Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Treating Women With Stage I or Stage II Breast Cancer Who Have Undergone Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Nebraska
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01106898
First received: April 13, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Stage I Breast Cancer
Stage II Breast Cancer
Drug: cyclophosphamide
Drug: paclitaxel
Biological: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Primary toxicity (i.e., neutropenia) [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]
    Evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Descriptive statistics will be computed for all variables to examine data quality. Variable distributions will be examined using stem-and-leaf plots, means, medians, standard deviations, ranges and frequencies, and 90% confidence intervals. Descriptive statistics, including 90% confidence intervals, will also be examined for subjects treated with and without trastuzumab for patients with stage I and II disease.

  • Secondary toxicities (i.e., paclitaxel-related neuropathy, grade 3/4 cardiotoxicity and grade 3/4 nausea and vomiting) [ Time Frame: Up to 7 years ] [ Designated as safety issue: Yes ]
    Evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Descriptive statistics will be computed for all variables to examine data quality. Variable distributions will be examined using stem-and-leaf plots, means, medians, standard deviations, ranges and frequencies, and 90% confidence intervals. Descriptive statistics, including 90% confidence intervals, will also be examined for subjects treated with and without trastuzumab for patients with stage I and II disease.

  • 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 ] [ Designated as safety issue: No ]
    Recurrence-free survival curves will be plotted following the method of Kaplan and Meier. Recurrence-free survival curves will also be provided for subjects treated with and without trastuzumab for patients with stage I and II disease.


Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy with or without maintenance therapy)

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.

Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically confirmed newly diagnosed Stage I-II breast cancer Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Absolute neutrophil count greater than or equal to 1,500/mcl Platelet count equal to or greater than 150,000/mcl Hemoglobin > 11gm/dl Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN) Total bilirubin equal to or less than 1.5 times the ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN Creatinine less than 1.5 times the ULN Able to give informed consent All included patients must have normal cardiac function as defined by an ejection fraction of > 50% by echocardiogram Able to return for treatment and follow-up on the specified days

Exclusion Criteria:

Prior malignancy; except for adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas Patients with pre existing Grade II peripheral neuropathy Patients with prior chemotherapy Stage IV or metastatic breast cancer Pregnant or nursing women Inability to cooperate with treatment protocol No active serious infections or other conditions precluding chemotherapy Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol (e.g. unstable angina, myocardial infarction within 6 months, severe infection, etc.) Known hypersensitivity to any component of required drugs in the study Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C or active hepatitis Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities (Prior to study entry, any electrocardiograph [ECG] abnormality at screening has to be documented by the investigator as not medically relevant)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106898

Contacts
Contact: Mary Mailliard, RN BSN OCN 402-559-5582 mjmailli@unmc.edu
Contact: Marsha Ketcham, RN OCN 402-559-5286 mketcham@unmc.edu

Locations
United States, Nebraska
Saint Francis Medical Center Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Mehmet S. Copur    308-398-6518    mcopur@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Elizabeth C. Reed    402-559-5520    ereed@unmc.edu   
Principal Investigator: Elizabeth C. Reed         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Elizabeth Reed University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01106898     History of Changes
Other Study ID Numbers: 371-09, NCI-2010-00608, P30CA036727
Study First Received: April 13, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Paclitaxel
Trastuzumab
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014