MDACC Study Summary 2003-0321 (Archived)

Study Summary
No. 2003-0321:.......Breast......Lajos Pusztai......Breast Medical Oncology

Study Summary Title



Study Summary Number:	2003-0321

Study Title:	Randomized clinical trial to evaluate the predictive accuracy of a gene expression profile-based test to select patients for preoperative taxane/anthracycline chemotherapy for stage I-III breast cancer

Physician

New Patient Referral



Name:	Lajos Pusztai	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Breast Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2817 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Every 1-3 weeks.

Treatment Agents:	5-Fluorouracil Cyclophosphamide Doxorubicin Paclitaxel	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	None

Description/
Intervention:

The goal of this clinical research study is to learn how well a new test can
predict which patients' cancer cells might disappear completely from the breast
and lymph nodes after 18-24 weeks of standard preoperative chemotherapy. It is
hoped that this research will lead to the development of clinical tests that
can help physicians to select the best chemotherapy for an individual. Another
goal of this research is to create a large database of molecular abnormalities
in cancer that will help researchers study the cause of breast cancer and find
new ways of treatment.

Study Objectives / Outcomes

A main objective of this clinical trial is 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 chemotherapy for stage I-III breast cancer. The second main objective is to evaluate if our genomic predictive test is specific to the paclitaxel /FAC regimen or it also predicts increased sensitivity to FAC only chemotherapy. The secondary objectives are (i) to discover a molecular profile that is associated with pCR after FAC chemotherapy alone, (ii) to establish a prospectively collected gene expression profile data bank of breast cancer for future studies, and (iii) to compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.

Study Status Information



Study Activation / Registration Date:	09/02/2003

IRB Review and Approval Date:	06/04/2003

Study Type:	Diagnostic

Recruitment Status:	Terminated

Projected Accrual:	273

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 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.

Links

Registration Number: NCT00336791
Study Information on Clinical Trials Registry (clinicaltrials.gov)