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Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Chemotherapy plus trastuzumab |
|
| Arm B | Experimental | Chemotherapy plus lapatinib |
|
| Arm C | Active Comparator | Chemotherapy plus trastuzumab plus lapatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib | Drug | Arm B 1250mg/d PO Arm C 750mg/d PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes | Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery. | At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography | The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value. |
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Inclusion criteria:
HER2 positive tumor (either IHC 3+ or FISH+)
leukocytes ³ 3000/microL
absolute neutrophil count ³ 1,500/microL
platelets ³ 100,000/microL
total bilirubin <= 1.5x ULN. In case of Gilbert's syndrome, <2 x ULN is allowed
AST (SGOT)/ALT(SGPT)<= 2.5 X institutional upper limit of normal
Alkaline phosphatase <= 2.5 x ULN
Creatinine within normal institutional limits
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Berlin | State of Berlin | 13125 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22493419 | Background | Guarneri V, Frassoldati A, Bottini A, Cagossi K, Bisagni G, Sarti S, Ravaioli A, Cavanna L, Giardina G, Musolino A, Untch M, Orlando L, Artioli F, Boni C, Generali DG, Serra P, Bagnalasta M, Marini L, Piacentini F, D'Amico R, Conte P. Preoperative chemotherapy plus trastuzumab, lapatinib, or both in human epidermal growth factor receptor 2-positive operable breast cancer: results of the randomized phase II CHER-LOB study. J Clin Oncol. 2012 Jun 1;30(16):1989-95. doi: 10.1200/JCO.2011.39.0823. Epub 2012 Apr 9. | |
| 34153715 |
Not provided
Not provided
Participants underwent core biopsy of the primary tumor, for the histological diagnosis and the biological characterization of the tumor. Radiological investigations were performed to rule out the metastatic disease. After diagnostic confirmation of the infiltrating carcinoma, participants were randomized to one of the three treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy (CT) Plus Trastuzumab | Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| trastuzumab | Biological | First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins |
|
|
| paclitaxel | Drug | 80mg/sqm 1 hour infusion for 12 weeks |
|
|
| fluorouracil | Drug | 600mg/sqm iv day 1 q21 days for four coursess |
|
| epidoxorubicin | Drug | 75mg/sqm iv day 1 q21 days for four courses |
|
| cyclophosphamide | Drug | 600mg/sqm day 1 q21 days for four courses |
|
| At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27) |
| Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS | The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported. | At Baseline and at surgery (up to Study Week 29) |
| Time to Treatment Failure From the Start of Primary Therapy | Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments. | From randomization up to Study Week 307 |
| Number of Participants With Treatment Failure | Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause. | From randomization up to 29 weeks |
| Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment | The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal). | At Baseline and Withdrawal (assessed up to Study Week 29) |
| Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants | 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 had been exercised in deciding whether reporting was appropriate in other situations. | From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29) |
| Number of Variations/Somatic Mutation in PI3KCA at Baseline | Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots). | Baseline |
| Brindisi |
| Apulia |
| 72100 |
| Italy |
| GSK Investigational Site | Carpi (MO) | Emilia-Romagna | 41012 | Italy |
| GSK Investigational Site | Forlì | Emilia-Romagna | 47100 | Italy |
| GSK Investigational Site | Modena | Emilia-Romagna | 41100 | Italy |
| GSK Investigational Site | Parma | Emilia-Romagna | 43100 | Italy |
| GSK Investigational Site | Piacenza | Emilia-Romagna | 29100 | Italy |
| GSK Investigational Site | Rimini | Emilia-Romagna | 47900 | Italy |
| GSK Investigational Site | Treviglio (BG) | Lombardy | 24047 | Italy |
| GSK Investigational Site | Candiolo (TO) | Piedmont | 10060 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56126 | Italy |
| GSK Investigational Site | Cremona | 26100 | Italy |
| GSK Investigational Site | Pavia | 27100 | Italy |
| GSK Investigational Site | Perugia | 06156 | Italy |
| GSK Investigational Site | Reggio Emilia | 42100 | Italy |
| GSK Investigational Site | Varese | 21100 | Italy |
| GSK Investigational Site | Warsaw | 00-909 | Poland |
| Derived |
| Guarneri V, Dieci MV, Griguolo G, Miglietta F, Girardi F, Bisagni G, Generali DG, Cagossi K, Sarti S, Frassoldati A, Gianni L, Cavanna L, Pinotti G, Musolino A, Piacentini F, Cinieri S, Prat A, Conte P; of the CHER-Lob study team. Trastuzumab-lapatinib as neoadjuvant therapy for HER2-positive early breast cancer: Survival analyses of the CHER-Lob trial. Eur J Cancer. 2021 Aug;153:133-141. doi: 10.1016/j.ejca.2021.05.018. Epub 2021 Jun 19. |
| 26245675 | Derived | Guarneri V, Dieci MV, Frassoldati A, Maiorana A, Ficarra G, Bettelli S, Tagliafico E, Bicciato S, Generali DG, Cagossi K, Bisagni G, Sarti S, Musolino A, Ellis C, Crescenzo R, Conte P. Prospective Biomarker Analysis of the Randomized CHER-LOB Study Evaluating the Dual Anti-HER2 Treatment With Trastuzumab and Lapatinib Plus Chemotherapy as Neoadjuvant Therapy for HER2-Positive Breast Cancer. Oncologist. 2015 Sep;20(9):1001-10. doi: 10.1634/theoncologist.2015-0138. Epub 2015 Aug 5. |
