Studying Blood and DNA Samples From Patients With Breast Cancer Treated With Chemotherapy With or Without Trastuzumab
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymerase chain reaction Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Adjuvant Chemotherapy Combined With Trastuzumab in the Randomized Phase III Trial N9831 Actively Immunizes Patients Against Tumor Antigens |
- 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 [ Designated as safety issue: No ]
- Duration of disease-free survival (DFS) plotted using four Kaplan-Meier curves and interaction between arms will be investigated using Cox proportional hazards model [ Designated as safety issue: No ]
| Estimated Enrollment: | 1576 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Keith L. Knutson, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01562288 History of Changes |
| Other Study ID Numbers: | CDR0000726841, NCCTG-N9831D-NCCTG-ICSC |
| Study First Received: | March 21, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
HER2-positive breast cancer HER2-negative breast cancer stage IA breast cancer |
stage IB breast cancer stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013