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Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens


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).

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Keith L. Knutson, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000726841

NCT ID:

NCT01562288

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • HER2-positive breast cancer
  • HER2-negative breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

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