage to be conducted in approximately 65 subjects followed by a randomized phase conducted in a further 700 subjects. The open-label part of the study sequentially enrolled three cohorts with patients receiving a different dose combination of paclitaxel, trastuzumab and lapatinib. Following poor recruitment rate in the open label stage, the randomized stage of the study was terminated, thus no subjects were enrolled into the randomization stage.
The primary objective of this study was to evaluate and compare time to progression (TTP). The Primary objective for open label phase was to determine the safety and tolerability of lapatinib when administered in combination with both paclitaxel and trastuzumab. The study first enrolled an open label safety cohort of 20 patients to assess the tolerability of the triplet combination. This was a 1 arm, 3 cohort study stage.
Open-label Phase: Patients were sequentially enrolled into three cohorts and received an open-label combination of paclitaxel, trastuzumab and lapatinib: Cohort 1 received paclitaxel 80mg/m2 IV weekly for 3 weeks of a 4 week cycle, trastuzumab 4 mg/kg IV loading dose and 2 mg/kg IV weekly, and lapatinib 1000 mg PO daily. Cohort 2 received paclitaxel 70mg/m2 IV weekly for 3 weeks of a 4 week cycle, trastuzumab 4 mg/kg IV loading dose and 2 mg/kg IV weekly, and lapatinib 1000 mg PO daily. Cohort 3 paclitaxel 80mg/m2 IV weekly for 3 weeks of a 4 week cycle, trastuzumab 4 mg/kg IV loading dose and 2 mg/kg IV weekly, and lapatinib 750 mg PO daily.
Randomized Phase: was terminated following the poor recruitment rate in the open-label safety stage. No subjects were enrolled into the randomization stage.
In summary, at approximately 3.5 years the primary analysis which included demographics, efficacy and safety were conducted; at approximately 7 years protocol amendment 7 cancelled collection of efficacy endpoints, and only key safety endpoints were to be collected; the final analysis was performed at approximately 14 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants received: paclitaxel 80mg/m2 IV weekly for 3 weeks of a 4 week cycle plus trastuzumab 4 mg/kg IV loading dose and 2 mg/kg IV weekly plus lapatinib 1000 mg PO daily |
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| Cohort 2 | Experimental | Participants received paclitaxel 70mg/m2 IV weekly for 3 weeks of a 4 week cycle plus trastuzumab 4 mg/kg IV loading dose and 2 mg/kg IV weekly plus lapatinib 1000 mg PO daily. |
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| Cohort 3 | Experimental | Participants in this arm received 80mg/m2 IV weekly for 3 weeks of a 4 week cycle plus trastuzumab 4 mg/kg IV loading dose and 2 mg/kg IV weekly plus lapatinib 750 mg PO |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib | Drug | (GW572016) 1000 mg QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Mean/Standard Deviation | Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment. | From the date of the first dose of the investigational product to end of study, up to approx. 14 years |
| Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Median/Min-Max | Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment. | From the date of the first dose of the investigational product to end of study, up to approx. 14 years |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 14 years |
| Number of Participants Who Died Due to Any Cause | Number of participants who died due to any cause throughout the study including off-treatment deaths (on-treatment deaths are reported for the All-Cause Mortality in the AE section). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response as Assessed by the Investigator | Time to Response was defined for subjects who had a confirmed CR or PR as the time from first dose until first documented evidence of partial or complete tumour response (whichever status was recorded first). CR is defined as the disappearance of all TLs & non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. |
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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 | Roswell | Georgia | 30076 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23697602 | Background | Esteva FJ, Franco SX, Hagan MK, Brewster AM, Somer RA, Williams W, Florance AM, Turner S, Stein S, Perez A. An open-label safety study of lapatinib plus trastuzumab plus paclitaxel in first-line HER2-positive metastatic breast cancer. Oncologist. 2013 Jun;18(6):661-6. doi: 10.1634/theoncologist.2012-0129. Epub 2013 May 22. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Participants who met inclusion criteria were sequentially enrolled into three cohorts and received the open-label triple combination of paclitaxel, trastuzumab and lapatinib. The planned randomized phase of the study was terminated following the poor recruitment rate in the Open-label Phase.
