Status:
COMPLETED
S8814A Biomarkers in Predicting Outcome in Postmenopausal Women With Hormone Receptor-Positive, Node-Positive Breast Cancer Treated With Tamoxifen With or Without Cyclophosphamide, Doxorubicin, and Fluorouracil
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may al...
Detailed Description
OBJECTIVES: Primary * Determine the value of the Oncotype DX Recurrence Score for prediction of treatment benefit of cyclophosphamide, doxorubicin hydrochloride, and fluorouracil (CAF) chemotherapy,...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Node-positive disease (pT1-3a, pN1-2 \[clinical N0-1\], M0)
- Previously enrolled in SWOG-8814, a treatment clinical trial, and in SWOG-9445, a companion tissue banking study
- Tumor block or unstained sections available from initial diagnosis in the SWOG archive
- Sufficient tumor in block or unstained sections
- Patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (RT-PCR) profiles
- Sufficient RNA (≥ 300 ng) for RT-PCR analysis with the Oncotype DX 21 gene assay
- Average normalized cycle threshold for the 5 reference genes ≤ 35
- Follow-up data from the SWOG-8814 clinical trial obtained from the patient
- Hormone receptor status:
- Estrogen and/or progesterone receptor positive tumor
- PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00897091
Start Date
July 1 2006
End Date
October 1 2007
Last Update
May 30 2013
Active Locations (1)
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1
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153