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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00897026
First received: May 9, 2009
Last updated: July 23, 2015
Last verified: July 2015
  Purpose

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
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1195
Study Start Date: July 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897026

Contacts
Contact: Matthew J. Ellis, MD, PhD, FRCP (713) 798-1999

Locations
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Matthew Ellis, MD    713-798-1999      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Matthew J. Ellis, MD, PhD, FRCP Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00897026     History of Changes
Other Study ID Numbers: CALGB-9741A-ICSC, U10CA031946, CALGB-9741A-ICSC, CDR0000589237
Study First Received: May 9, 2009
Last Updated: July 23, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 27, 2015