Gene Expression Profiling and Genetic Analysis of Tissues From Patients With Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00899509
First received: May 9, 2009
Last updated: July 15, 2013
Last verified: October 2012
  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 Positive Breast Cancer: A Phase III Intergroup Study

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

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 ]

Enrollment: 0
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

Locations
United States, Iowa
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Sponsors and Collaborators
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwest Oncology Group
Investigators
Study Chair: Minetta C. Liu, MD Lombardi Cancer Research Center
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:
No publications provided

ClinicalTrials.gov Identifier: NCT00899509     History of Changes
Other Study ID Numbers: CDR0000285697, CALGB-159905, ECOG-C159905, NCCTG-C159905, SWOG-C159905
Study First Received: May 9, 2009
Last Updated: July 15, 2013
Health Authority: Unspecified

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014