BENITIONSClinical Trial Intelligence

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery

Phase 2 Completed NCT02654119

ConditionHER2 Positive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
PhasePhase 2
SponsorUniversity of Nebraska
StatusCompleted
Enrollment20 participants
InterventionsCyclophosphamide, Laboratory Biomarker Analysis, Paclitaxel, Trastuzumab
Start dateDec 11, 2015
Completion dateDec 8, 2025
Results postedMar 23, 2026

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.

Number of Participants With Neutropenia

From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab). · Participants

Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)2 Participants

Number of Participants With Paclitaxel-related Neuropathy

From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab). · Participants

Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)1 Participants
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)14 Participants

Number of Participants With Cardiotoxicity Grade 3/4 Cardiotoxicity, Graded According to the NCI CTCAE v4.03

From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab). · Participants

Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)2 Participants

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