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

NCT ID: NCT00897026

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-04-27

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

fluorescence in situ hybridization

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

Interventions

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cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

fluorescence in situ hybridization

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of node-positive breast cancer

* Stage II-IIIA disease
* Underwent adjuvant chemotherapy on trial CLB-9741 or CLB-9344
* Hormone receptor status not specified
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Ellis, MD, PhD, FRCP

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-9741A-ICSC

Identifier Type: -

Identifier Source: secondary_id

CDR0000589237

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-9741A-ICSC

Identifier Type: -

Identifier Source: org_study_id

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