Gene Expression Profiling and Genetic Analysis of Tissues From Patients With Breast Cancer - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group North Central Cancer Treatment Group Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899509

Purpose

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs.

PURPOSE: This laboratory study is analyzing the DNA in tumor tissue from women with node-positive breast cancer to see if genetic factors are related to the patient's response to chemotherapy.

Condition	Intervention
Breast Cancer	Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Genetic: molecular genetic technique Other: immunohistochemistry staining method

Study Type:	Observational
Official Title:	Correlative Studies of ERBB-2/HER-2/NEU and p53 in CALGB Protocol 9344/INT Protocol 0148: "Doxorubicin Dose Escalation, With or Without Taxol®, as Part of the CA Adjuvant Chemotherapy Regimen For Node Positivie Breast Cancer: A Phase III Intergroup Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation of erbB-2 (HER-2/neu) amplification and/or overexpression with more or less benefit from increasing dose of doxorubicin or addition of paclitaxel in women with node-positive breast cancer, in terms of disease-free and overall survival [ Designated as safety issue: No ]
Correlation of abnormalities in p53 (mutations, deletions, protein stabilization) with additional or less benefit (in terms of disease-free and overall survival) [ Designated as safety issue: No ]
Comparison of methods of assaying for erbB-2 (HER-2/neu) and p53 to determine whether one method is more predictive of clinical outcome in these patients than the other [ Designated as safety issue: No ]

Study Start Date:

October 2000

Detailed Description:

OBJECTIVES:

Correlate erbB-2 (HER-2/neu) amplification and/or overexpression with additional or less benefit derived from increasing doses of doxorubicin or addition of paclitaxel in women with node-positive breast cancer, in terms of disease-free and overall survival.
Correlate abnormalities in p53 (mutations, deletions, protein stabilization) with additional or less benefit (in terms of disease-free and overall survival) in patients treated with these regimens.
Compare methods of assaying for erbB-2 (HER-2/neu) and p53 to determine whether one method is more predictive of clinical outcome in these patients than the other.

OUTLINE: Formalin-fixed, paraffin-embedded tissue blocks are analyzed for amplification and/or overexpression of erbB-2 (HER-2/neu) and for mutations or deletions of p53 by fluorescent in situ hybridization (FISH) and immunohistochemistry.

PROJECTED ACCRUAL: Samples will be collected from a total of 600 patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast with 1 or more positive lymph nodes (T1-3, N1, M0)
Prior enrollment on CLB-9344
At least 1 block of primary tumor available for sectioning and submission
Hormone-receptor status
- Any estrogen receptor or progesterone receptor status

PATIENT CHARACTERISTICS:

Female
Menopausal status: pre- or post-menopausal

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899509

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

North Central Cancer Treatment Group

Southwest Oncology Group

Investigators

Study Chair:	Matthew J. Ellis, MD, PhD, FRCP	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Study Chair:	Ann D. Thor, MD	University of Oklahoma College of Medicine
Study Chair:	Edith A. Perez, MD	Mayo Clinic
Study Chair:	D. C. Allred, MD	Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000285697, CALGB-159905, ECOG-C159905, NCCTG-C159905, SWOG-C159905
Study First Received:	May 9, 2009
Last Updated:	May 16, 2009
ClinicalTrials.gov Identifier:	NCT00899509 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage IIIA breast cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Adjuvants, Immunologic

Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009