Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer
NCT ID: NCT00429299
Last Updated: 2016-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2006-08-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Chemotherapy plus trastuzumab
trastuzumab
First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
paclitaxel
80mg/sqm 1 hour infusion for 12 weeks
fluorouracil
600mg/sqm iv day 1 q21 days for four coursess
epidoxorubicin
75mg/sqm iv day 1 q21 days for four courses
cyclophosphamide
600mg/sqm day 1 q21 days for four courses
Arm B
Chemotherapy plus lapatinib
lapatinib
Arm B 1250mg/d PO Arm C 750mg/d PO
paclitaxel
80mg/sqm 1 hour infusion for 12 weeks
fluorouracil
600mg/sqm iv day 1 q21 days for four coursess
epidoxorubicin
75mg/sqm iv day 1 q21 days for four courses
cyclophosphamide
600mg/sqm day 1 q21 days for four courses
Arm C
Chemotherapy plus trastuzumab plus lapatinib
lapatinib
Arm B 1250mg/d PO Arm C 750mg/d PO
trastuzumab
First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
paclitaxel
80mg/sqm 1 hour infusion for 12 weeks
fluorouracil
600mg/sqm iv day 1 q21 days for four coursess
epidoxorubicin
75mg/sqm iv day 1 q21 days for four courses
cyclophosphamide
600mg/sqm day 1 q21 days for four courses
Interventions
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lapatinib
Arm B 1250mg/d PO Arm C 750mg/d PO
trastuzumab
First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins
paclitaxel
80mg/sqm 1 hour infusion for 12 weeks
fluorouracil
600mg/sqm iv day 1 q21 days for four coursess
epidoxorubicin
75mg/sqm iv day 1 q21 days for four courses
cyclophosphamide
600mg/sqm day 1 q21 days for four courses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
HER2 positive tumor (either IHC 3+ or FISH+)
* Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
* Age \>18, \< 65 years
* ECOG PS 0-1
* Normal organ and marrow function as defined below:
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
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan
* Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided
* The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately, the patient should be apprised of the potential hazard to the fetus and potential risk for loss of the pregnancy
* Ability to understand and the willingness to sign a written informed consent document
* Ability to swallow and retain oral medication
Exclusion Criteria
* Stage IV breast cancer
* Contraindication to the treatment with anthracycline, paclitaxel and/or trastuzumab
* Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies
* Treatment with any other investigational agents, or with all herbal (alternative) medicines
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnancy or breastfeeding; (breast feeding should be discontinued to be enrolled in the study)
* Women of childbearing potential that refusal to adopt adequate contraceptive measures
* HIV-positive patients receiving combination anti-retroviral therapy
* GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
* Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
18 Years
65 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Carpi (MO), Emilia-Romagna, Italy
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Brindisi, Apulia, Italy
GSK Investigational Site
Forlì, Emilia-Romagna, Italy
GSK Investigational Site
Modena, Emilia-Romagna, Italy
GSK Investigational Site
Parma, Emilia-Romagna, Italy
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy
GSK Investigational Site
Rimini, Emilia-Romagna, Italy
GSK Investigational Site
Treviglio (BG), Lombardy, Italy
GSK Investigational Site
Candiolo (TO), Piedmont, Italy
GSK Investigational Site
Pisa, Tuscany, Italy
GSK Investigational Site
Cremona, , Italy
GSK Investigational Site
Pavia, , Italy
GSK Investigational Site
Perugia, , Italy
GSK Investigational Site
Reggio Emilia, , Italy
GSK Investigational Site
Varese, , Italy
GSK Investigational Site
Warsaw, , Poland
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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EGF106988
Identifier Type: -
Identifier Source: org_study_id
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