NCT01562288

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,576 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	gene expression analysis
GENETIC	polymerase chain reaction
OTHER	enzyme-linked immunosorbent assay
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2012-02-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2012-03-23
• Last updated: 2019-07-02