Overview

This trial is active, not recruiting.

Conditions stage i breast cancer, stage ii breast cancer
Treatments cyclophosphamide, paclitaxel, trastuzumab
Phase phase 2
Target HER2
Sponsor University of Nebraska
Collaborator National Cancer Institute (NCI)
Start date March 2010
End date December 2014
Trial size 120 participants
Trial identifier NCT01106898, 371-09, NCI-2010-00608, P30CA036727

Summary

This phase II trial is studying the side effects and how well giving cyclophosphamide and paclitaxel with or without trastuzumab works in treating women with stage I or stage II breast cancer who have undergone surgery. 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 or by stopping them from dividing. Giving monoclonal antibody therapy, such as trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide CPM
Given IV
paclitaxel Anzatax
Given IV
trastuzumab anti-c-erB-2
Given IV

Primary Outcomes

Measure
Primary toxicity (i.e., neutropenia)
time frame: Up to 7 years
Secondary toxicities (i.e., paclitaxel-related neuropathy, grade 3/4 cardiotoxicity and grade 3/4 nausea and vomiting)
time frame: Up to 7 years
Recurrence-free survival
time frame: Defined as the time from the start of treatment to recurrence, second malignancy, or death as a first event , assessed up to 2 years

Eligibility Criteria

Female participants at least 19 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients
      Principal investigator Elizabeth Reed
      Description OBJECTIVES: I. To determine the toxicities and ability to complete the planned treatment of a dose-dense regimen of cyclophosphamide and paclitaxel with or without trastuzumab in patients with newly diagnosed stage I-II breast cancer. II. To estimate recurrence free survival of a dose-dense regimen of cyclophosphamide and paclitaxel with or without trastuzumab in patients with newly diagnosed stage I-II breast cancer. OUTLINE: SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide intravenously (IV) over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 3 years.
      Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
      Information provided to ClinicalTrials.gov by University of Nebraska.
      Location data was received from the National Cancer Institute and was last updated in May 2016.