NCT00897026

Studying Tissue Samples From Women Who Underwent Chemotherapy for Lymph Node-Positive Stage II or Stage IIIA Breast Cancer on Clinical Trial CLB-9741 or CLB-9344

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,195 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	paclitaxel
GENETIC	fluorescence in situ hybridization
OTHER	immunohistochemistry staining method

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-04-27
• Completion: 2012-04-27
• First posted: 2009-05-12
• Last updated: 2021-08-17

Locations

1 site across 1 country: United States