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

Sponsor:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by:	National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:	NCT00378313

Purpose

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	Intervention	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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Paclitaxel Epirubicin hydrochloride Epirubicin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:

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:

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

Estimated Enrollment:	76
Study Start Date:	November 2001
Study Completion Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378313

Locations

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

Sponsors and Collaborators

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Investigators

Study Chair:	John Hamm, MD	NSABP Foundation, Inc.
Principal Investigator:	Norman Wolmark, MD	NSABP Foundation, Inc.

More Information

Publications:

Hamm JT, Wilson JW, Rastogi P, Lembersky BC, Tseng GC, Song YK, Kim W, Robidoux A, Raymond JM, Kardinal CG, Shalaby IA, Ansari R, Paik S, Geyer CE, Wolmark N; NSABP Foundation Research Group. Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: a phase II trial of the NSABP Foundation Research Group. Clin Breast Cancer. 2008 Jun;8(3):257-63.

Study ID Numbers:	NSABP-FB-GE-001
Study First Received:	September 7, 2006
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00378313 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

NSABP
gemcitabine
epirubicin
paclitaxel

Taxol
breast cancer
neoadjuvant chemotherapy
primary chemotherapy

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Breast Diseases
Skin Diseases

Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Epirubicin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 05, 2009