Status:
COMPLETED
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Breast Cancer
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Primary Objectives: 1. To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response (pCR) to preoperative p...
Detailed Description
The new test being studied measures the presence or absence of each of 12,000-15,000 human genes in the cancer using "DNA chip" technology. All of the therapeutic treatment that you will receive is pa...
Eligibility Criteria
Inclusion
- Histologically confirmed stage I-III invasive carcinoma of the breast for whom adjuvant chemotherapy is indicated. Patients must have intact or measurable residual cancer (by mammogram, ultra sonogram or physical exam) in the breast. Women of childbearing potential must have a negative pregnancy test (serum or urine beta Human chorionic gonadotropin (HCG)) prior to initiation of chemotherapy.
- Patients should have adequate organ function to tolerate chemotherapy.
- Patient must be willing to undergo a one-time pretreatment research FNA biopsy
Exclusion
- Patients who have completed lumpectomy, segmental mastectomy or modified radical mastectomy and, therefore no longer have any measurable cancer left in their breast are not eligible.
- Patients with stage IV, metastatic breast cancers are not eligible.
- Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, for example Patients who are pregnant or lactating are not eligible.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT00336791
Start Date
September 1 2003
End Date
September 1 2010
Last Update
February 14 2012
Active Locations (4)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
Centro Medico Nacional de Occidente
Guadalajara, Mexico
3
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru
4
Grupo Español de Investigacion en Cancer de Mama
Madrid, Spain