Trial record 14 of 1171 for:
Open Studies | "gene therapy"
Gene Expression Profiling and Genetic Analysis of Tissues From Patients With Breast Cancer
This study is currently recruiting participants.
Verified October 2012 by National Cancer Institute (NCI)
Sponsor:
Cancer and Leukemia Group B
Collaborators:
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899509
First received: May 9, 2009
Last updated: October 12, 2012
Last verified: October 2012
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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 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 |
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 | Recruiting |
| Sioux City, Iowa, United States, 51102 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| St. Luke's Regional Medical Center | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
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: | October 12, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 May 16, 2013