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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00429299 |
Evaluate the activity of Trastuzumab, Lapatinib, and a combination of both agents with chemotherapy in the preoperative (neoadjuvant) treatment of early breast cancer.
Condition | Intervention | Phase |
---|---|---|
Primary Breast Cancer |
Drug: lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Chemotherapy Plus Lapatinib or Trastuzumab or Both in Her2+ Primary Breast Cancer. A Randomized Phase IIb Study With Biomarker Evaluation. |
Estimated Enrollment: | 120 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
HER2 positive tumor (either IHC 3+ or FISH+)
leukocytes ³ 3000/mL
absolute neutrophil count ³ 1,500/mL
platelets ³ 100,000/mL
total bilirubin within normal institutional limits
AST (SGOT)/ALT(SGPT)< 2.5 X institutional upper limit of normal
Creatinine within normal institutional limits
Exclusion criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Germany | |
GSK Investigational Site | Not yet recruiting |
Berlin, Germany, D-13125 | |
Germany, Hessen | |
GSK Investigational Site | Withdrawn |
Offenbach, Hessen, Germany, D-63069 | |
Italy | |
GSK Investigational Site | Active, not recruiting |
Perugia, Italy, 06156 | |
GSK Investigational Site | Recruiting |
Siena, Italy, 53100 | |
GSK Investigational Site | Recruiting |
Varese, Italy, 21100 | |
GSK Investigational Site | Recruiting |
Cremona, Italy, 26100 | |
GSK Investigational Site | Active, not recruiting |
Ancona, Italy, 60020 | |
GSK Investigational Site | Active, not recruiting |
Pavia, Italy, 27100 | |
GSK Investigational Site | Active, not recruiting |
Reggio Emilia, Italy, 42100 | |
Italy, Emilia-Romagna | |
GSK Investigational Site | Recruiting |
Modena, Emilia-Romagna, Italy, 41100 | |
GSK Investigational Site | Recruiting |
Carpi (MO), Emilia-Romagna, Italy, 41012 | |
GSK Investigational Site | Recruiting |
Parma, Emilia-Romagna, Italy, 43100 | |
GSK Investigational Site | Recruiting |
Piacenza, Emilia-Romagna, Italy, 29100 | |
GSK Investigational Site | Recruiting |
Rimini, Emilia-Romagna, Italy, 47900 | |
GSK Investigational Site | Recruiting |
Forlì, Emilia-Romagna, Italy, 47100 | |
Italy, Lombardia | |
GSK Investigational Site | Recruiting |
Treviglio (BG), Lombardia, Italy, 24047 | |
Italy, Piemonte | |
GSK Investigational Site | Recruiting |
Candiolo (TO), Piemonte, Italy, 10060 | |
Italy, Toscana | |
GSK Investigational Site | Recruiting |
Pisa, Toscana, Italy, 56126 | |
Poland | |
GSK Investigational Site | Active, not recruiting |
Warszawa, Poland, 00-909 | |
United Kingdom, Northumberland | |
GSK Investigational Site | Withdrawn |
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF106988, ONCOMO-0105 |
Study First Received: | January 29, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00429299 |
Health Authority: | Italy: Ministry of Health; United States: Food and Drug Administration |
neo-adjuvant
trastuzumab
early breast cancer
lapatinib |
Naphazoline Oxymetazoline Skin Diseases Guaifenesin Phenylephrine |
Trastuzumab Breast Neoplasms Lapatinib Phenylpropanolamine Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |