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Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01562288
First received: March 21, 2012
Last updated: February 1, 2013
Last verified: March 2012
History of Changes

March 21, 2012
February 1, 2013
January 2013
February 2013   (final data collection date for primary outcome measure)
  • Magnitude of the antibody responses and the proportion of patients with an antibody response in each of the arms using ANOVA F-test followed by Tukey pairwise comparisons [ Designated as safety issue: No ]
  • Duration of disease-free survival (DFS) plotted using four Kaplan-Meier curves and interaction between arms will be investigated using Cox proportional hazards model [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562288 on ClinicalTrials.gov Archive Site
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Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab
Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens

RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.

OBJECTIVES:

  • To determine the role of trastuzumab in the generation of HER2-specific antibodies in breast cancer patients undergoing adjuvant combination therapy.
  • To determine whether the improved disease-free period and overall survival of patients treated in the adjuvant setting with combination of chemotherapy and trastuzumab is dependent on the Fcγ receptor genotype of the patient.

OUTLINE: Previously collected serum and DNA samples are analyzed for HER2-specific antibodies and FcγR genotype by enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR).
Observational
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Breast Cancer
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: polymerase chain reaction
  • Other: enzyme-linked immunosorbent assay
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1576
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February 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831

    • Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01562288
CDR0000726841, NCCTG-N9831D-NCCTG-ICSC
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Keith L. Knutson, Mayo Clinic Cancer Center
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Principal Investigator: Keith L. Knutson, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP