18 and older, any sex, with Male Breast Carcinoma or Stage IIA Breast Cancer AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
pCR RatePrimary· At time of surgery
Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H\&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.
Group
Value
95% CI
Arm I (THL)
56
47 – 65
Arm II (TH)
46
35 – 55
Arm III (TL)
32
22 – 45
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm I (THL)
Serious: 15/115 (13%)
Deaths: —
Arm II (TH)
Serious: 12/115 (10%)
Deaths: —
Arm III (TL)
Serious: 6/65 (9%)
Deaths: —
Serious adverse events (41 terms)
Reaction
System
Arm I (THL)
Arm II (TH)
Arm III (TL)
Diarrhea
Gastrointestinal disorders
—
—
—
Fatigue
General disorders
—
—
—
Hemoglobin decreased
Blood and lymphatic system disorders
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
Peripheral sensory neuropathy
Nervous system disorders
—
—
—
Neutrophil count decreased
Investigations
—
—
—
Rash desquamating
Skin and subcutaneous tissue disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
Serum potassium decreased
Metabolism and nutrition disorders
—
—
—
Myalgia
Musculoskeletal and connective tissue disorders
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Cardiopulmonary arrest
Cardiac disorders
—
—
—
Pericarditis
Cardiac disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
Pancreatitis
Gastrointestinal disorders
—
—
—
Edema limbs
General disorders
—
—
—
Hypersensitivity
Immune system disorders
—
—
—
Gallbladder infection
Infections and infestations
—
—
—
Infection
Infections and infestations
—
—
—
Pneumonia
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Other adverse events (131 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00770809.