NCT00897091

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

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT00897091

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

Molecular Predictors of Outcome on CAF Plus Tamoxifen Versus Tamoxifen Alone in Postmenopausal Women With Node Positive, Receptor Positive Breast Cancer [NCI Correlative Science Reference No. # 8814A-ICSC]

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 also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at 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.

Eligibility

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

Disease(s) and\or Condition(s)

Breast Cancer

Primary Purpose

Intervention/Treatment

- Type: GENETIC
- Name: comparative genomic hybridization
- Description:
- Arm Group Labels:
- Type: GENETIC
- Name: microarray analysis
- Description:
- Arm Group Labels:
- Type: GENETIC
- Name: reverse transcriptase-polymerase chain reaction
- Description:
- Arm Group Labels:
- Type: OTHER
- Name: diagnostic laboratory biomarker analysis
- Description:
- Arm Group Labels:

Sponsor

SWOG Cancer Research Network