Phase 2
N=20
Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer
HER2-Positive Early Stage Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01827163 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation — 16; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Trastuzumab (Drug); Lapatinib (Drug); Pegfilgrastim (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation |
16; 4 | — |
| SECONDARY Participants Toxicity Evaluated While on Study Treatment |
20 | — |
Summary
The purpose of this study is to study a new treatment for HER2-positive breast cancer.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of ≥ 2.0
- Tumor size of ≤ 3 cm and node-negative disease. Nodes with single cells or tumor clusters 500 ms) or require drugs that may prolong the QT.
- Subjects who have current active hepatic (including hepatitis B or C) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones).
- Patients with active, unresolved infections.
- Patients with a sensitivity to E. coli derived proteins.
Data sourced from ClinicalTrials.gov (NCT01827163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.