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Study of Tissue Samples From Women Treated With Paclitaxel for Breast Cancer on Clinical Trial CALGB-9344 or CALGB-9741

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00991263
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tissue samples from women treated with paclitaxel for breast cancer on clinical trial CALGB 9344 or CALGB 9741.

Condition or disease Intervention/treatment
Breast Cancer Genetic: gene expression analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 3677 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intrinsic Breast Cancer Subtypes and Benefit of Paclitaxel in CALGB 9344 and Dose Dense Therapy in CALGB 9741
Study Start Date : April 2009
Primary Completion Date : May 2010
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1
Tissue blocks from CALGB-9344 and CALGB-9741 are utilized to purify RNA to be tested in the PAM50 assay (a 50-gene quantitative PCR assay, that provides an intrinsic breast cancer subtype diagnosis) and generate risk of relapse (ROR) scores. For more information, see Details section.
Genetic: gene expression analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. 5- and 10-year DFS rates [ Time Frame: Up to 10 years ]
  2. Overall survival [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
Tumor tissue samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with breast cancer previously treated with paclitaxel and enrolled on CALGB-9344 or CALGB-9741.


  • Diagnosis of stage II or IIIA breast cancer

    • Received treatment with paclitaxel on clinical trial CALGB-9344 or CALGB-9741
  • Tissue blocks available


  • See Disease Characteristics
  • Pre-, peri-, or postmenopausal


  • See Disease Characteristics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991263

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Matthew J. Ellis, MD, PhD, FRCP Washington University Siteman Cancer Center
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00991263     History of Changes
Other Study ID Numbers: CALGB-159905C-ICSC
CDR0000647570 ( Registry Identifier: NCI Physician Data Query )
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action