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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 16, 2014