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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer

Treatments: Other: immunohistochemistry staining method; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Genetic: fluorescence in situ hybridization; Drug: paclitaxel

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00897026

CALGB-9741A-ICSC

U10CA031946 (U.S. NIH Grant/Contract)

CDR0000589237 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,195 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,195 participants in 1 patient group

Group 1

Description:

Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).

Treatment:

Drug: doxorubicin hydrochloride

Other: immunohistochemistry staining method

Drug: cyclophosphamide

Genetic: fluorescence in situ hybridization

Drug: paclitaxel