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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 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.

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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.

Conditions Studied

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 Stage IA Breast Cancer AJCC v7 Stage I Breast Cancer AJCC v7

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

FieldValue
Enrollment Target 20 participants
Start Date 2015-12-11
Est. Completion 2025-12-08
Phase Phase 2

Sponsor

University of Nebraska

407 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02654119

The ClinicalTrials.gov registry entry for NCT02654119 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 166-participant average among 12 other HER2-Positive Breast Carcinoma trials with a reported enrollment target (88% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 1 distinct geographic area - top geographies include 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.

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