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

NCT00897026 | Completed

• 3 other identifiers: CALGB-9741A-ICSCU10CA031946CDR0000589237
• Study Type: observational
• Target: 1,195
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Up to 5 years

Secondary Outcomes (1)

• Overall survival

  Up to 5 years

Study Arms (1)

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).

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

Interventions

cyclophosphamide DRUG

Group 1

doxorubicin hydrochloride DRUG

Group 1

paclitaxel DRUG

Group 1

fluorescence in situ hybridization GENETIC

Group 1

immunohistochemistry staining method OTHER

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years and older diagnosed with node-positive breast cancer.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Doxorubicin; Paclitaxel; In Situ Hybridization, Fluorescence; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Histocytochemistry; Immunologic Techniques

Study Officials

• Matthew Ellis, MD, PhD, FRCP

  Washington University Siteman Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: July 1, 2008
• Primary Completion: April 27, 2012
• Study Completion: April 27, 2012
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)