A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer
18 Years
N/A
Female
Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer, Breast Cancer, Locally Advanced
Trial Information
A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Principal Investigator
John Hamm, MD
Investigator Role:
Study Chair
Investigator Affiliation:
NSABP Foundation, Inc.
Authority:
United States: Institutional Review Board
Study ID:
NSABP-FB-GE-001
NCT ID:
NCT00378313
Start Date:
November 2001
Completion Date:
November 2005
Related Keywords:
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IV Breast Cancer
- Breast Cancer
- Locally Advanced
- NSABP
- gemcitabine
- epirubicin
- paclitaxel
- Taxol
- breast cancer
- neoadjuvant chemotherapy
- primary chemotherapy
- Breast Neoplasms
Name | Location |
|---|---|
| NSABP Foundation, Inc. | Pittsburgh, Pennsylvania 15212 |
