ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741
Overview
- Phase
- Not Applicable
- Intervention
- cyclophosphamide
- Conditions
- Breast Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 1195
- Locations
- 1
- Primary Endpoint
- Disease-free survival
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 also help doctors plan the best treatment.
PURPOSE: This research study is looking at tissue samples from women who underwent chemotherapy for lymph node-positive stage II or stage IIIA breast cancer.
Detailed Description
OBJECTIVES: Primary * To identify biomarkers that can be used to individually tailor the use of adjuvant dose-dense therapy in women with stage II or IIIA breast cancer. Secondary * To identify groups of patients who have a poor prognosis despite adjuvant chemotherapy and who should be prospectively targeted for new approaches to adjuvant treatment. OUTLINE: This is a multicenter study. Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1
Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Intervention: cyclophosphamide
Group 1
Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Intervention: doxorubicin hydrochloride
Group 1
Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Intervention: paclitaxel
Group 1
Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Intervention: fluorescence in situ hybridization
Group 1
Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Intervention: immunohistochemistry staining method
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: Up to 5 years
Secondary Outcomes
- Overall survival(Up to 5 years)