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Adjuvant Cyclophosphamide and Paclitaxel +/- Trastuzumab in Stage I-II Breast Cancer
NCT01106898Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2010
- Primary completion
- Sep 2015
- Countries
- 1
- Sponsor
- University of Nebraska
- Modality
- Antibody Conjugates, Monoclonal Antibodies, Cytokines & Interferons
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of cyclophosphamide, Paclitaxel Micelles for Injection and trastuzumab in breast cancer, sponsored by University of Nebraska. Primary endpoints: Toxicities and ability to complete the planned treatment and Recurrence-free Survival at 3 years. Started Mar 2010; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment
Cyclophosphamide + Paclitaxel (+ Trastuzumab if HER2+)
03
Who it enrols
Women with newly diagnosed stage I-II breast cancer, no prior chemotherapy, normal cardiac function, and adequate organ function.
04
Endpoints
Primary
Toxicities and ability to complete the planned treatment
Recurrence-free Survival
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