Primary Treatment: Trastuzumab · No Placebo Group · Phase 3
Arm I (THL)Experimental Group · 4 Interventions: Lapatinib Ditosylate, Trastuzumab, Laboratory Biomarker Analysis, Paclitaxel · Intervention Types: Drug, Biological, Other, Drug
Arm III (TL)Experimental Group · 2 Interventions: Lapatinib Ditosylate, Paclitaxel · Intervention Types: Drug, Drug
Arm II (TH)ActiveComparator Group · 3 Interventions: Trastuzumab, Laboratory Biomarker Analysis, Paclitaxel · Intervention Types: Biological, Other, Drug
Drug Approval Stage
How many patients have taken this drug
Screening: ~3 weeks
Reporting: time from surgery to any recurrence (up to 10 years)
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,583 Total Patients Enrolled
923 Trials studying Breast Cancer
1,535,609 Patients Enrolled for Breast Cancer
Lisa A CareyPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:
Target lesions in the breast must be >= 1 cm on physical examination or by radiographic measurement; palpable axillary adenopathy will be documented but not serve as measurable disease for the primary endpoint; patients with axillary disease only are not eligible to participate.
to monitor response to therapy
The patient agrees to provide biopsies of the treatment area before and after treatment to monitor the response to the therapy.
The patient has not received any chemotherapy, hormone therapy, biologic therapy, or radiation therapy with therapeutic intent for this cancer.
Pathologic confirmation of breast cancer is required; patients with inflammatory breast cancer are not eligible.
This text is about a woman who has breast cancer that is at stage II or III
with a high suspicion for metastatic disease
The tumor must be positive for the HER2 protein, as determined by an immunohistochemical assay or a gene amplification assay, with a HER2 to tumor cell ratio of greater than or equal to 2
The cardiac ejection fraction must be >= 50% by either an echocardiogram or a multiple gated acquisition (MUGA) scan.
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.