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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2014-01-31
NCT00770809Uploaded 02-02-2024
Access via NCI by Request
PDS UID: nci-data-531
Randomized Phase III Trial of Paclitaxel +Trastuzumab + Lapatinib Versus Paclitaxel + Trastuzumab as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer
Provider Information
Provider Data DescriptionDataset NCT00770809-D1-Dataset.csv (consort) is one of 7 datasets associated with PubMed ID 26527775. This dataset contains information for the treatment consort diagram and evaluability of patients for the efficacy analysis.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.
ConditionsMale Breast Carcinoma
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIA Breast Cancer AJCC v7
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Intervention TypeOther: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
Drug: Paclitaxel
Biological: Trastuzumab
Drug(s)Drug: Lapatinib Ditosylate
Drug: Paclitaxel
Total Enrolled305
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (THL) - Experimental
Arm II (TH) - Active Comparator
Arm III (TL) - Experimental
Secondary IDNCI-2009-01073
PubMed (PMID)33095682
26527775
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00770809-D1
Data DictionaryNCT00770809-D1-Data-Dictionary_0.pdf
DATANCT00770809-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D2
Data DictionaryNCT00770809-D2-Data-Dictionary_0.pdf
DATANCT00770809-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D3
Data DictionaryNCT00770809-D3-Data-Dictionary_0.pdf
DATANCT00770809-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D4
Data DictionaryNCT00770809-D4-Data-Dictionary_0.pdf
DATANCT00770809-D4-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D5
Data DictionaryNCT00770809-D5-Data-Dictionary_0.pdf
DATANCT00770809-D5-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D6
Data DictionaryNCT00770809-D6-Data-Dictionary_0.pdf
DATANCT00770809-D6-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D7
Data DictionaryNCT00770809-D7-Data-Dictionary_0.pdf
DATANCT00770809-D7-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00770809-D8
Data DictionaryNCT00770809-D8-Data-Dictionary.pdf
DATANCT00770809-D8-Dataset.csv
OTHERREADME.pdf
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