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NCT00897026 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00897026
Other study ID # CALGB-9741A-ICSC
Secondary ID U10CA031946CALGB
Status Completed
Phase
First received
Last updated
Start date July 2008
Est. completion date April 27, 2012

Study information
Verified date August 2021
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 1195
Est. completion date April 27, 2012
Est. primary completion date April 27, 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• paclitaxel

Genetic:
• fluorescence in situ hybridization

Other:
• immunohistochemistry staining method

Locations
Country Name City State
United States Washington University Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-free survival Up to 5 years
Secondary Overall survival Up to 5 years
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