Female participants (par.) with histologically confirmed invasive breast cancer (Stage IV disease) whose tumors overexpressed the ErbB2 protein, documented by either Immunohistochemistry (IHC) or fluorescence in situ hybridisation (FISH), were eligible for inclusion in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| paclitaxel |
| Drug |
80 mg/m2 IV weekly for three weeks |
|
| trastuzumab | Drug | 4 mg/kg loading dose and 2 mg/kg weekly IV |
|
| From the date of the first dose of investigational product until last patient last visit, up to approximately 14 years |
| Number of Events of Diarrhea With the Indicated Characteristics | Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category. | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years |
| Number of Events of Rash With the Indicated Characteristics | Events of rash are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category. | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years |
| Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters | Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters | Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values > upper limit of normal (ULN)=Hyper; values < lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if >2 milligram per deciliter [mg/dL]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is > twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Number of Events of Hepatotoxicity With the Indicated Characteristics | Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category. | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Change From Baseline in Heart Rate at the Indicated Time Points | Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Change From Baseline in Body Temperature at the Indicated Time Points | Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Number of Participants With at Least 1 Event of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics | Events of left ventricular ejection fraction (LVEF) decrease were based on the number of participants who had an actual event and was characterized as serious, related to investigational product, leading to withdrawal from the study and/or fatal. | Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value | The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| Number of Participants Who Received Any Concomitant Medications During the Study Period | Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period. | withdrawal/study completion, up to approx. 3.5 years |
| Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator | OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders. | From the date of the first dose of investigational product to end of study, up to approx. 7 years |
| From the date of the first dose of investigational product until the first documented evidence of a PR or CR, up to approx. 7 years |
| Duration of Response (DoR), as Assessed by the Investigator | DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment. | From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer, up to approx. 7 years |
| Percentage of Participants With Clinical Benefit (Complete Response (CR), Partial Response (PR), and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator | Clinical benefit is defined as the percentage of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (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 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit. | From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer, up to approx. 7 years |
| Progression-free Survival as Assessed by the Investigator | Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves. | From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause, up to approx. 7 years |
| Joliet |
| Illinois |
| 60435 |
| United States |
| Novartis Investigative Site | Detroit | Michigan | 48202 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39202 | United States |
| Novartis Investigative Site | Voorhees Township | New Jersey | 08043 | United States |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Novartis Investigative Site | Canton | Ohio | 44718 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43219 | United States |
| Novartis Investigative Site | Middletown | Ohio | 45042 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29406 | United States |
| Novartis Investigative Site | Amarillo | Texas | 79106 | United States |
| Novartis Investigative Site | Houston | Texas | 77030-4009 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23230 | United States |
| Novartis Investigative Site | Arlon | 6700 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| FG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| FG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. |
| BG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| BG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
| BG003 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | |||||||||||||||||||||||||||
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| Primary | Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Mean/Standard Deviation | Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment. | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Mean | Standard Deviation | Weeks | From the date of the first dose of the investigational product to end of study, up to approx. 14 years |
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| Primary | Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Median/Min-Max | Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment. | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Median | Full Range | Weeks | From the date of the first dose of the investigational product to end of study, up to approx. 14 years |
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| Primary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Number | Participants | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 14 years |
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| Primary | Number of Participants Who Died Due to Any Cause | Number of participants who died due to any cause throughout the study including off-treatment deaths (on-treatment deaths are reported for the All-Cause Mortality in the AE section). | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Number | Participants | From the date of the first dose of investigational product until last patient last visit, up to approximately 14 years |
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| Primary | Number of Events of Diarrhea With the Indicated Characteristics | Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category. | Safety Population. Only the participants with at least one event of diarrhea were analyzed. | Posted | Number | Events of diarrhea | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years |
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| Primary | Number of Events of Rash With the Indicated Characteristics | Events of rash are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category. | Safety Population. Only the participants with at least one event of rash were analyzed. | Posted | Number | Events of rash | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years |
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| Primary | Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters | Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Number | Participants | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
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| Primary | Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters | Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values > upper limit of normal (ULN)=Hyper; values < lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if >2 milligram per deciliter [mg/dL]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is > twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
