Loading
Laboratory Biomarker Analysis / Lapatinib Ditosylate / Trastuzumab · Phase 3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 3 randomized trial registration comparing paclitaxel and trastuzumab with or without lapatinib in stage II–III HER2-positive breast cancer. No results are posted in this registry record; the study design and primary outcome measure (pathologic complete response rate at surgery) are documented but efficacy and safety findings are not reported here.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Male 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 Canc…; age from 18 Years. Intervention: Arm I (THL); Arm III (TL). Compared with: Arm II (TH) — Active Comparator. n = 305. 318 sites: United States, Puerto Rico.
This is a completed Phase 3 randomized trial registration comparing paclitaxel and trastuzumab with or without lapatinib in stage II–III HER2-positive breast cancer. No results are posted in this registry record; the study design and primary outcome measure (pathologic complete response rate at surgery) are documented but efficacy and safety findings are not reported here.
No results reported in this registry entry; outcomes, effect sizes, and safety data are not available here. No data on follow-up duration, disease-free survival, overall survival, or adverse events.
This registry record does not provide clinical evidence because results are not posted. Clinicians should seek the published trial report to assess whether addition of lapatinib to paclitaxel and trastuzumab improves pathologic complete response or survival outcomes in HER2-positive early breast cancer.
This is a clinical trial registry record describing a completed Phase 3 study design with planned enrollment of 305 participants; no results are reported in this registry entry, only the study structure and primary outcome measure.
As stated by the source record.
Quoted from the source exactly as published.
This registry record does not provide clinical evidence because results are not posted. Clinicians should seek the published trial report to assess whether addition of lapatinib to paclitaxel and trastuzumab improves pathologic complete response or survival outcomes in HER2-positive early breast cancer.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00770809). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 305 participants (ACTUAL). Conditions: Male 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. Interventions: OTHER: Laboratory Biomarker Analysis; DRUG: Lapatinib Ditosylate; DRUG: Paclitaxel; BIOLOGICAL: Trastuzumab. Primary outcome measures: pCR Rate , At time of surgery. Brief summary: This 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.