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Completed

NCT Number: NCT01562288

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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®)

Treatment and study plan

DNA analysis

Genetic

gene expression analysis

Genetic

polymerase chain reaction

Genetic

enzyme-linked immunosorbent assay

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. disease-free survival

    Time frame: up to 1 month

  2. overall survival

    Time frame: up to 1 month

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2012
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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