Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
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 paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy
for stage I-III breast cancer.
2. To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or
it also predicts increased sensitivity to FAC only chemotherapy.
Secondary Objectives:
1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
2. To establish a prospectively collected gene expression profile data bank of breast
cancer for future studies
3. To compare the pCR rates between patients who receive 6 courses FAC and those who
receive sequential paclitaxel /FAC chemotherapies.