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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 (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01562288
First received: March 21, 2012
Last updated: July 19, 2016
Last verified: July 2016

March 21, 2012
July 19, 2016
February 2012
January 2100   (final data collection date for primary outcome measure)
  • disease-free survival [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: up to 1 month ] [ Designated as safety issue: No ]
  • 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 ]
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
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
Serum and DNA extracted from peripheral blood mononuclear cell samples
Non-Probability Sample
Patients enrolled on NCCTG-N9831.
Breast Cancer
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: polymerase chain reaction
  • Other: enzyme-linked immunosorbent assay
  • Other: laboratory biomarker analysis
Observational
Previously collected serum and DNA from peripheral blood mononuclear cell samples are analyzed for HER2-specific antibodies and FcγR genotype by ELISA and PCR.
Interventions:
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: polymerase chain reaction
  • Other: enzyme-linked immunosorbent assay
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1576
Not Provided
January 2100   (final data collection date for primary outcome measure)

• 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®)

Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01562288
NCCTG-N9831D-NCCTG-ICSC, NCI-2012-00687, CDR0000726841
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Principal Investigator: Keith L. Knutson, MD, PhD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016

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