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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by NSABP Foundation Inc.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: August 19, 2011
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

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
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer

Resource links provided by NLM:

Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR [ Time Frame: approximately 4 years ]
  • Identification of a subgroup of patients who may or may not need radiotherapy after surgery [ Time Frame: approximately 4 years ]
  • 21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients [ Time Frame: approximately 4 years ]

Estimated Enrollment: 1300
Study Start Date: October 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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).


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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stored tissue from participants in protocol NSABP B-28.


  • 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 and tamoxifen with or without paclitaxel


  • Menopausal status not specified


  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420185

Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
Principal Investigator: Terry Mamounas, MD, MPH, FACS Aultman Cancer Center at Aultman Hospital
  More Information

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT01420185     History of Changes
Other Study ID Numbers: NSABP B-28 ICSCA
First Submitted: August 18, 2011
First Posted: August 19, 2011
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by NSABP Foundation Inc:
estrogen receptor-positive breast cancer
stage II breast cancer
stage IIIA breast cancer

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