| 24590635 | Derived | Guarneri V, Generali DG, Frassoldati A, Artioli F, Boni C, Cavanna L, Tagliafico E, Maiorana A, Bottini A, Cagossi K, Bisagni G, Piacentini F, Ficarra G, Bettelli S, Roncaglia E, Nuzzo S, Swaby R, Ellis C, Holford C, Conte P. Double-blind, placebo-controlled, multicenter, randomized, phase IIb neoadjuvant study of letrozole-lapatinib in postmenopausal hormone receptor-positive, human epidermal growth factor receptor 2-negative, operable breast cancer. J Clin Oncol. 2014 Apr 1;32(10):1050-7. doi: 10.1200/JCO.2013.51.4737. Epub 2014 Mar 3. |
| FG001 | CT Plus Lapatinib 1500 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. |
| FG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CT Plus Trastuzumab | Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery. |
| BG001 | CT Plus Lapatinib 1500 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. |
| BG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | 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 | Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes | Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery. | Efficacy Analysis Population: all participants in the Intent-to-Treat Population (all participants who were randomized), except for the 2 participants who were excluded because of withdraw of consent and major protocol deviation | Posted | Number | Percentage of participants | At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography | The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value. | Efficacy Analysis Population | Posted | Number | Percentage of participants | At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS | The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported. | Efficacy Analysis Population | Posted | Number | Percentage of participants | At Baseline and at surgery (up to Study Week 29) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure From the Start of Primary Therapy | Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments. | ITT Population: all participants who were randomized | Posted | Median | 95% Confidence Interval | Months | From randomization up to Study Week 307 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Failure | Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause. | ITT Population | Posted | Number | Participants | From randomization up to 29 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment | The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal). | ITT Population. Only those participants contributing data to the indicated time points were analyzed. | Posted | Median | Full Range | Percentage of inhibition | At Baseline and Withdrawal (assessed up to Study Week 29) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants | 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 had been exercised in deciding whether reporting was appropriate in other situations. | Safety Population: all randomized participants | Posted | Number | Participants | From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Variations/Somatic Mutation in PI3KCA at Baseline | Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots). | ITT Population. Only those participants for which high-quality tumor tissue samples were available were analyzed. | Posted | Number | Variations/Somatic mutations | Baseline |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of randomized therapy to 30 days after the last dose of randomized therapy (up to Study Week 29).
SAEs and non-serious AEs were collected for all participants who received at least one dose of study medication.
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 | CT Plus Trastuzumab | Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery. | 14 | 36 | 35 | 36 | ||
| EG001 | CT Plus Lapatinib 1500 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. | 13 | 39 | 38 | 39 | ||
| EG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. | 21 | 46 | 46 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 3.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | CTCAE version 3.0s | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Asthenia | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE version 3.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | CTCAE version 3.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Musculoskeletal and connective tissue disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | CTCAE version 3.0s | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE version 3.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | CTCAE version 3.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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 |
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| D005472 | Fluorouracil |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Unknown |
|
| percentage of participants | 26.3 | 90 | 14.5 | 38.1 | The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response. | No | Superiority or Other |
| percentage of participants | 46.7 | 2-Sided | 90 | 34.4 | 58.9 | The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response. | No | Superiority or Other |
| OG001 | CT Plus Lapatinib 1500 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. |
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|
| OG001 | CT Plus Lapatinib 1500 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. |
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|
| OG001 | CT Plus Lapatinib 1500 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. |
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|
| OG001 |
| CT Plus Lapatinib 1500 mg |
Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach. |
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|
| OG002 | CT Plus Trastuzumab and Lapatinib 1000 mg | Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach. |
|
|