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

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	M.D. Anderson Cancer Center Breast Cancer Research Foundation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00336791

Purpose

Primary Objectives:

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.
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:

To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.

Condition	Intervention	Phase
Breast Cancer	Drug: 5-Fluorouracil Drug: Cyclophosphamide Drug: Doxorubicin Drug: Paclitaxel	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Paclitaxel Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official 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

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	273
Study Start Date:	September 2003

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Patients should have adequate organ function to tolerate chemotherapy.
Patient must be willing to undergo a one-time pretreatment research FNA biopsy

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336791

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Breast Cancer Research Foundation

Investigators


Principal Investigator:	Lajos Pusztai, MD	M.D. Anderson Cancer Center

More Information

Study ID Numbers:	2003-0321
First Received:	June 12, 2006
Last Updated:	July 12, 2007
ClinicalTrials.gov Identifier:	NCT00336791
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer

Gene Expression

Fluorouracil

Cyclophosphamide

Doxorubicin

Paclitaxel

Study placed in the following topic categories:

Skin Diseases

Paclitaxel

Fluorouracil

Breast Neoplasms

Cyclophosphamide

Taxane

Doxorubicin

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Mitosis Modulators

Physiological Effects of Drugs

Antimitotic Agents

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Tubulin Modulators

Myeloablative Agonists

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Antineoplastic Agents, Phytogenic

Alkylating Agents

ClinicalTrials.gov processed this record on September 23, 2008