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Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01424865
First received: August 26, 2011
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

RATIONALE: Studying samples of 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.

PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.


Condition Intervention
Breast Cancer
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Evaluation of the Co-Expression of the Cancer Stem Cell Marker ALDH1 and of HER2 as a Predictor of Adjuvant Trastuzumab Response in Breast Cancers of Women in NSABP B31

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ALDH1 expression (percentage of stem cells within the tumor) and association with outcomes regardless of HER2 staining [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HER2 expression in cells with stem cell-like properties as a determinant of aggressiveness and response to trastuzumab in the adjuvant setting [ Designated as safety issue: No ]

Estimated Enrollment: 1874
Study Start Date: November 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine if stem cellness identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with either adjuvant doxorubicin hydrochloride & cyclophosphamide followed by paclitaxel (the "control arm" of B31), or the same chemotherapy plus trastuzumab.

Secondary

  • To conduct exploratory analyses to assess, to the extent possible, if co-localization of stem cellness, as determined by ALDH1 positivity, and HER2 identifies a group of patients previously considered to have HER2-negative cancers (using classical definitions) who benefit from adjuvant trastuzumab.

OUTLINE: Archived breast cancer stem cells samples and terminally differentiated cells from tissue samples are analyzed for HER2 and ALDH1 expression by dual-staining quantitative immunofluorescence using Automated Quantitative Analysis (AQUA) , IHC, and fluorescence in situ hybridization (FISH).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Tissue samples from patients with node-positive breast cancer whose tumors overexpress HER2
  • Primary tumor samples that are negative for HER2 using classically accepted cutoffs determined in the metastatic setting
  • Treated with adjuvant therapy comprising doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in the NSABP-B-31 trial

PATIENT CHARACTERISTICS:

  • 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: NCT01424865

Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Principal Investigator: Daniel F. Hayes, MD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project
ClinicalTrials.gov Identifier: NCT01424865     History of Changes
Other Study ID Numbers: CDR0000709673, NSABP-B31-ICSC-A
Study First Received: August 26, 2011
Last Updated: November 29, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
HER2-positive breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014