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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: December 23, 2009
Last verified: April 2009

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.

Condition Intervention
Breast Cancer
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 1195
Study Start Date: July 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


  • 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).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Menopausal status not specified


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00897026

Sponsors and Collaborators
Cancer and Leukemia Group B
Study Chair: Matthew J. Ellis, MD, PhD, FRCP Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00897026     History of Changes
Other Study ID Numbers: CDR0000589237, CALGB-9741A-ICSC
Study First Received: May 9, 2009
Last Updated: December 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on July 01, 2015