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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer

Treatments: Other: laboratory biomarker analysis; Genetic: DNA analysis; Genetic: polymerase chain reaction; Genetic: gene expression analysis; Other: enzyme-linked immunosorbent assay

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01562288

NCCTG-N9831D-NCCTG-ICSC

CDR0000726841 (Registry Identifier)

NCI-2012-00687 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,576 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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®)

Trial design

1,576 participants in 1 patient group

Observational

Description:

Previously collected serum and DNA from peripheral blood mononuclear cell samples are analyzed for HER2-specific antibodies and FcγR genotype by ELISA and PCR.

Treatment:

Genetic: gene expression analysis

Other: enzyme-linked immunosorbent assay

Other: laboratory biomarker analysis

Genetic: DNA analysis

Genetic: polymerase chain reaction