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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Genetic: fluorescence in situ hybridization; Other: immunohistochemistry staining method

• Registration Number: NCT00897026
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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).

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2012-04-27
• Study Completion: 2012-04-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	fluorescence in situ hybridization	Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Group 1	immunohistochemistry staining method	Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Group 1	paclitaxel	Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Group 1	cyclophosphamide	Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).
Group 1	doxorubicin hydrochloride	Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).

Primary Outcome Measures

Name	Time	Method
Disease-free survival	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 5 years

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States