Clinical trial · Observational
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
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]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comparative genomic hybridization | Genetic | — | UNRESOLVED |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Disease-free survival
- measure
- Overall survival
Secondary outcomes (1)
- measure
- Distant disease-free recurrence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available