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
|
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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 |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Pennsylvania | |
NSABP Foundation, Inc. | |
Pittsburgh, Pennsylvania, United States, 15212 |
Study Chair: | John Hamm, MD | NSABP Foundation Inc | |
Principal Investigator: | Norman Wolmark, MD | NSABP Foundation Inc |
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 |