At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed early-stage breast cancer with HER2 positive status by IHC (3+) or FISH
- ✓Resection (mastectomy or lumpectomy) with axillary or sentinel node dissection completed within 84 days
- ✓Negative surgical margins (no invasive cancer or DCIS at resection margins; close margins acceptable)
- ✓ECOG performance status 0–2
- ✕Locally advanced tumors (T4) at diagnosis: fixed to chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes
- ✕Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
- ✕Prior anthracycline or taxane therapy for any malignancy
- ✕Prior EGFR-targeting therapies (e.g., gefitinib, cetuximab, erlotinib, rituximab, trastuzumab, lapatinib, panitumumab, nimotuzumab)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 + Breast Cancer
In Brief
A Phase 2 clinical trial evaluating trastuzumab, cyclophosphamide, and 10 other interventions for Breast Cancer and Cardiac Toxicity. Completed, enrolled 122 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.