At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed breast cancer, clinical stage I-III
- ✓HER2/neu 3+ by IHC or positive by FISH
- ✓Measurable disease ≥20 mm by conventional imaging or ≥10 mm by spiral CT
- ✓ECOG performance status 0-1 OR Karnofsky 80-100%
- ✕Known brain metastases
- ✕Prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer
- ✕Prior treatment with EGFR-targeting therapies
- ✕Prior surgery for breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Neoadjuvant Trial in Breast Cancer With Combination of ABI-007 (Abraxane) and GW572016 (Lapatinib)
In Brief
A Early Phase 1 clinical trial evaluating lapatinib ditosylate and paclitaxel albumin-stabilized nanoparticle formulation for Breast Cancer. Completed, enrolled 30 participants across 5 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving Abraxane together with lapatinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving Abraxane together with lapatinib works in treating patients with stage I, stage II, or stage III breast cancer.
Study Details
Timeline
Interventions
Oral lapatinib is taken once daily on days 1-21 of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
30 patients receive Abraxane IV over 30 minutes on day 1 each of each treatment cycle. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.