Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00336791

Run by

M.D. Anderson Cancer Center

People needed

273

Starts

2003-09-01

Expected to finish

2010-09-01

Last updated by the study team

2012-02-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States
• Centro Medico Nacional de Occidente — Guadalajara, Mexico
• Instituto Nacional de Enfermedades Neoplasicas — Lima, Peru
• Grupo Español de Investigacion en Cancer de Mama — Madrid, Spain

Full record on ClinicalTrials.gov

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