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

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ClinicalTrials.gov Identifier: NCT00378313
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : November 26, 2008
Sponsor:
Information provided by:
NSABP Foundation Inc

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IV Breast Cancer Breast Cancer Locally Advanced Drug: gemcitabine, epirubicin, paclitaxel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer
Study Start Date : November 2001
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To determine the clinical response rate
  2. to evaluate the toxicity of the GET combination
  3. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378313


Locations
United States, Pennsylvania
NSABP Foundation, Inc.
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Study Chair: John Hamm, MD NSABP Foundation Inc
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
More Information
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Publications of Results:

ClinicalTrials.gov Identifier: NCT00378313     History of Changes
Other Study ID Numbers: NSABP-FB-GE-001
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2008

Keywords provided by NSABP Foundation Inc:
NSABP
gemcitabine
epirubicin
paclitaxel
 Taxol
breast cancer
neoadjuvant chemotherapy
primary chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors