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NCT01562288 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01562288
Other study ID # NCCTG-N9831D-NCCTG-ICSC
Secondary ID NCI-2012-00687CD
Status Completed
Phase
First received
Last updated
Start date February 2012
Est. completion date April 2019

Study information
Verified date July 2019
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 1576
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility • 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®)

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• gene expression analysis

• polymerase chain reaction

Other:
• enzyme-linked immunosorbent assay

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary disease-free survival up to 1 month
Primary overall survival up to 1 month
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