Phase II Open-Label Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer
Sponsor study identifier
interventional
34
1 country
1
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the efficacy and safety of weekly paclitaxel and carboplatin, in combination with lapatinib, in the neoadjuvant treatment of non-metastatic erbB2-positive breast cancer. Secondary objectives include:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 3, 2011
Actual (reported)March 7, 2011
Actual (reported)April 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rate of pathologic complete response
12 weeks
Treatment related toxicities
12 weeks
Breast conservation rates
16 weeks
Clinical response rates
1 year
Relapse free survival (RFS)
2 years
Identification of tumor biomarkers that predict pathologic complete response
16 weeks
Neoadjuvant paclitaxel/carboplatin/lapatinib x 12 weeks
Drug doses for the neoadjuvant regimen: * Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle * Carboplatin AUC of 2, day 1, 8 of a 21-day cycle * Lapatinib 750mg daily continuously
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
paclitaxel/carboplatin/lapatinib
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNational University Hospital
Singapore, 119228, Singapore
Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.
Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006 Dec 28;355(26):2733-43. doi: 10.1056/NEJMoa064320.
Soo Chin Lee
National University Hospital, Singapore
First Submitted
March 3, 2011
First Posted
March 7, 2011
Study Start
April 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 15, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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