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NCT02654119 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery
A Phase 2 study of HER2-Positive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT02654119: Completed Phase 2 study of HER2-Positive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by University of Nebraska.
NCT02654119 is a Phase 2 study of HER2-Positive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7 that has completed, run by University of Nebraska. The registered enrollment target is 20 participants, below the 166-participant average among 12 other HER2-Positive Breast Carcinoma trials with a reported enrollment target (88% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02654119, a Phase 2 study of HER2-Positive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Number of participants who experienced treatment-emergent neutropenia graded according to National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) v4.03.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- BIOLOGICAL Trastuzumab
Study Locations (3)
Nebraska
- Faith Regional Health Services Carson Cancer Center - Norfolk
- Nebraska Medicine-Village Pointe - Omaha
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-12-11 |
| Est. Completion | 2025-12-08 |
| Phase | Phase 2 |
What the finished NCT02654119 record still lists
NCT02654119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 166-participant average among 12 other HER2-Positive Breast Carcinoma trials with a reported enrollment target (88% lower).
The record links to 7 conditions, with HER2-Positive Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02654119 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT02654119 about?
NCT02654119 is a clinical study titled "Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery". 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 un...
What is the current status of trial NCT02654119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-12-11. Estimated completion is 2025-12-08.
What conditions does trial NCT02654119 study?
This clinical trial studies the following conditions: HER2-Positive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IB Breast Cancer AJCC v7, Stage IIB Breast Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT02654119?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02654119?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02654119 being conducted?
This trial has 3 study locations across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-Positive Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02654119's enrollment target sits among peer trials
20 10th of 12 higher than 3 of 12 other HER2-Positive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Positive Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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