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This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery |
|
| Arm 2 | Experimental | Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery |
|
| Arm 3 | Experimental | Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | 4mg/kg IV loading dose followed by 2mg/kg IV weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy | A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal | cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14 | Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value. |
Inclusion Criteria:
Table 1 Baseline Laboratory Values
Hematologic:
ANC (absolute neutrophil count) >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L
Hepatic:
albumin >2.5 g/dL serum bilirubin <1.25 x ULN AST / ALT <3 x ULN if no documented liver metastases AST / ALT <3 x ULN with documented liver metastases
Renal:
serum creatinine <2.0 mg/dL
Non-child-bearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation or hysterectomy, or women who are postmenopausal)
Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility.) This category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate. These subjects must have a negative serum pregnancy test at screening and agree to one of the following:
Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication; or Consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only) where not contraindicated for this subject population or per local practice.; or barrier methods, including diaphragm or condom with a spermicide.
Please note that breast cancer subjects on this trial cannot receive injectable levonorgestrel or injectable progestogen due to the potential for an adverse effect of anti-hormonal therapies on chemotherapy administered for breast cancer [Albain, 2002]. Progestogen may also affect the proliferative rate of endocrine-responsive tumors.
Exclusion Criteria:
History of uncontrolled or symptomatic angina History of arrhythmias requiring medications, or clinically significant Myocardial infarction <6 months from study entry Uncontrolled or symptomatic congestive heart failure Ejection fraction below the institutional normal limit Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fountain Valley | California | 92708 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29156708 | Derived | O'Shea J, Cremona M, Morgan C, Milewska M, Holmes F, Espina V, Liotta L, O'Shaughnessy J, Toomey S, Madden SF, Carr A, Elster N, Hennessy BT, Eustace AJ. A preclinical evaluation of the MEK inhibitor refametinib in HER2-positive breast cancer cell lines including those with acquired resistance to trastuzumab or lapatinib. Oncotarget. 2017 Jul 22;8(49):85120-85135. doi: 10.18632/oncotarget.19461. eCollection 2017 Oct 17. | |
| 24304724 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab | Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel |
| Drug |
80mg/m2 IV weekly for 4 (21 day) cycles |
|
| FEC75 | Drug | 5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles |
|
| Lapatinib | Drug | 1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3 |
|
| Week 26 or EOT or Early withdrawal |
| Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization | Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal. | From first dose date until disease progression, assessed up to a maximum of 5 years |
| Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal | 12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result. | Baseline and EOT (up to Week 26) or Early withdrawal |
| Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline | LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed. | Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course |
| Tumor core biopsy taken at Baseline and Treatment Day 14 |
| Cancer Stem Cells and the Correlation to Response/Non-response to Treatment | Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed. | Tumor core biopsy taken at Baseline and Treatment Day 14 |
| Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment | Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level. | Tumor core biopsy taken at Baseline and Treatment Day 14 |
| Los Angeles |
| California |
| 90057 |
| United States |
| GSK Investigational Site | Denver | Colorado | 80220 | United States |
| GSK Investigational Site | Hudson | Florida | 34667 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33028 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46219 | United States |
| GSK Investigational Site | Henderson | Nevada | 89052 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Austin | Texas | 78731 | United States |
| GSK Investigational Site | Beaumont | Texas | 77702-1449 | United States |
| GSK Investigational Site | Bedford | Texas | 76022 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Dallas | Texas | 75320-2510 | United States |
| GSK Investigational Site | El Paso | Texas | 79915 | United States |
| GSK Investigational Site | Houston | Texas | 77024 | United States |
| GSK Investigational Site | Lewisville | Texas | 75067 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77479 | United States |
| GSK Investigational Site | Tyler | Texas | 75702 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Seattle | Washington | 98117 | United States |
| GSK Investigational Site | Yakima | Washington | 98902 | United States |
| Derived |
| Holmes FA, Espina V, Liotta LA, Nagarwala YM, Danso M, McIntyre KJ, Osborne CR, Anderson T, Krekow L, Blum JL, Pippen J, Florance A, Mahoney J, O'Shaughnessy JA. Pathologic complete response after preoperative anti-HER2 therapy correlates with alterations in PTEN, FOXO, phosphorylated Stat5, and autophagy protein signaling. BMC Res Notes. 2013 Dec 5;6:507. doi: 10.1186/1756-0500-6-507. |
| FG001 | Lapatinib | Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. |
| FG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab | Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. |
| BG001 | Lapatinib | Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. |
| BG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
| 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 | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy | A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel. | Intent-to-Treat-Evaluable (ITT-E) Population: ITT participants with evaluable tumor responses who had been >=75% compliant to 5-fluorouracil (5-FU) 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 (FEC75) and paclitaxel 80 mg/m^2 and had undergone surgery. | Posted | Number | percentage of participants | Week 26 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal | cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. | ITT Population: all randomized participants regardless of whether they had received any treatment. | Posted | Number | percentage of participants | Week 26 or EOT or Early withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization | Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal. | ITT Population | Posted | Number | 95% Confidence Interval | Percentage | From first dose date until disease progression, assessed up to a maximum of 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal | 12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result. | Safety Population: all randomized participants (par) who received at least one dose of investigational product, based on actual treatment received if this differed from that to which par was randomized. Not all par were analyzed: some par were randomized to an arm they did not want or par were randomized in error (eligibility criteria weren't met). | Posted | Number | participants | Baseline and EOT (up to Week 26) or Early withdrawal |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline | LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed. | Safety Population. Not all participants in the Safety Population were analyzed: some participants were randomized to an arm they did not want or participants were randomized in error (eligibility criteria weren't met). | Posted | Number | participants | Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14 | Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value. | ITT-E Population. Only those participants with matched pairs of biopsy samples for analysis at Baseline and on Day 14 were analyzed. | Posted | Mean | Standard Deviation | : normalized relative expression level | Tumor core biopsy taken at Baseline and Treatment Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cancer Stem Cells and the Correlation to Response/Non-response to Treatment | Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed. | Posted | Tumor core biopsy taken at Baseline and Treatment Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment | Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level. | Posted | Tumor core biopsy taken at Baseline and Treatment Day 14 |
|
Not provided
In the Safety Population, serious and non-serious adverse events were collected from all randomized participants who received at least one dose of investigational product and was based on the actual treatment received if this differed from that to which the participant was randomized.
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 | Trastuzumab | Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab. | 7 | 32 | 31 | 32 | ||
| EG001 | Lapatinib | Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. | 7 | 34 | 34 | 34 | ||
| EG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. | 8 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile nuetropenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cellilitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysponea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pruritus genralised | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Blood lactate dehygrogenase increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Alanine aminotranferase decreased | Investigations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Dysponoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA, Version 14.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA, Version 14.0 | 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 |
|---|---|
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| American Indian or Alaska native |
|
| Asian - Central/South Asian heritage |
|
| Asian - East Asian heritage |
|
| Asian - South East Asian heritage |
|
| White - Arabic/North African heritage |
|
| White - White/Caucasian/European heritage |
|
| Mixed race |
|
| Percent difference |
| 20 |
| 2-Sided |
| 95 |
| -8.0 |
| 49.4 |
Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated. |
| No |
| Superiority or Other |
| OG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
|
|
|
| OG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
|
|
Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
| OG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
|
|
| OG001 |
| Lapatinib |
Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. |
| OG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
|
|
| OG001 | Lapatinib | Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib. |
|
|
| OG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
|
| OG002 | Trastuzumab+Lapatinib | Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib. |
|