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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Breast Cancer Research Foundation
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Epirubicin; Fluorouracil; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

1. 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.

2. Patients should have adequate organ function to tolerate chemotherapy.

3. Patient must be willing to undergo a one-time pretreatment research FNA biopsy

Exclusion Criteria:

1. 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.

2. Patients with stage IV, metastatic breast cancers are not eligible.

3. Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, for example Patients who are pregnant or lactating are not eligible.