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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01562288
First received: March 21, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: enzyme-linked immunosorbent assay
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: February 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562288

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Keith L. Knutson, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Keith L. Knutson, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01562288     History of Changes
Other Study ID Numbers: NCCTG-N9831D-NCCTG-ICSC, NCI-2012-00687, CDR0000726841
Study First Received: March 21, 2012
Last Updated: July 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
HER2-positive breast cancer
HER2-negative breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014