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A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients


Phase 2
19 Years
N/A
Open (Enrolling)
Female
Stage I Breast Cancer, Stage II Breast Cancer

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Trial Information

A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Primary toxicity (i.e., neutropenia)

Outcome Description:

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.

Outcome Time Frame:

Up to 7 years

Safety Issue:

Yes

Principal Investigator

Elizabeth Reed

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

371-09

NCT ID:

NCT01106898

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Breast Neoplasms

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Saint Francis Medical CenterGrand Island, Nebraska  68802