Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01420185
First received: August 18, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict whether cancer will come back after treatment.

PURPOSE: This research trial is studying genes that may predict local recurrence in samples from patients with breast cancer. treated on NSABP-B-28


Condition Intervention
Breast Cancer
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR [ Designated as safety issue: No ]
  • Identification of a subgroup of patients who may or may not need radiotherapy after surgery [ Designated as safety issue: No ]
  • 21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: August 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To evaluate the association between the 21-gene Recurrence Score and risk of local-regional recurrence (LRR) in node-positive, estrogen receptor- (ER) positive (+) patients treated with cyclophosphamide and doxorubicin hydrochloride (AC) with or without paclitaxel in the NSABP-B-28 trial.
  • To evaluate the potential for combining the 21-gene Recurrence Score (RS) with traditional clinico-pathologic factors in order to derive an improved algorithm for prediction of LRR risk and in order to identify subgroups of ER-positive patients with 1-3 or 4 or more positive nodes who do/do not need post mastectomy chest wall radiotherapy (XRT) or regional nodal XRT (irrespective of surgical procedure).
  • To evaluate whether the 21-gene RS predicts benefit from adding paclitaxel to AC chemotherapy in reducing risk of LRR, and improving disease-free survival (DFS) and overall survival (OS) in node-positive, ER-positive patients from NSABP-B-28.

OUTLINE: RNA extracted from paraffin-embedded tissue samples are analyzed for gene expression profile by Ribogreen assay and RT-PCR. Results are then compared and analyzed with each patient clinical-pathologic factors, including tumor size, patient age, number of positive nodes (1-3, 4+), tumor grade, and surgery type (mastectomy or lumpectomy).

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with breast cancer and enrolled on NSABP-B-28.

    • Estrogen-receptor positive (ER+)
    • Node-positive disease
  • Primary tumor tissue samples available
  • Treated with cyclophosphamide and doxorubicin hydrochloride with or without paclitaxel

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01420185

Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Principal Investigator: Terry Mamounas, MD, MPH, FACS Aultman Cancer Center at Aultman Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project
ClinicalTrials.gov Identifier: NCT01420185     History of Changes
Other Study ID Numbers: CDR0000709145, NSABP-B28-ICSC-A
Study First Received: August 18, 2011
Last Updated: August 18, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
estrogen receptor-positive breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014