A Study of Gemcitabine, Epirubicin, and Paclitaxel Combination Chemotherapy Given Before Surgery to Patients With Locally Advanced Breast Cancer

November 24, 2008 updated by: NSABP Foundation Inc

A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer

The primary purpose of this study is to determine whether locally advanced breast cancer responds (by shrinking, by not progressing or by being destroyed) to combined chemotherapy (gemcitabine, epirubicin and paclitaxel) given before surgery to patients with locally advanced breast cancer. This study will also evaluate the toxicity of the chemotherapy combination to patients and will determine survival and progression-free survival 2 years after treatment. Also, the study will look at whether there are molecular and genetic changes in the tumor tissue that match the tumor's response to the chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary chemotherapy has had an established role in locally advanced breast cancer. Studies have shown that the combination of chemotherapeutic agents is superior to single therapeutic agent in overall response rate and progression free survival. The inclusion of the most active drugs in combination regimens can improve the percentage of patients achieving a pathological complete response (pCR). The chemotherapy agents gemcitabine, epirubicin, and paclitaxel have been used individually to treat breast cancer. While use of the combination of these three drugs has been studied in the metastatic setting, the combination has not been evaluated in locally advanced disease. In this study the combination of the three agents gemcitabine, epirubicin, and paclitaxel [Taxol] will be administered to patients with locally advanced breast cancer prior to surgery; pathologic response will be determined at the time of surgery. The main objective of this study is to determine the pathological response rate for these patients. Also because prior studies have suggested that only a specific subset of tumors responds to a specific chemotherapeutic agent and that this subset is determined by the gene expression profile of each tumor, preoperative therapy protocols such as this provide an ideal setting to identify gene expression pattern and gene copy number changes that may predict response to a specific therapy using high-throughput assay methods and RNAlater. Therefore, this study will also look at the feasibility of tissue collection and analysis in identifying predictive markers of complete pathological response.

Study Type

Interventional

Enrollment

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • NSABP Foundation, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Females only
  • Consent for the collection of biopsy tissue in RNAlater solution
  • Biopsy specimens that were obtained by core biopsy or incisional biopsy and placed in RNAlater solution

  • Breast cancer that is:

    • unilateral
    • diagnosed histologically as invasive breast cancer without evidence of metastatic disease (except for stage IV with positive supraclavicular nodes only)
    • stage IIB, IIIA (T0-3N2), IIIB (T4N0-3 or T0-3N3), or IV (by involvement of positive supraclavicular nodes only). (Patients with clinical evidence of inflammatory breast cancer or superficial lesions must have a measurable mass in the breast or lymph nodes.)
    • measurable by physical exam, mammography, sonogram, CT scan, MRI, or x-ray
  • Evidence of adequate organ function (liver, bone marrow, kidney)
  • Ability to perform an adequate level of physical activity (Zubrod scale 0, 1, or 2)
  • Life expectancy of at least 10 years
  • Childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an effective non-hormonal, barrier contraceptive method
  • Disease-free from prior nonbreast malignancies for at least 5 years before entry
  • Adequate cardiac function( measured by baseline LVEF on MUGA or echocardiogram greater than or equal to the institution's lower limit of normal)

Exclusion criteria:

  • Male
  • Hormonal birth control
  • The use of hormonal agents or raloxifene
  • Active infection
  • Pregnancy or breastfeeding
  • Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
  • Previous therapy for breast cancer
  • Nonmalignant systemic disease that would keep the patient from being given the treatment or would prevent long-term follow-up
  • Active cardiac disease that would preclude the use of epirubicin and/or Taxol
  • Significant abnormal peripheral nerve disease (greater than or equal to Grade 2)
  • Any prior anthracycline or taxane-containing chemotherapy
  • Use of any investigational agent within one month before enrollment
  • Excisional biopsy of the breast

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the pathological response rate in tumors of patients with locally advanced breast cancer who receive 4 to 6 cycles of GET chemotherapy

Secondary Outcome Measures

Outcome Measure
To determine the clinical response rate
to evaluate the toxicity of the GET combination
to determine feasibility of tissue collection and analysis of potential molecular and genetic correlates of response; to determine the 2-year survival and 2-year progression-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Investigators

  • Study Chair: John Hamm, MD, NSABP Foundation Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 26, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSABP-FB-GE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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