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| Primary | Number of Events of Hepatotoxicity With the Indicated Characteristics | Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category. | Safety Population. Only the participants with at least one of event of hepatotoxicity were analyzed. | Posted | Number | Events of hepatotoxicity | From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years |
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| Primary | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points | Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
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| Primary | Change From Baseline in Heart Rate at the Indicated Time Points | Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute (BPM) | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
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| Primary | Change From Baseline in Body Temperature at the Indicated Time Points | Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants available at the specified time points were analyzed | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
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| Primary | Number of Participants With at Least 1 Event of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics | Events of left ventricular ejection fraction (LVEF) decrease were based on the number of participants who had an actual event and was characterized as serious, related to investigational product, leading to withdrawal from the study and/or fatal. | Safety Population. Only the participants with at least one of event of LVEF decrease were analyzed. | Posted | Number | Participants | Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value | The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population. | Posted | Number | Participants | Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Received Any Concomitant Medications During the Study Period | Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period. | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Number | Participants | withdrawal/study completion, up to approx. 3.5 years |
| |||||||||||||||||||||||||||||||||||
| Primary | Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator | OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders. | Safety Population: all participants who were randomized and received at least one dose of investigational product. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of the first dose of investigational product to end of study, up to approx. 7 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Response as Assessed by the Investigator | Time to Response was defined for subjects who had a confirmed CR or PR as the time from first dose until first documented evidence of partial or complete tumour response (whichever status was recorded first). CR is defined as the disappearance of all TLs & non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. | Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR or PR were analyzed. | Posted | Number | Participants | From the date of the first dose of investigational product until the first documented evidence of a PR or CR, up to approx. 7 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR), as Assessed by the Investigator | DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment. | Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR or PR were analyzed. | Posted | Median | Inter-Quartile Range | Weeks | From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer, up to approx. 7 years |
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| Secondary | Percentage of Participants With Clinical Benefit (Complete Response (CR), Partial Response (PR), and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator | Clinical benefit is defined as the percentage of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (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 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit. | Safety Population. Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR, PR and SD for at least 24 weeks were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer, up to approx. 7 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival as Assessed by the Investigator | Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves. | Safety Population: all participants who were randomized and received at least one dose of investigational product. Only those participants with CR, PR and SD for at least 24 weeks were analyzed. | Posted | Median | 95% Confidence Interval | Weeks | From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause, up to approx. 7 years |
|
Adverse Events (AEs) and Serious adverse events (SAEs) were collected from the first dose of investigational product to 30 days after the last dose of investigational product, up to approx.12 years (maximum exposure to Lapatinib (615 weeks) plus 30 days.
AEs and SAEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product, according to the actual treatment received.
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 | Cohort 1: Paclitaxel 80mg/Trastuzumab 4 mg/Lapatinib 1000mg | Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. | 0 | 29 | 14 | 29 | 29 | 29 |
| EG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. | 0 | 14 | 6 | 14 | 13 | 14 |
| EG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. | 0 | 20 | 5 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small 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 |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue 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 |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | 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 |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal 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 |
| |
| Cheilitis | 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 |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angular cheilitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis viral | 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 |
| |
| Laryngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | 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 creatinine increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | 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 |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypophosphataemia | 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 |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal 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 |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoaesthesia | 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 |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Toxic neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal discharge | 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 |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mastectomy | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Prophylaxis | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphoedema | 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 |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| White - White/Caucasian/European Heritage |
|
|
| Paclitaxel |
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG001 |
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg |
Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| OG001 | Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg |
Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (total daily dose 1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated. |
| OG002 | Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (total daily dose 750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated. |
|
|