At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer
- ✓ECOG performance status 0 or 1
- ✓Normal cardiac function with ejection fraction >50% by echocardiogram
- ✓Absolute neutrophil count ≥1,500/mcl within 30 days prior to enrollment
- ✕Prior malignancy (except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas)
- ✕Pre-existing grade II peripheral neuropathy
- ✕History of previous chemotherapy
- ✕Stage IV or metastatic breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With Trastuzumab in Stage I-II HER2/Neu Positive Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Laboratory Biomarker Analysis, and 2 other interventions for HER2 Positive Breast Carcinoma and 6 related conditions. Completed, enrolled 20 participants across 3 sites.
Detailed Summary
This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and 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, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.
Study Details
Timeline
Interventions
Given IV
Correlative studies
Given IV
Given IV