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
  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
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Serum and DNA extracted from peripheral blood mononuclear cell samples

Estimated Enrollment: 1576
Study Start Date: February 2012
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymerase chain reaction Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis

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   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled on NCCTG-N9831.
Criteria

• 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®)

  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
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Principal Investigator: Keith L. Knutson, MD, PhD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology
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 19, 2016
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

ClinicalTrials.gov processed this record on July 25, 2016